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| Zimmer Biomet implants with signs of bag adhesion--Courtesy of Zimmer Biomet |
Hospitals around the world are being instructed to inspect more than 730,000 Zimmer Biomet ($ZBH) artificial hip, knee and shoulder implants for signs that they were packaged in a low density polyethylene bag that adhered to the device.
The urgent field safety notice applies to 21 models of Zimmer hip, knee and shoulder implants according to the FDA's recall database. The company estimates that one in 12,800 of the devices has the problem (or about 60 devices in circulation), which causes the outer surface to wear away at the site of the adhesion.
Zimmer wants customers to quarantine the affected devices for removal by a company sales representative.
Luckily, the consequences of the issue do not appear to be very severe. Zimmer says the bags are biocompatible, so their particulates do not pose a risk to patients. Nevertheless, use of one of the devices could extend or delay surgery time by more than 30 minutes as surgeons search for a different implant, the safety notice says.
The FDA labeled the recall Class II, meaning "use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences." It's less severe the Class I designation for devices that could cause "serious adverse health consequences or death."
In the safety notice, Zimmer said that the notification is a follow-up to a warning issued in August 2013. The company later started using a new bag to package the implants following customer complaints, "but has continued to receive complaints that the old LDPE bag containing the implant adheres to the highly polished implant surface."
An inspection of the database of Germany's Federal Institute for Drugs and Medical Devices reveals that the company has issued three other safety notices so far this year, related to incorrect labeling of its M.E. Müller cup, another case of problematic packaging and dental implants that could loosen or fracture.
- read the safety notice
- here's one (out of 21) of the notices in the FDA recall database