Model Number N/A |
Device Problem
Break (1069)
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Patient Problem
No Information (3190)
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Event Date 06/20/2019 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Concomitant medical products:: unknown tibial tray; unknown tibial bearing.Foreign country: (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, due to location of the device 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 that device has had repeated failure of the coupling mechanism (lock break).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.The device history record was reviewed and no discrepancies relevant to the reported event were found.Per the segmental system package insert, fracture/damage of the prosthetic knee components is a known potential adverse effect of this procedure.A definitive root cause cannot 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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