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Device Problems
Loosening of Implant Not Related to Bone-Ingrowth (4002); Migration (4003)
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Patient Problems
Failure of Implant (1924); Scar Tissue (2060); Synovitis (2094); Osteolysis (2377); Osteopenia/ Osteoporosis (2651)
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Event Date 09/29/2020 |
Event Type
Injury
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Event Description
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It was reported via a clinical study that a patient had a right total knee arthroplasty.Subsequently, approximately eleven (11) years post-implantation, the patient underwent revision surgery due to femoral loosening, subsidence, and bone loss.All components were revised.Due diligence is in process for this complaint; to date no further information has been provided.
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Manufacturer Narrative
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(b)(4).Concomitant medical products: unknown tibial tray: catalog#ni, lot#ni; unknown articular surface: catalog#ni, lot#ni.Customer has indicated that product will not be returned to zimmer biomet for investigation, as the product location is unknown.The investigation is in process.Upon receipt of additional information or completion of the investigation, a follow-up mdr will be submitted.
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Event Description
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It was reported via a clinical study that a patient had a right total knee arthroplasty.Subsequently, approximately eleven (11) years post-implantation, the patient underwent revision surgery due to femoral loosening, subsidence, and bone loss.During the revision, scar tissue, synovitis, osteolysis and articular surface implant fracture were noted.All components were revised.It was reported that no further information is available.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.D10: medical product: unknown nexgen tibial tray size 8: catalog#ni, lot#ni; unknown nexgen articular surface 10mm: catalog#ni, lot#ni; unknown patella component size 41: catalog#ni, lot#ni; unknown bone cement: catalog#ni, lot#ni.An additional mdr report has been filed for this event.Please see additional associated report: 0001822565-2022-03539.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
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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.H6: proposed component (annex g) code is mechanical (g04) - femur.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.The device history record was unable to be performed as the lot number of the device involved in the event is unknown.Medical records/radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: the x-ray review found subsidence in zone 10- 20mm, bone loss zone 10- 20mm and femoral loosening.Revision was performed.During the surgery, femur was loose with massive distal femoral bone loss and osteolysis.Significant scar tissue formation throughout the joint.No sign of infection.Tibial and patella intact, however, tibial post was fractured.Tibia excised with some medial tibia plateau bone loss and osteolysis, but bone stock was maintained.When placing trials noted distal femur fracture, repaired with cerclage cables.Final implant was implanted without no complication.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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