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 03/15/2019 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4) report source: (b)(6).Concomitant medical products: unknown head, unknown.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.
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Event Description
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It was reported that during initial hip procedure, the 28mm head could not be put into the liner.No additional information available.
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Manufacturer Narrative
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Complaint sample was evaluated and the reported event was confirmed.Review of the lock ring upon removal from the liner showed the taper feature that goes around the entire ring is not present.Due to the evaluation of the returned unit of the complaint, it was confirmed the missing chamfer feature which was attributed to excess of accumulated chips on the tool that performs the cut.Dhr was reviewed and no discrepancies were found.Root cause is determined to be manufacturing deficiency.No additional actions are required as the appropriate controls were already in place during the time of manufacturing.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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