(b)(4).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.Concomitant medical devices: 42538000401 - tibial component - 63755573; 42558000301 - femoral component - 64465213; 110034355 - refobacin bc r 1x40 us - 835aae2507.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2020-03212, 3007963827-2020-00221.
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It was reported that the patient underwent an initial left unilateral knee arthroplasty.Subsequently, the patient experienced a fall three weeks post op.Approximately 2 months post implantation, the patient was revised due to difficulty ambulating, decrease in activity of daily living, pain, swelling, radiolucency, a periprosthetic fracture, loosening, subsidence, and poor bone quality.
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