Catalog Number UNKNOWN |
Device Problems
Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993); Loosening of Implant Not Related to Bone-Ingrowth (4002)
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Patient Problems
Failure of Implant (1924); Joint Dislocation (2374)
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Event Date 03/08/2023 |
Event Type
Injury
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Event Description
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It was reported that the patient underwent a partial knee replacement at an unknown date.Subsequently, after 18 years, the patient underwent revision surgery for unknown reasons.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).Report source-foreign-australia.Device evaluated by mfr: device evaluation could not be performed as part# and lot# unknown.Multiple mdr reports were filed for this event, please see associated reports: 3002806535 -2023 -00088, 3002806535 -2023 -00090.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 3500a will be submitted.
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Manufacturer Narrative
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(b)(4).D10: item#: unknown; :lot#: unknown; item name: unknown oxford tibial component.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 manufacturing records cannot be performed without product identification.Device is used for treatment.Medical records were not provided.With the available information, 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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It was reported that the patient underwent revision surgery due to dislocation and loosening of the femoral component.
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Search Alerts/Recalls
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