Catalog Number 010000927 |
Device Problem
Difficult to Insert (1316)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/23/2023 |
Event Type
malfunction
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Event Description
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It was reported that during the procedure, the liner would not assemble with the shell.Another liner was used to complete the procedure.There was no impact or health consequences to the patient.It was reported that no further information is available.
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Manufacturer Narrative
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(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2023-02616.D10: cat #: 010000663 / g7 pps ltd acet shell 52e / lot #: 7440497.G2: poland.Product has been received by zimmer biomet and 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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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.Visual examination of the returned product identified their liner locking feature has been deformed and shaved.There is no visible damage to the shell.It is unknown if the damage occurred prior to or during the assembly attempts.Complaint 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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