Database of Zimmer NexGen knee replacement problems

Here are some real-world Zimmer NexGen knee replacement problems taken directly from the FDA adverse events database. The problems were chosen randomly over five months in 2008. The catalog number and full date were omitted for privacy purposes. Of course, it is of no surprise that Zimmer has defended these problems by blaming the surgeons for errors instead of the problem being with the device itself.

ZIMMER, INC. NEXGEN COMPLETE KNEE SOLUTION MIS TOTAL KNEE PROCEDURE TIBIA BASEPLATE KNEE PROSTHESIS

Device Problem - Loose
Event Date - 11/XX/2008
Event Type - Malfunction

Manufacturer Narrative
Evaluation summary: it is reported that the bone cement was used for only the surface of the proximal tibia and not for the keel and stem. Improper cementing technique appears to be the cause of the tibial plate loosening because the surgical technique recommends for the use of cement in the im canal which will give a cement mantle around the keel and stem also. No product was returned. Review of the device history records was also not possible as the product and/or lot numbers required for retrieval were unavailable. It is not suspected that the product failed to meet specifications. The investigation could not verify or identify and evidence of product contribution to the reported problem. Based on the available information, the need for corrective action is not indicated. Should additional substantive information be received, the complaint will be reopened. Zimmer, inc. Considers the investigation closed.

Event Description
It is reported that the surgeon has 5 patients whose tibial trays have loosened within a month after tka. In all cases, bone cement was used for only the surface of proximal tibia, but not for keel and stem. There was no loosening in the case whose keel and stem of tibial component was cemented. Implant date is unknown. It is unknown if the patient has been revised.

ZIMMER, INC. NEXGEN COMPLETE KNEE SOLUTION MIS TOTAL KNEE PROCEDURE STEMMED TIBIAL COMPONENT KNEE PROSTHESIS

Device Problem - Loose
Event Date 09/XX/2008
Event Type – Injury, Patient Outcome - Hospitalization; Required Intervention

Manufacturer Narrative
Evaluation summary: as returned, the tibial component exhibited bone cement and deposits of bone tissue on the undersurface of the tibial component and around the keel. The articular surface exhibits pitting on the articulating surfaces and deep gouges. The x-rays that were provided for review depict a significant radiolucency on the lateral side of the tibial between the cement and the bone and opaque spots anteriorly near the tibial component. Additionally, the joint liner of the left knee appears to be lower than that of the right knee as seen in the "wt bearing" x-ray. Immediate post-op x-rays were not available and may provide additional info. The cause of the tibial component loosening cannot be definitively determined based on the available info. Evaluation codes: device history records indicate all components were manufactured and inspected to specification.

Event Description
It is reported that the device was implanted in 2006, and was explanted in 2008 due to the tibial becoming loose.

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ZIMMER, INC. NEXGEN COMPLETE KNEE SOLUTION MIS TOTAL KNEE PROCEDURE STEMMED TIBIAL COMPONENT KNEE PROSTHESIS

Device Problems - Explanted; Migration of device or device component
Event Date - 07/XX/2008
Event Type - Injury, Patient Outcome Hospitalization; Required Intervention

Manufacturer Narrative
Eval summary: it is reported that the knee was revised 1 yr and 1 month post-op due to the tibial plate being internally rotated. The pt is a female. The weight and activity level of the pt is unk. Product was not returned for eval. Also, the post-op x-rays are not available for review. The cause of the tibial plate being internally rotated could not be definitely determined, however, improper technique during bone preparation could be a contributing factor. Eval codes: no product was returned. Review of the device history records did not find any deviations or anomalies. It is not suspected that the product failed to meet specs. The investigation could not verify or identify any evidence of product contribution to the reported problem. Based on the investigation, the need for corrective action is not indicated. Should additional substantive info be received, the complaint will be reopened. Zimmer, inc. Considers this investigation closed.

Event Description
It is reported that the device was implanted in 2007 and was explanted in 2008, due to the tibia being internally rotated.

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