(b)(4).Concomitant medical products: vanguard ssk femur catalog # 185283 lot # 3458069, vanguard distal femur augument catalog # 185383 lot # 761510, vanguard distal femur augument catalog # 185403 lot # 960320, vg 360 univ pst fm aug catalog # 185343 lot # 144500, vg 360 univ pst fm aug catalog # 185343 lot # 917410, bmt splined knee stm catalog # 148316 lot # 070820, bmt offset adapter catalog # 185210 lot # 461680, bmt tib tray catalog # 185203 lot # 354030, bmt splined knee stm catalog # 148318 lot # 601210, bmt tib aug catalog # 185233 lot # 754180, vngd ssk psc tib brg catalog # 183890 lot # 840400.H3: customer has indicated that the product will not be returned because it remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filled for this event: 0001825034-2019-05413, 0001825034-2019-05414, 0001825034-2019-05420, 0001825034-2019-05421, 0001825034-2019-05423, 0001825034-2019-05424, 0001825034-2019-05425, 0001825034-2019-05426, 0001825034-2019-05427, 0001825034-2019-05429, 0001825034-2019-05430.Remains implanted.
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It was reported that the patient underwent a revision knee arthroplasty due to infection.Subsequently, the patient experienced tingling and numbness in the knee two weeks postoperatively.The patient was diagnosed with peripheral neuropathic pain treated with gabapentin, physical therapy and sleep medication.Within the postop follow up visits, the patient reported decreasing ambulation, increased pain, and the need for assistive device to ambulate.
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