Model Number N/A |
Device Problem
Difficult to Insert (1316)
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Patient Problem
No Code Available (3191)
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Event Date 01/10/2019 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Concomitant medical products: item# 110017106 g7 finned 4 hole shell 58g lot# 6363413; item# 010000820 g7 hi-wall arcomxl lnr 36mm g lot# 6316884; item# unknown unknown head lot# unknown; item# unknown unknown stem lot# unknown.(b)(6).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 mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2019 - 00310, 0001825034 - 2019 - 00308.
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Event Description
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It was reported that during initial surgery for implantation, liner would not seat in shell.Surgeon attempted a different liner and it would not seat as well.Surgeon explanted cup and then seated liner with first attempt.Procedure was delayed 45 minutes.Attempts were made to obtain additional information; however, none is available.
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Manufacturer Narrative
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(b)(4).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.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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