The U.S. Food and Drug Administration has issued a Class 1 recall for a handheld instrument used during hip-replacement surgery. The device failed sterility tests.
Greatbatch Medical Recalls The Affected Instrument
Greatbatch Medical recalled the instrument, a Standard Offset Cup Impactor. The instrument enables doctors to implant cups and balls in the joint area after the removal of their orthopedic counterparts – the acetabulum and the femoral head. The directions on how to decontaminate the instrument in its accompanying case were inadequate.
“Non-sterile surgical devices can lead to infections, and other serious adverse health consequences, including death,” the FDA states on its Web site, noting the company has since updated the sterilization process to meet federal standards.
Greatbatch Medical, in July of 2016, initiated corrective action on the recalled instrument. They determined the device must be individually wrapped for sterilization to be successful. The company says no adverse events have been reported.
“Greatbatch Medical has notified its distributors and customers via overnight mail that Standard Offset Cup Impactor with POM-C Handle grip should be individually wrapped during sterilization processing,” according to a corporate press release.
Urgent Field Safety Notice Contact Information
The instruments in question were made between 2004 and 2013 and distributed through 2015. Consumers can call (619) 498-9487 or email firstname.lastname@example.org with any questions or concerns.
“Torque limiting devices are supplied non-sterile and require cleaning and steam sterilization prior to use and subsequent re-use,” states an Urgent Field Safety Notice released by Greatbatch Medical. “This issue carries with it the possibility of patient infection. We deeply regret this inconvenience, but we greatly appreciate your understanding as we take actions to ensure patient and customer satisfaction.”
A company beneath the umbrella of pharmaceutical giant Pfizer has initiated a clawback of its recalled EpiPen Auto-Injector and EpiPen Jr Auto-Injector for failing to activate in time of need.
The U.S. Food and Drug Administration notified the public March 31, 2017 about the recall by Meridian Medical Technologies / Mylan N.V. The agency stated in a news release that 13 lots of the epinephrine-injection products might have a defective part.
“While the number of reported failures is small, EpiPen products that potentially contain a defective part are being recalled because of the potential for life-threatening risk if a severe allergic reaction goes untreated,” according to the release.
There have been two instances of the device failing outside the United States that have put users at risk of anaphylaxis – an allergic reaction so severe that it is life-threatening. The recall was initiated domestically and will be implemented in markets in Asia, Europe and South America. Still, the FDA asks consumers who require the devices to keep them until a replacement is obtained. None of the 13 lots in question affects the generic EpiPen Auto-Injector, also manufactured by Meridian Medical Technologies.
“The authorized generic has the exact same drug formulation, has the exact same operating instructions and is therapeutically equivalent to EpiPen Auto Injector, and may be substituted for EpiPen Auto Injector,” Mylan N.V. states on its Web site.
Recommendations in the wake of the recall are for consumers to visit mylan.com/epipenrecall for information and updates and to learn how and where to return their device once a replacement is obtained. Healthcare practitioners are asked to report any adverse events involving the EpiPen Auto-Injector or EpiPen Jr Auto-Injector by downloading an FDA form. They also can call 800-332-1088.
Endotoxins, or lipopolysaccharides, can cause septic shock if introduced to the body in large amounts.
Following closely its recall of its reverse total shoulder implants, Zimmer Biomet recalls plastic and ceramic implant parts that are contaminated with endotoxins. Health Canada classifies the recalled products as posing a Type I Hazard.
The FDA has adopted approved standards for the presence of acceptable levels of endotoxins in orthopedic devices. This recall was announced after Zimmer Biomet found excessive levels of endotoxins in a sampling of devices. Endotoxins are toxins associated with the outer membrane of bacteria. In large enough quantities, endotoxins can cause hemorrhagic shock and severe diarrhea. Smaller amounts can cause fever and altered resistance to bacterial infection as well as other biologic effects. The release of endotoxins from bacteria can also impact other important physiologic processes as seen below.
As a result of the recall, Zimmer Biomet has communicated with surgeons and hospitals known to have implanted the recalled devices. The communication however does not give surgeons any specific advice as to what to do for the patient and no recommendation for treatment other than to follow the patient’s normal routine follow up schedule.
Only time will tell how many patients are adversely affected and what the consequences of these contaminated, recalled products will be.
In December 2016 Zimmer issued a Class one recall of its Comprehensive Reverse Shoulder Implant System Humeral Tray. Zimmer received 510(K) clearance to market this device in 2008. According to the FDA’s Recall Database, approximately 300 lots of the shoulder implant are being recalled because of a higher than anticipated rate of fracture due to design. In other words, too many of them are breaking after being implanted. The fracture of any orthopedic device typically results in the need for emergent, premature revision surgery. Although no orthopedic implant is perfect, a consumer should be able to assume that a responsible company’s robust design and manufacturing process would ensure that the device should not break. But, as we are seeing all too often, the “me too” 510(K) clearance process allows companies to self-police with virtually no oversight from the FDA.
Over the past ten years, orthopedic device manufacturers have sold a number of defective products resulting in the need for premature and unnecessary revision surgery. Although patients with failed hip or knee implants can have terrible complications from revision surgery, many do well. The human hip and knee have ample bone stock on both the hip and leg bones to accommodate a second replacement device. The revising surgeon has the ability to simply drill bigger holes and place larger revision implants. As long as the device failure did not cause substantial muscle or soft tissue damage prior to revision, many patients can do well following revision.
However, patients who undergo shoulder replacement have very little bone stock on the shoulder side or what is technically referred to as the scapula. As a result, even under the best of circumstances, performing a successful shoulder replacement is challenging. Most shoulder replacement components, including Zimmer Biomet’s, rely on screws to fix the implant to the patient’s scapula. At the point where the screws insert, the scapula is very narrow. In fact, the screws are almost as wide as the bone. In the picture below, the “shoulder side” of the implant would essentially take the place of the glenoid cavity. The screws that hold the shoulder side of the implant would go directly into the scapula. As you can see, there is very little bone there.
What that means for a patient who suffers a fracture of the shoulder side component or “base plate” is that the screws must be removed. This leaves large holes in the scapula, making it extremely challenging for the surgeon to put a replacement implant in place. There just is not much bone to work with. As a result, the probability that the patient’s revision shoulder replacement will last very long is not good. There’s no bone left to hold it in place.
Since Zimmer Biomet’s recall is for fracture of the base plate, there is no option but to remove the screws and replace that portion of the device. For patients who suffer this unfortunate and preventable failure, all hope of having a successful and long-term shoulder implant is lost. You essentially have one shot to get a complete shoulder replacement right. Device fracture ruins that chance and leaves the patient facing the potential of a life of disability.
Currently, the orthopedic and scientific community is trying to grasp the scope and danger associated with corrosion and fretting failures at the femoral head and stem interface or trunnion. Every manufacturer has thousands if not hundreds of thousands of titanium stems with metal femoral heads implanted in patients so this is a huge issue.
Why the sudden uptick in failures? I believe two factors are relevant. First, over the past ten years manufacturers have designed and released larger and larger metal heads. They have done so under the guise of providing surgeons with an option that will lessen the risk of dislocation. Since the true risk of dislocation in competent hands is less than 2%, this is another example of industry creating a solution to a problem that does not exist. It only provides yet another marketing advantage. At the same time, trunnions and neck profiles have gotten smaller and smaller under the guise of lessening the risk of impingement. Again, a risk that is extremely low in competent hands. Skilled surgeons tell me that if an implant is placed in correct, anatomic alignment the hip will not dislocate or impinge.
Second, since most of these devices are not “recalled” many surgeons have simply failed to make the appropriate diagnosis leading to under reporting of adverse events. Metal wear disease is a relatively new concept in orthopedics. As such, non-recalled devices don’t raise eyebrows when patients return complaining of pain and limited mobility. I’ve seen surgeons follow such patients for years giving repeated steroid injections, aspirating the hip, suspecting infection and sending patients back to rehab without ever making the correct diagnosis. So, simple lack of recognition has led to under-reporting. But, more recently the medical literature has started to address this situation. Stryker recently recalled thousands of metal heads. The issue is becoming more prominent leading to quicker, more accurate diagnosis. The issue has simply risen to the top.
When Trunnions Get Smaller and Heads Get Larger
What is the result of smaller trunnions, lower profile necks and larger heads? Well, if you were to pose that question to Sir John Charnley over 50 years ago he would say that larger heads increase the rotational forces on the head (torque) which is directly transferred to the head/neck interface (trunnion). As trunnions get smaller, the larger forces created by larger heads are borne by smaller surface contact. The result is more motion at the interface between head and stem. Motion = fretting or wearing away of the metal (actually the passive layer of oxides that form on the metal) and corrosion occurs. The additional factor of smaller neck profiles exaggerates the motion and simply makes matters worse. The laws of physics did not change over the past 50 years! Why ignore the sage wisdom of your forefathers?
When a titanium stem and metal head (most frequently a chromium/cobalt alloy) move upon one another and corrosion occurs there is actual material loss from both the chrome/cobalt head and the titanium stem. It’s typically microscopic and almost undetectable to the eye. But, the amount of chromium and cobalt that are given off during the corrosion process is substantial and biologically devastating to tissue and bone. Surgeons have taken to calling this failure, “metallosis.”
What Is Metallosis?
Metallosis is simply toxicity to tissue and bone when exposed to chromium and cobalt. Tissue, muscle and bone die. Frequently abnormal masses of tissue grow and these are referred to as pseudotumors. Large collections consisting of milky, purulent appearing fluid can also occur and are often mistaken for infection. If allowed to progress, metallosis can destroy very important muscles as well as bone.
The surgical “fix” for metal wear failure is to remove the offending device and replace it. But, there is substantial debate among surgeons as to what should be removed. Many doctors are simply removing the metal head and replacing it with a ceramic head, leaving the well ingrown femoral stem in place. That would include the potentially worn trunnion upon which the new head is placed. Others are removing both the stem and head out of concern that an “eyeball test” of the trunnion is sufficient.
Surgeons are very hesitant to remove a well ingrown stem. The procedure is time consuming and frequently requires cutting a large window in the femur followed by placing several cables to hold the bone together. Rehabilitation time is greatly increased. Complications are not uncommon. So, if you can get away with leaving the stem, the temptation is to do so. But, at what cost?
I actually attended an American Society for Testing Materials (ASTM) subcommittee on Medical and Surgical Materials meeting devoted entirely to this topic. At that meeting there was substantial disagreement over whether an intraoperative “eyeball test” of a used trunnion was sufficient to insure integrity. I have also spoken with numerous surgeons who have expressed great concern over this issue. They have no idea what the long-term consequence is when a new head is impacted on a worn, used trunnion. It scares them.
L-Fit V40 Head Revisions
Finally, this week I had the opportunity to review a revising surgeon’s pre-operative office note. The surgeon is well-known and was revising a failed Stryker Accolade TMZF stem that had been implanted with Stryker’s L-Fit V40 (Low Friction Ion Treatment) chrome/cobalt head. This surgeon has been a Stryker consultant in the past and has worked on design teams creating new Stryker products. The head was one Stryker has recently recalled (36mm +5). All of the appropriate pre-revision work-up indicated the devices had failed due to metal wear. Even before he performed the surgery, this Stryker consultant planned to remove the stem. In the final pre-operative office note he said, “I would not sleeve this and convert it over to ceramic. There is too much damage to the trunnion.This is a small trunnion and I do not think sleeving these is reasonable.” He made the comment about too much trunnion damage before surgery, well before he even saw it.
This is the first time I have seen a surgeon commit to writing the thought process I have heard so many voice and what some advocated at the ASTM conference. It confirms my suspicion that thought processes are changing and more surgeons are going to be unwilling to leave a worn trunnion/stem in place. Of course, the risks of leaving a worn trunnion behind will not be known until well down the road when and if they fail.