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Model Number N/A |
Device Problem
Difficult to Insert (1316)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 03/18/2020 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Concomitant medical products: biomet g7 10 deg arcomxl liner 40mm h: cat# 010000788, lot# 3787184.The device will not be returned for analysis, per hospital policy; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2020-02006.
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Event Description
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It was reported that during the revision, the osseoti multi shell was implanted per technique without issue.An attempt was made to insert the 10 degree 40mm arc liner per technique.While the liner appeared to the surgeon eye to be satisfactory, a tug on the liner lip immediately resulted in the liner coming out of the shell.After multiple attempts to implant the liner, and after checking the liner for damage, it was determined that the liner was defective.A 10 degree 36mm liner was then implanted, yet same result as the prior liner, no success.The noted shell was removed and a 4 hole osseoti same size was implanted with screws to follow.The 10 degree 36mm liner previously used was inspected for damage and implanted, without issue.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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This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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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Event Description
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No further event information available at the time of this report.
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Search Alerts/Recalls
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