(b)(4).Report source: foreign- norway.Concomitant associated products: item number: unknown, item name: unknown ncb screw, lot number: unknown.Item number: unknown, item name: unknown ncb screw, lot number: unknown.Item number: unknown, item name: unknown ncb screw, lot number: unknown.Multiple mdr reports were filed for this event, please see associated report: 0009613350-2022-00487, 0009613350-2022-00488, 0009613350-2022-00490.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
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This follow-up report is being submitted to relay additional and/or corrected information.No product was returned, or pictures provided; visual and dimensional evaluations could not be performed.Part and lot identification are necessary for review of device history records, neither were provided.Devices are used for treatment.Complaint history review cannot be performed without product identification.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: three views of the distal left femur demonstrate a left total knee arthroplasty and lateral plate and screw fixation device with an oblique fracture involving the distal diaphysis of the femur.Vascular calcifications.Loosening of the distal femoral plate also seen.The lateral femoral plate has withdrawn with screws seen within the soft tissues.Oblique fracture of the distal femur suggests trauma.A definitive root cause cannot be determined.If any further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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