Model Number N/A |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Erosion (1750); Pain (1994); Scar Tissue (2060)
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Event Date 12/03/2009 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).D10: 183030 - vanguard cr ilok fem-lt 67.5 - 937520; 141233 - biomet cc cruciate tray 71mm - 093040; 11-150842 - bmet arcom ap pat 3pst 34mm md - 171810; 402433 - cobalt-g hv bone cement 40gm b - 952700.Customer has indicated that the product will not be returned to zimmer biomet for investigation.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: 0001825034-2023-02864; 0001825034-2023-02865.
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Event Description
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It was reported that a patient had an initial left total knee arthroplasty.Subsequently 1.5 years later, the patient had experienced pain and recurrent effusions since the initial surgery and the patient underwent a revision.They found synovium inflamed which was consistent with the recurrent effusions and stress shielding behind the tibial and femoral components.A complete synovectomy was performed, inflamed hypertrophic scar tissue was excised, and all implants, except the patella, were revised without complication.Attempts have been made and all available information has been provided.
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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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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.The following sections were updated: b4; b5; d2; g1; g3; g6; h1; h2; h3; h4; h6 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: no intra-operative complication noted during initial and revision surgeries.On revision op note states that the patient had effusion and pain.Bone scan demonstrated quite a bit of uptake around femoral component and increased amount during the blood flow phase.No obvious signs of loosening, inflammatory synovium consistent with recurrent effusions.Surgeon noted that ''behind the tibial and femur had some evidence of stress shielding and it was better than anticipated and was similar to the type we would see behind the press-fit device'' and removed scar tissues.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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Search Alerts/Recalls
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