ZIMMER SWITZERLAND MANUFACTURING GMBH BIOLOX® DELTA, CERAMIC FEMORAL HEAD, L, 32/+3.5, TAPER 12/14; BIOLOX DELTA CERAMIC FEMORAL HEAD
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Model Number N/A |
Device Problem
Human-Device Interface Problem (2949)
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Patient Problem
Joint Dislocation (2374)
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Event Date 03/30/2022 |
Event Type
Injury
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Event Description
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It was reported that: total hip replacement on right hip done in (b)(6) hospital.Reason for revision is dislocation.Patient involvement-revision.
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Manufacturer Narrative
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Concomitant medical products: medical product: avenir® müller, stem, lateral, uncemented, ha, 4, taper 12/14 catalog#: 01.06010.104; lot#: 2893093.32mm i.D.Size ii elevated rim liner use with 52mm o.D.Size ii shell catalog#: 00-8752-010-32 ; lot#: 63648275.52mm o.D.Size ii porous uncemented with cluster holes shell use with ii liners catalog#: 00-8757-052-01; lot#: 63719117.X-ray received and will be reviewed as part of ongoing investigation.The manufacturer did not receive the device for investigation.The lot number of the device was received.The device history records will be reviewed during investigation.A cause for this specific event cannot be ascertained from the information provided.As soon as supplemental information becomes available an updated report will be submitted.Zimmer biomet¿s reference number of this file is (b)(4).Discarded.
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Manufacturer Narrative
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(b)(4).This follow-up report is being submitted to relay additional information.As no product was returned, visual and dimensional evaluations could not be performed.A review of the device history records did not identify any discrepancies that would have contributed to the reported event.Device is used for treatment.There are no recalls or product holds for the reported product.Medical records were not provided and the radiograph does not confirm reported event.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report 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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