Clinical notification received for revision of right total hip to address dislocation.Primary operative notes (b)(6) 2010 indicate the patient received a right total hip replacement due to end stage osteoarthritis.The surgery was completed without indication of complication by the surgeon.Office notes (b)(6) 2021 indicate the patient is experiencing pain, swelling, stiffness and episodes of subluxation in her right hip.Revision operative notes (b)(6) 2021 indicate the patient received a right total hip revision due to adverse reaction to metal debris, pain, osteolysis and avascular facia soft tissue.Intra-op findings include bone loss, and fracture of the tip of the trochanter.It was noted that the metal liner was cold-welded to the acetabular shell and unable to be removed ¿ therefore, the entire cup was removed.The stem was well fixed and retained.The surgery was completed without indication of complication by the surgeon.There is no mention of a hip dislocation beyond the episodes of subluxation noted in office notes.Date of implantation: (b)(6) 2010; date of revision: (b)(6) 2021; (right hip).Treatment: revision of cup, hole eliminator, liner, and head.
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Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.All available x-rays were reviewed, and no evidence of implant fracture, disassociation, or anything indicative of a device nonconformance was found.The x-rays provided as evidence were taken post revision, so from an investigation standpoint is impossible to link the allegation against the device with the evidence provided.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Device history lot : the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.
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