The reported event was not confirmed, since the device was not returned for evaluation and no other evidences were provided.The device inspection was not possible as the product was not returned for investigation.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.If device is returned or any further information is provided, the investigation report will be reassessed.
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The patient initially had a zb hemi shoulder replacement.The long zb stem was removed, and a revive with perform reverse implant was implanted.The patient later required a second revision to a revive hemi from tornier revive with perform reverse due to significant proximal bone recession.The stem was well fixed, so everything on the glenoid side was removed, and a 52 x 23 flex head was installed.
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