(b)(4).Concomitant medical products: oxf twin peg cmntls fmrl md item#161474 lot#2503468; oxford cementless tibia d lm item#us166576 lot#3050476.Investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0009613350-2022-00571; 3002806535-2022-00455.
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It was reported in a clinical study that seven years after initial knee arthroplasty, a patient experienced severe pain and increased swelling in the knee.An aspiration of the joint was performed (results not provided).Cortisone injections were given which provided about 2-3 weeks of pain relief.Additionally, an injection of platelet rich plasma was also given.No revision has been noted to date.Due diligence is in progress for this event; to date no further information has been provided.
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(b)(4).No product was returned, or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.Device is used for treatment.The reported product was reviewed for compatibility with no issues noted.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: no obvious radiographic abnormality detected in either the unicompartmental knee arthroplasties which are placed on the medial compartments.The hardware appears intact without periprosthetic lucencies.Bones appear intact without radiographic abnormality.No joint effusion of the left knee.Soft tissues appear unremarkable.Overall fit, alignment, and bone quality appear normal.No signs of loosening, wear, radiolucency, or other contributing factors can be identified radiographically.No anatomical or implant complications detected radiographically.A definitive root cause cannot be determined.No corrective actions, preventive actions, or field actions resulted after investigation of this event.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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