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(b)(4).Initial report: customer has indicated that the product will not be returned to zimmer biomet for investigation, as it remains implanted.Medical product: oxf twin peg cmntls fmrl sm, catalog #: 161473, lot #: 2407036; medical product: oxford cementless tibia b lm, catalog #: 166572, lot #: 3050457.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2020-00387, 3002806535-2020-00388.Occupation: clinical project lead.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Product has not been returned.
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(b)(4).This final report is being submitted to relay additional information.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2020-00387-1, 3002806535-2020-00388-1.As the product has not been received, the investigation was limited to the information provided; a review of device history records and complaint history.Radiographs: fourteen radiographs were provided with (b)(4) for analysis: one anteroposterior (ap) and one mediolateral (ml) per follow-up visit (6 weeks, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years).The tibial tray appears short of the medial edge of the tibial plateau in all ap x-rays.The oxford partial knee surgical technique states that the tibial tray should be flush with (or have less than 2 mm overhang from) the medial edge of the tibial plateau.The oxford partial knee components appear otherwise appropriately sized and positioned.The patient, a female, was 55 years old at the time of surgery to the left knee.With a height of 1.63 m and a weight of 90.7 kg, the patient had a bmi of 34.1 (obese) at the preoperative visit ((b)(6) 2014).From 6 months after surgery, the patient presented excellent knee society scores, as well as oxford knee scores indicating satisfactory joint function, not requiring any formal treatment, up until the 4-year post-operative follow-up.At the 5-year follow-up, the kss functional score was excellent, but the kss assessment score was poor and the oxford knee score was 34, potentially indicating a mild problem not requiring surgical intervention.It should be noted that the patient received a unicompartmental knee arthroplasty to the right knee on (b)(6) 2015, which led to some follow-up visits for the left oxford partial knee occurring outside the intended window (2 year, 4 year, 5 year).In (b)(6) 2020, and adverse event of swelling and pain on lateral aspect of knee was reported.It was uncertain whether it was related to the device, and it was tolerated without treatment.This suggests a possible case of progression of osteoarthritis to the lateral condyle.However, it is not possible to confirm this with the information available at the time of writing this report.The manufacturing history records (mhrs) for the oxford partial knee tibial tray, femoral component and anatomical bearing have been checked and verify that the components were manufactured and sterilised in accordance with the applicable specifications.A review of the complaint database over the last 3 years has found no similar complaints reported with item and lot combination.A review of the complaint database over the last 3 years has found 3 similar complaints with item 159540, 4 similar complaints with item 161473 and 3 similar complaints with item us166572.Trend identified as 2 similar complaints are with same lot 086670 and same hospital for item 159540, for item 161473, 2 similar complaints are with same lot r2409853a, 2 complaints with similar hospital and 2 complaints are with same doctor, for item us166572 2 similar complaints are with same lot r3050461a and same doctor and 2 complaints are from same hospital.Without the opportunity to examine the complaint product, root cause cannot be determined due to insufficient information.Risk assessment: the root cause of the issue could not be determined with the information currently available, therefore the specific failure cause within the risk tables could not be selected for comparison.For item: 159540 lot: 948190 risk management report documents the estimated residual risk associated with the reported event.The reported event states patient experienced swelling and pain.In the risk file, pain and swelling/edema is considered harm with a maximum severity level of 3 for a number of hazards defined as moderate, which as per the severity table listed within the rmr is defined as prescribed medical or surgical intervention to preclude permanent impairment of a body function or body structure.Contributed to minor, temporary, or medically reversible injury.For item: 161473 lot: 2407036 and item: us166572 lot: 3050457 risk management report documents the estimated residual risk associated with the reported event.The reported event states patient experienced swelling and pain.In the risk file, pain and swelling/edema is considered harm with a maximum severity level of 3 for a number of hazards defined as moderate, which as per the severity table listed within the rmr is defined as prescribed medical or surgical intervention to preclude permanent impairment of a body function or body structure.Contributed to minor, temporary, or medically reversible injury.Clinical study notes state no treatment has been given.The patient is currently tolerating the swelling and pain.The reported event is considered to be within the severity of the rmf.If further information regarding the root cause of the reported event is provided, risk should be re-assessed.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.
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