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Model Number N/A |
Device Problem
Unstable (1667)
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Patient Problems
Failure of Implant (1924); Pain (1994); Synovitis (2094); Burning Sensation (2146); Osteolysis (2377); Ambulation Difficulties (2544); Tissue Breakdown (2681); Joint Laxity (4526); Swelling/ Edema (4577)
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Event Date 10/11/2023 |
Event Type
Injury
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Event Description
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It was reported that the patient underwent an initial left total knee arthroplasty due to a work related injury resulting in bilateral knee posttraumatic arthritis.Since the initial procedure, the patient has complaint of ongoing and increasing pain, swelling, instability, limp, and heat in the joint.The patient has been recommended for revision surgery as recent x-rays suggest loosening.Subsequently, the patient was revised approximately 7 years post-op due to aseptic loosening.During the revision, the surgeon noted osteolysis to the tibia and femur, a large defect secondary to chronic loosening, and fibrous membrane formation.The tibia, femur, and articulating surface were exchanged with competitor products without complications.The patella remained implanted.Attempts have been made and all available information has been provided.
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Manufacturer Narrative
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(b)(4).D10: 00598005701 - stemmed tibial component precoat size 7 for cemented use only use of this tibial component with lcck articulating surfaces requires using a stem exten - 63283972.00596205110 - articular surface use with lps/lps-flex 51 or 52 suffix femorals size ef 10 mm height - 62994139.00111314001 - palacos rg 1x40 single - 84344539.00111314001 - palacos rg 1x40 single - 84344539.00597206538 - all poly patella standard cemented size 38 mm diameter 9.5 mm thickness - 62939856.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0002648920-2023-00316, 0001822565-2023-00378, 0001822565-2023-03753, 0001822565-2023-03756.
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Manufacturer Narrative
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His follow-up report is being submitted to relay additional information.H6 : suggested component code: mechanical (g04) - femur.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.The device history record was reviewed and no discrepancies relevant to the reported event were found.Medical records/radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: boggy effusion or synovitis, evolving periprosthetic lucency surrounding the tibial stem, consistent with loosening, potential crack within the tibial cement, cortical defect/osteolysis noted in the medial femoral condyle, potential subsidence of the tibial stem, osteolysis of the femoral condyle, large central cavitary defect in the tibial metaphysis, fibrous membrane formation.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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Event Description
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No further event information available at the time of this report.
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Search Alerts/Recalls
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