The primary surgery was performed on (b)(6) 2011 via tha.It was reported that the patient complained pain from about 1 year ago and it had been progressing adduction of the stem during the follow-up observation.Thus, the revision surgery was performed on (b)(6) 2018 by replacing the insert (p/n: 121887356), the head (p/n: 962712000), the stem (p/n: 900527210) with sleeve (p/n: 550501).The cup (manufactured by (b)(4)) was not replaced, and two additional screws inserted.It was confirmed that adhesion of black powder at the head and the stem neck joint, degeneration of soft tissue, osteolysis of proximal part of femur.The stem and the sleeve were stuck together and did not separate when it was explanted.The surgery was completed without problems and there was no surgical delay.
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Product complaint : (b)(4).Investigation summary : no device associated with this report was received for examination.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.If information is obtained that was not available for the initial medwatch , a follow-up medwatch, will be filed as appropriate.
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