Investigation results were made available.Review of event description: it was reported that during surgery on (b)(6) 2021 the allofit impactor broke during impaction of the shell.The implant was positioned incorrectly.During the attempt to correct the position, the surgeon damaged the implant, leading to replacement of the shell and head.Review of received data: no medical data relevant to the case has been received.Due diligence: no further "due diligence" required as all required information to support the conclusion is available or was already requested.Product evaluation: visual examination: the allofit impactor and the biolox taper liner were sent in for examination.The thread of the allofit impactor has flattened threads.The biolox taper liner shows seating patterns on the rim and numerous light gray stripes.There are some metal smears on the articulation surface.Review of product documentation: device purpose: this device is intended for treatment.Dhr review: review of the device history records identified no relevant deviations or anomalies during manufacturing.Conclusion: it was reported that during surgery on (b)(6) 2021 the allofit impactor broke during impaction of the shell.The implant was positioned incorrectly.During the attempt to correct the position, the surgeon damaged the implant, leading to replacement of the shell and head.The quality records show that all specified characteristics have met the specifications valid at the time of production.Therefore, the investigation did not identify a nonconformance or a complaint out of box (coob).Visual inspection shows damage to the thread of the allofit impactor.Possible causes include the thread being screwed in at an angle.However, a specific root cause could not be determined.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).
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