Model Number N/A |
Device Problem
Migration (4003)
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Patient Problem
No Code Available (3191)
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Event Date 01/17/2020 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device location is unknown. 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 during an initial hip arthroplasty.The echo biometric rpp subsided significantly past the broach when impacted.A larger stem was used to complete the procedure.Attempts were made to obtain additional information; however, none was available.
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Manufacturer Narrative
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Reported event was unable to be confirmed due to limited information received from the customer.Device history record 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.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 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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