Model Number N/A |
Device Problem
Fitting Problem (2183)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 06/10/2019 |
Event Type
Injury
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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 supplemental mdr will be submitted.Concomitant medical products: medical product: cer bioloxd option catalog #: 650-1058 lot #: 2957980.Mdr reports were filed for this event, please see associated reports: 3002806535-2019-00536.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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It was reported by the hospital that during a hip replacement procedure, the implant would not assemble with mating implant.Subsequently, another product was used to complete the procedure.
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Manufacturer Narrative
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(b)(4).This follow-up report is being submitted to relay additional information.Following visual, dimensional and assembly checks of the returned items, no discrepancies have been identified, therefore the reported event has not been confirmed.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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Event Description
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It was reported by the hospital that during a hip replacement procedure, the implant would not assemble with mating implant.Subsequently, another product was used to complete the procedure.
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Search Alerts/Recalls
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