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Model Number N/A |
Device Problem
Patient Device Interaction Problem (4001)
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Patient Problems
Pain (1994); Loss of Range of Motion (2032); Local Reaction (2035); Metal Related Pathology (4530)
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Event Date 11/12/2021 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Concomitant medical products: 141490 - offset tib tray adaptor - 752210, 184764 - series a pat std - 674220, 141658 - bmt splined knee stm - 082360, 141483- biomet offset tibial tray - 154000, 183880 - vngd ssk psc tib brg - 740600, 141616 - bmt splined knee stem - 901020, 110035368 - biomet bc r 1x40 us - 743cah1407, and 110035368 - biomet bc r 1x40 us - 826aac2203.The customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product location is unknown.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: 0001825034-2022-00141, 0001825034-2022-00144 ,0001825034-2022-00145, 0001825034-2022-00146, and 0001825034-2022-00147.
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Event Description
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It was reported that the patient underwent a revision surgery approximately 2.5 years post implantation due to pain, loosening, metal debris, and limited mobility.During the revision, blackened synovium with metal debris was noted.The femur, tibia, tibia adapter, stems, and bearing were exchanged without complications.The patella remained intact.Attempts have been made and no further information has been provided.
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Event Description
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This follow-up report is being submitted to relay additional information.
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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; g3; g6; h1; h2; h3; h6; h10 h6: 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 were provided and reviewed by a health care professional.Review found patient presented with left knee pain.X-ray review found loosening.During the revision procedure blackened synovium was found in the joint space due to metal debris.The tibial tray was loose with motion between the tray and the morse taper for the stem (disassociation would have occurred between the offset adapter and stem).X-rays were provided and reviewed by a health care professional.Review found possible metallosis noted within the posterior joint space.Overall fit and alignment of the implants is appropriate.Normal bone quality.No signs of radiolucency.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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