Investigation results were made available.As for zimmer specialists to perform an in-depth analysis it is required to have all necessary information at hand, it was therefore tried several times to receive additional information for this case.Currently, additional information is not available.Dhr-review: as no lot numbers were provided for the devices, the device history records could not be reviewed.The missing device information has been requested but was not available.At zimmer gmbh all medical devices prior release to market undergo several quality inspections as defined in our quality procedures.Our quality inspection- and deviation procedures ensure that only products fulfilling the specification are sold.These procedures are part of the overall quality management system at zimmer gmbh and get regularly audited by our notified body, competent authorities and internal and external auditors.Thus, for all products sold to the market can be assumed having a complete and correct dhr.Trend analysis: analysis could not be performed as no item number is available.Event description: it was reported that the product was implanted on (b)(6) 2017 and the patient is experiencing wound redness after revision surgery.Review of received data: no medical data such as x-rays, surgical notes or any other case-relevant documents received.Devices analysis: no product was returned to zimmer biomet for in-depth analysis.Review of product documentation: this device is intended for treatment.Conclusion summary: it was reported that the patient is experiencing wound redness and is being monitored.Product was implanted on may 30, 2017.In vivo time of the device is unknown.The dhr check could not be performed as the lot number was not available.The compatibility check could not be performed as no product information was provided.The investigation results did not identify a non-conformance or a complaint out of box (coob).Neither x-rays, operative notes, office visit notes, nor devices or photos of the explanted implant were received; therefore the condition of the component is unknown.Patient factors that may affect 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 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 gmbh considers this case as closed.Zimmer biomet's reference number of this file is (b)(6).
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