ZIMMER GMBH BIOLOX® DELTA, CERAMIC FEMORAL HEAD, S, ø 36/-3.5, TAPER 12/14; HIP IMPLANT
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Model Number N/A |
Device Problem
Device Dislodged or Dislocated (2923)
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Patient Problem
Subluxation (4525)
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Event Date 11/01/2023 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).D10: allofit alloclassic shl 52/ii item # 00000004245 lot #3067706 avenir muller stem 4 standard item # 01.06010.004 lot # 3131823 g2: foreign: australia the device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch will be submitted.Multiple mdr reports were filed for this event, please see associated reports 0009613350 -2023 -00618.
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Event Description
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It was reported that the patient reported subluxation of hip.Hip was revised and femoral head was replaced with an increased offset.Due diligence is in progress for this complaint; to date no additional information or product has been received.
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Manufacturer Narrative
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(b)(4) this follow-up report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.A review of the device manufacturing records confirmed no abnormalities or deviations that could be related to the reported event.The reported products were reviewed for compatibility with no issues noted.Review of the complaint histories found no additional related complaints for these item/s and the reported part and lot combinations.With the available information, a definitive root cause could not 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 additional information at this time.
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Search Alerts/Recalls
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