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 -00089.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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Event Description
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Upon review of this complaint from an investigation perspective, it is considered that the unknown tibial component within this complaint does not impact the reported event of dislocation and loosening of the femoral component.
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Manufacturer Narrative
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(b)(4).Upon review of this complaint from an investigation perspective, it is considered that the unknown tibial component within this complaint does not impact the reported event of dislocation and loosening of the femoral component.Given the above information, this product will now be considered an associated item.
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Search Alerts/Recalls
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