Catalog Number UNKNOWN |
Device Problem
Detachment of Device or Device Component (2907)
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Patient Problem
Insufficient Information (4580)
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Event Date 07/26/2023 |
Event Type
Injury
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Event Description
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It was reported that the patient was revised due to bearing disassociation approximately six months post implantation.No additional patient consequences were reported.Attempts have been made and additional information on the reported event is unavailable at this time.
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Manufacturer Narrative
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(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001822565 -2023 -02267, 0001825034-2023-02012.D10: comp conv glen liner vivacit-e; cat: 110035767; lot: 65163943; mini tray std cocr +0 offset; cat: 110031399; lot: 65949545; versa-dial/comp ti std taper; cat: 118001; lot: 808600; comp rvrs shldr glnsp std 36mm; cat: 115310; lot: j7505348; hmrl bearing 36 mm std vite; cat: 110031424; lot: 65761078; versa-dial 46x18x53 hum head; cat: 113042; lot: j7298805; versa-dial/comp ti std taper; cat: 118001; lot: j7379786.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up report will be submitted.
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Event Description
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No further event information available at the time of this report.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.No product was returned or pictures provided for the unknown baseplate; visual and dimensional evaluations could not be performed.Medical records for the initial surgery were provided and reviewed by a health care professional.Review of the available records identified the following: rotator cuff intact.Glenoid convertible baseplate.Anatomic total shoulder performed without complications.Intraop imaging show good alignment of components.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.The reported event is not confirmed; the revision is confirmed as pictures were provided and product returned, however the occurrence of disassociation cannot be confirmed.Root cause was unable to be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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Search Alerts/Recalls
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