(b)(4).Concomitant medical products: medical product: oxford ph3 cementless fem sz m, catalog #: 154926, lot #: 6171639, medical product: oxf uni cmntls tib sz c rm size 4 pma, catalog #: 166575, lot #: 6187657.Report source, foreign - event occurred in (b)(6).Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2019-00010, 3002806535-2017-00009.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
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It was reported that a patient underwent an initial right knee replacement procedure.Subsequently, the patient was revised due bearing dislocation.The patient had been walking with the dislocation for 3 months.When the surgeon opened the knee, metallosis was present in the soft tissue.
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It was reported that a patient underwent an initial right knee replacement procedure.Subsequently, the patient was revised due bearing dislocation.The patient had been walking with the dislocation for 3 months.When the surgeon opened the knee, metallosis was present in the soft tissue.
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