Model Number N/A |
Device Problem
Device Dislodged or Dislocated (2923)
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Patient Problem
Joint Dislocation (2374)
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Event Date 08/12/2023 |
Event Type
Injury
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Event Description
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It was reported that the patient underwent a revision procedure 26 days post implantation due to a dislocation of the liner from the head that resulted in the stem dislodging out of the canal half-way.There is no additional information available at the time of this report.
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Manufacturer Narrative
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(b)(4).G2: foreign: australia.D10: 802203602 zb 12/14 cocr hd 36mm x +0 lot # 2994139.00811400210 femoral stem 12/14 neck taper ext.Offset size 2 130 mm stem length lot # 65710648.110010244 g7 osseoti 3 hole shell lot # 7506421.The device will not be returned for analysis as it¿s location is not known; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch will be submitted.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: d4: expiration date and udi no product was returned or pictures provided; visual and dimensional evaluations could not be performed.A review of the device history records identified no deviations or anomalies during manufacturing.Medical records/radiographs were provided and reviewed by a health care professional.A review of the available records identified findings of the reported issues: impressions: left total hip arthroplasty with superior and likely posterior dislocation.Incomplete implementation of the femoral component within the proximal femur.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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Event Description
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There is no update to the prior event description provided.
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Search Alerts/Recalls
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