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 02/28/2023 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Concomitant medical products: 11-363662 36mm cocr mod hd std lot number: 064200.010000702 g7 bonemaster ltd acet shl 50d lot number: 7123585.010000856 g7 neutral e1 liner 36mm d lot number: 7244646.Report source: foreign: australia.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2023 - 00641.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, as supplemental medwatch will be submitted.
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Event Description
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It was reported pt underwent a revision procedure 3 months post-implantation due to dislocation.There is no additional information available at the time of this report.
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Manufacturer Narrative
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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.Review of the device history records identified no deviations or anomalies during manufacturing.Two images assess and not submitted to mmi as the event reports a single incident of dislocation which is not captured within the images.Operative notes from the revision were not provided.Review of the medical notes from the initial operation found no 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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