Catalog Number 11-165208 |
Device Problems
Difficult to Insert (1316); Material Twisted/Bent (2981)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/12/2023 |
Event Type
malfunction
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Event Description
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It was reported that the locking ring was bent and thus unable to be assembled with the liner at the time of use.There was no harm or health consequences to the patient.Attempts have been made and no further information is available.
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Manufacturer Narrative
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(b)(4).G2: (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.
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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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(b)(4), this follow-up report is being submitted to relay additional information.The following sections were updated/corrected.Visual examination of the returned product identified the locking ring was installed with the chamfer in the correct position and was bent.The returned liner had damage to the outer surface.The width and thickness of the locking ring were checked and found in conformance with the print.The complaint is confirmed based on the evaluation of the returned product.Dhr was reviewed and no discrepancies related to the reported event were found.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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Search Alerts/Recalls
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