Model Number N/A |
Device Problem
Fracture (1260)
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Patient Problem
Foreign Body In Patient (2687)
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Event Type
Injury
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Manufacturer Narrative
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(b)(4).Event and implant date: (b)(6) 2018.Concomitant medical products: g7 pps ltd acet shell 56f, 010000665, 635087.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.
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Event Description
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It was reported that during an initial total hip surgery the tip of the shell inserter broke off and is attached to shell in the patient.Attempts have been made and additional information on the reported event is unavailable at this time.No further information is available.
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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.Dhr was reviewed and no discrepancies relevant to the reported event were found.Dhr was reviewed and no discrepancies relevant to the reported event were found.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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