(b)(4).Multiple mdr reports were filed for this event, please see associated report: 0001822565-2019-01353, 0001822565-2019-01354.Concomitant medical products: partial tibial cemented size e right medial, item# 42538000502 , lot# 63807406; partial articular surface right medial, item# 42528200509, lot# 63435460.Customer has indicated that the product will not be returned to zimmer biomet for investigation as it remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
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Corrected: adverse event only.The reported event was confirmed through patient notes.No complications were noted in crf.Office visit note states that patient had moderate pain.Another office visit note states that patient had extreme pain, stiffness and difficulty in ambulation.The rom was noted to be 110 degrees.X-ray review by third party hcp states that slight rotation of the femoral component and slight subsidence of the tibial component occurred resulting in malalignment as described.Slight worsening in the medial patellofemoral joint arthrosis.There is also worsening of the contralateral left knee arthrosis.Device history record (dhr) was reviewed for deviations and/ or anomalies with no related deviations / anomalies identified.It was noticed in the x-ray evaluation that there is arthrosis seen in the knee which can be a contributing condition.However, a root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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