Model Number N/A |
Device Problems
Difficult to Insert (1316); Difficult To Position (1467)
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Patient Problem
No Information (3190)
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Event Type
malfunction
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Manufacturer Narrative
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(b)(4).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.(b)(6).
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Event Description
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It was reported that while assembling the femoral head into the liner, the liner locking ring was deformed causing the implants not to mate.Attempts have been made, and no further information has been provided.
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Manufacturer Narrative
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This report is being submitted to relay additional information.The device was returned to the manufacturer for evaluation.The liner was reviewed and verified the c-ring to be deformed.The c-ring shows no other damage.The liner and c-ring were able to fully mate during a technician analysis with no issues and no damage was found on the liner where the c-ring seats to the liner.Device history record (dhr) 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.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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