(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation.Medical product: oxf uni tib tray sz c rm pma, catalog #: 154723, lot #: 2423675.Medical product: oxf anat brg rt sm size 3 pma, catalog #: 159568, lot #: 129880.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2020-00291, 3002806535-2020-00292.Reporter occupation: clinical knee admin.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
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(b)(4).This final report is being submitted to relay additional information.Multiple mdr reports were filed for this event: 3002806535-2020-00291-1, 3002806535-2020-00292-1.As the product has not been received, the investigation was limited to the information provided.Radiographs: fourteen radiographs were provided for analysis with (b)(4), one anteroposterior (ap) and one mediolateral (ml) for each follow-up visit at 6 weeks, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years.Only radiographs showing the right knee (associated with complaint (b)(4)) have been assessed.All provided radiographs of the right knee show adequately sized and positioned components of the oxford partial knee system.At the pre-operative visit ((b)(6) 2014), the patient presented weight of 72.6 kg and a height of 1.63 m, thus having a bmi of 27.33 (overweight).The kss and oxford assessment scores were excellent at post-operative visits, except from a slightly lower oxford knee score of 36 at the 3-year postoperative visit ((b)(6) 2017).It is to be noted that the patient reported an adverse event, described as patient fell on right knee about a month ago, she has mild posterior knee pain and weakness after the fall, about a month before this visit (date of onset (b)(6) 2017).Therefore, this adverse event may have contributed to the observed lower oxford knee score.Moreover, this adverse event was marked as not related to the device by the physician, and the event was recorded as tolerated with no treatment.Based on the radiographs provided with (b)(4) and on the information reported in the case report form (crf), it is concluded that the reported patient death is unrelated to the oxford knee system associated with the complaint.The manufacturing history records (mhrs) for the oxford anatomic bearing, tibial tray and femoral component have been checked and verify that the parts were manufactured and sterilised in accordance with the applicable specifications, and no abnormalities or deviations reported.Without the opportunity to examine the complaint product, root cause cannot be determined due to insufficient information.Risk assessment: the details of the reported event conclude that the reported death of the patient is unrelated to the device.Therefore, risk assessment cannot be conducted with the information provided.No corrective or preventive actions are deemed necessary at this time.If any additional information becomes available, then the complaint will be reopened and investigated thoroughly.H3 other text : product has not been returned.
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