It was reported that a patient underwent a right hip revision approximately nine years post implantation due to chronic instability.During the procedure, it was confirmed that the patients hip joint easily dislocated.There was also extensive necrotic bone and tissue that required debulking and debridement.Fluid accumulation, corrosion, muscle damage and a large pseudotumor were found.The head and liner were removed and replaced without further complication.
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(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0002648920-2022-00150, 0002648920-2023-00149.D10: cat #: 00630505036, liner standard 3.5 mm offset 36 mm i.D.For use with 50/52/54 mm o.D.Shells, lot #: 61354997; cat #: 00801803602, femoral head sterile product do not resterilize 12/14 taper, lot #: 61401792.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.
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