It was reported that the patient had a hemiarthroplasty on (b)(6) 2021.The surgeon stated that he fell a few days after and dislocated, the patient has parkinson¿s.The surgeon elected to reduce and change the bipolar head on (b)(6) 2021.The patient was placed in a brace to stabilize the leg but the surgeon said he wasn¿t wearing it consistently.The surgeon said he fell again around the end of september and that he believed the patient to possibly be infected.The surgeon elected to remove all the implants and leave the patient with a girdle stone and tey to clear the infection.Doi: (b)(6) 2021 (stem), (b)(6) 2021 (bipolar head and femoral head).Dor: (b)(6) 2021.Affected side: right hip.
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Product complaint # = > (b)(4) investigation summary = > no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed, and the investigation will be re-opened as necessary.Device history lot = > the product investigation found no evidence suspecting an error in the material, manufacturing, inspection or sterile processing that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.
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