(b)(4).Concomitant medical products: unknown oxford tibial component; item#: unknown lot#: unknown.Unknown oxford femoral component; item#: unknown lot#: unknown.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2023-00071 and 3002806535-2023-00073 remains implanted.
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It was reported that the patient underwent a right oxford partial knee replacement and subsequently suffered reactions to it within three days post-operatively.Patient has experienced the following since the operation: bilateral hearing loss, vision loss, thyroid issues, muscle spasms, skin reactions, pain, fatigue, and swelling at the joint.Due diligence is in progress for this complaint; to date no additional information or product has been received.
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