M. Robert Blanchard
October 17th 2012 11:30am
In a recently announced string of recalls from the FDA, one name appears to stand out: Zimmer, Inc. In addition to a variety of problems with artificial knees and hips, Zimmer is initiating a recall of its Cemented Tibial Drill for the Persona Personalized Knee System due to three reports being received as of August 29, 2012 for tibial cortex perforation during preparation of the tibial bone. Investigation into the reports that have been received found that the perforations are occurring while using the Cemented Tibial Drill. The perforations have occurred in the anterior medial tibial cortex, particularly when preparing for use of a particular plate. As a result, Zimmer is detailing some important aspects within the surgical technique that mitigate the potential of perforating the tibial cortex. In addition, Zimmer is replacing the current Cemented Tibial Drill with a modified depth indicators for determining how deep to drill for the different sizes of tibial plates. Along with delivering this notification, sales representatives are replacing Cemented Tibial Drills already in use.
Regarding their artificial hips, complaints have been received reporting sub-optimal fit between provisional femoral heads (VerSys and MIS) and the mating components (i.e. stems and provisional femoral necks), in some cases alleging the fit was too tight and in other cases too loose. Some reports of dislodgment during surgery on the provisional head have also been received. Fourteen (14) of the complaints allege that the provisional head was left in-vivo after separating from mating components during surgery. Provisional head dislodging may result from a number of combined factors, including patient body mass, patient soft tissue tension, incision size, and mating taper fit of the provisional.
A number of lawsuits relating to Zimmer medical devices have been initiated around the country by notable mass tort law firms, such as the Florida law firm Levin, Papantonio, whose attorney Daniel Nigh has commented, “Patients should not let themselves be unduly alarmed. Recalls are a not uncommon part of the medical devices industry. Most patients will not have any problems with their hip implant product, so they just need to find out if they have the specific hip implant that has been recalled and discuss this with their doctor.”
M. Robert Blanchard is a former prosecuting attorney, trail lawyer, and writer living in Gulf Breeze, FL.