EXACTECH, INC. KNEE COMPONENT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED,
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Device Problem
Loss of or Failure to Bond (1068)
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Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 07/20/2022 |
Event Type
Injury
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Event Description
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It was reported via a legal notification, that a 77 yo male patient, who had an initial left knee implanted, date unknown, underwent a revision procedure on (b)(6) 2022, due to a failed left total knee replacement refractory to conservative management.Imaging was consistent with failed left knee arthroplasty.Operative notes indicate the femoral implant was grossly loose and manually removed with minimal bone loss.The tibia was removed with minimal bone loss.The devices were replaced with a competitors products.The patient was transferred to the recovery room in stable condition.No device return anticipated due to this being a legal case.No further information.
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Manufacturer Narrative
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Additional information, including the product investigation, will be submitted within 30 days of receipt.
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Manufacturer Narrative
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H10.Updated/additional information - d1, d4 (model no.- na and lot no.- na), d5, g3.H6.Investigation results - the revisions reported was likely the result of an insufficient bond between the femoral component and the bone and/or patient related conditions, which led to aseptic (non-infected) femoral loosening.However, this cannot be confirmed as the devices were not returned for evaluation, and no images or radiographs were provided.These devices are used for treatment not diagnosis.No other information available.
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Search Alerts/Recalls
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