This follow-up report is being filled to relay investigation result.Additional and corrected information are filled in the following fields: additional: h2 - h6; correction: b4 - g4 - g7 - h10.Dhr review: as no lot number was provided, the device history records could not be reviewed.Trend analysis: no trend analysis could be performed as no item number(s) is/are available.Event description: it was reported that the product mentioned in journal article was implanted on unknown date and head collapsed after resurfacing.It is unknown whether revision took place.Review of received data: no medical data such as x-rays, surgical notes or any other case-relevant documents received.Device analysis: no product was returned to zimmer biomet for in-depth analysis.Review of product documentation: this device is intended for treatment.The compatibility check could not be performed as there is no item# reported.Conclusion: it was reported that the product mentioned in journal article was implanted on unknown date and head collapsed after resurfacing.It is unknown whether revision took place.In vivo time of the device is unknown.The investigation results did not identify a non-conformance or a complaint out of box (coob).However, based on the available information, we were not able to identify an exact 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)(4).
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