Model Number N/A |
Device Problems
Difficult to Insert (1316); Difficult To Position (1467)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 04/02/2018 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Concomitant medical products: 00875200832, liner elevated rim 32 mm i.D.Size gg for use with 48 mm o.D.Size gg shell, 63746657.(b)(6).Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2018-03545.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
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Event Description
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It was reported that during the left total hip arthroplasty, after implanting the shell, the liner couldn't be seated in the shell.Subsequently the surgeon completed the surgery with a different shell and liner.Delay of 40 minutes was noted.Attempts have been made and additional information on the reported event is unavailable.
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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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Complaint sample was evaluated and the reported event was not confirmed.Damage in the form of gouges and scratched along the elevated rim of the liner and on the inner radius of the liner were noted.Nicks and scratches were noted on the shell near the elevated portion of the liner.Dhr was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to be determined.A summary of the investigation has been sent to the complainant.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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Search Alerts/Recalls
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