(b)(4), d10 - medical devices: unknown oxford femoral component; item# unknown; lot# unknown.Unknown oxford tibial component; item# unknown; lot# unknown.G2 - foreign: china.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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(b)(4).This follow-up report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.A review of the device manufacturing records confirmed no abnormalities or deviations that could be related to the reported event.Device is used for treatment.Radiographs were provided and reviewed by a radiologist.The review identified a medial compartment hemiarthroplasty with possible radiolucency along the femoral component on the two views of the left knee that were provided.Linear ossification along the medial aspect of the medial femoral condyle likely relates to patient's known mcl avulsion injury.Dislocated bearing within the suprapatellar bursa with associated metal on metal appearance within the medial compartment.Mild degenerative change of the lateral and patellofemoral compartments with moderate joint effusion.Medical records were provided and reviewed by a health care professional.The review identified an avulsion fracture of medial collateral ligament stop, injury to medial collateral ligament.Analysis and description of the cause of the incident: the patient's left knee medial collateral ligament insertion point was considered to have an avulsion fracture, local ligament laxity, and the medial compartment space enlarged, resulting in the meniscus spacer falling off.With the available information, a definitive root cause could not be determined.It is possible that the avulsion fracture and dislocation of the bearing are connected, however the exact sequence of events, or causative relationship among these factors cannot be definitely 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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