Patient was implanted on an unknown side and after implantation the patient started experiencing pain, extreme swelling and limited range of motion.Patient gained weight post implantation.Hence, the patient went for second opinion and from the x-rays it was told to her that the screws were too long and there were no end caps on the screws.
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Investigation results were made available.Event description: it was reported that patient had a distal femur fracture which was treated with ncba periprosthetic femur plate.Post-implantation the patient started experiencing pain, extreme swelling around her knee and limited range of motion.Review of received data: no medical data relevant to the case has been received.- x-rays: images were provided which are a xeroxed copy of actual x-ray and are grainy and of poor quality.Therefore, an assessment was not possible.Product evaluation: no product was returned as it remains implanted; therefore, visual and dimensional evaluation could not be performed.Review of product documentation: - device purpose: all involved devices are intended for treatment.- product compatibility: the product combination was approved by zimmer biomet.- dhr review: review of the device history records could not be performed as the lot numbers of the devices were not available.- instruction for use (ifu): the applicable instruction for use (ifu) was reviewed with no anomalies noted.Conclusion: it was reported that patient had a distal femur fracture which was treated with ncba periprosthetic femur plate.Post-implantation the patient started experiencing pain, extreme swelling around her knee and limited range of motion.Neither operative notes, office visit notes, nor device(s) or photos of the device(s) were received; therefore the condition of the component(s) is unknown.Patient factors that may have affected the performance of the components such as bone quality, activity level, type of activity (low impact vs.High impact), and relevant medical history are unknown.Adherence to rehabilitation protocol is unknown.Based on the investigation the reported event cannot be confirmed.Due to significant lack of information a detailed investigation could not be performed, nevertheless based on the given information there is no indication of a nonconformance or complaint out of box (coob).Based on the given information and the results of the investigation, we were not able to identify a specific root cause for this issue.The need for corrective measures is not indicated and zimmer switzerland manufacturing gmbh considers this case as closed.Zimmer biomet's reference number of this file is (b)(4).The following reports are associated with this event: 0009613350-2021-00043-1, 0009613350-2021-00045-1, 0009613350-2021-00046-1, 0009613350-2021-00044-1, 0009613350-2021-00041-1, 0009613350-2021-00047-1, and 0009613350-2021-00042-1.
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