Model Number N/A |
Device Problems
Biocompatibility (2886); Device Dislodged or Dislocated (2923); Patient Device Interaction Problem (4001)
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Patient Problems
Pain (1994); Scar Tissue (2060); Synovitis (2094); Joint Dislocation (2374); Inadequate Osseointegration (2646); Metal Related Pathology (4530)
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Event Date 09/26/2023 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).D10 - medical devices: unk bearing biomet oxford left medial anatomic, 6mm; item# unknown; lot# unknown unk tibia biomet oxford medial cementless sz.D; item# unknown; lot# unknown h3 - product was discarded multiple mdr reports were filed for this event, please see associated reports: 3002806535 - 2023 - 00354 3002806535 - 2023 - 00355 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.H3 other text : product is unknown.
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Event Description
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It was reported that the patient had undergone a left unicompartmental knee arthroplasty.Subsequently, the patient experienced dislocation of the bearing and had a recurrent episode of dislocation.Approximately four years later, the patient underwent revision surgery due to pain and recurrent dislocations.During the procedure, significant synovitis with a metallosis appearance and scarring on the anterior flange were encountered.Initially, the surgeon had planned a poly swap, but this resulted in a conversion to a total knee arthroplasty.While trialing the bearing, the femoral component popped off due to a lack of ingrowth.All components, except for the tibial component, were revised without complications.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).Upon reassessment of the reported event, it was determined a medwatch report should not have been filed under the current manufacturer as the complaint is a duplicate of (b)(4)- mdr report number 3002806535-2023-00352.Given this information, this medwatch will be voided.
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Event Description
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Upon reassessment of the reported event, it was determined a medwatch report should not have been filed under the current manufacturer as the complaint is a duplicate of (b)(4) - mdr report number 3002806535-2023-00352.Given this information, this medwatch will be voided.
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Search Alerts/Recalls
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