Model Number N/A |
Device Problem
Difficult to Insert (1316)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 02/12/2018 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Additional concomitant medical products: 00500104428, pe bipolar liner, 63848868.(b)(6).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.Multiple mdr reports were filed for this event, please see associated reports: 0002648920 - 2018 - 00174.
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Event Description
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It was reported that the insert does not fit into the cup because the ring was locked.The surgery was completed with another implant.Attempts have been made and additional information on the reported event is unavailable.
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Manufacturer Narrative
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(b)(4).This follow-up report is being submitted to relay additional information.
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Event Description
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No additional event information to report at this time.
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Manufacturer Narrative
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Udi: (b)(4).Complaint sample was evaluated and the reported event was confirmed.As returned, the liner and poly ring are severely damaged.The poly locking ring is out of place, likely from removal of the femoral head.Subsequently, an identation was identified on the outer circumference of the liner indicative of an unsuccessful attempt to assemble the liner with the shell/locking ring.The shell was returned with one of two tabs of the locking ring seized in the locking ring groove.Dimensional readings of the locking ring and locking ring groove are conforming to print specifications.Dhr was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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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Search Alerts/Recalls
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