(b)(4).
Initial report.
Report source, foreign - event occurred in (b)(6).
We are waiting to hear whether the product is available to be returned to zimmer biomet for investigation.
Medical product: unknown cobalt chrome head, catalog: unknown, lot: unknown.
Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2020-00547.
The investigation is in process.
Once the investigation has been completed, a follow-up mdr will be submitted.
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The patient's legal counsel reported that the patient was implanted with an aura ii stem, a crco head and a magnum acetabulum on (b)(6) 2010.
Following this total hip arthroplasty, the patient suffered from pain, however, he got back to professional life.
On (b)(6) 2017, the patient fell and the prosthesis has decompensated.
It was therefore seen through x-ray that the patient suffered from bipolar geodic reaction following a release of ions by the prothesis.
Indeed, it was reported that the metal friction between the prothesis components has led to inflammatory granulomas with a phenomen of bone resorption.
On (b)(6) 2020, the patient underwent a revision surgery to remove the prothesis.
The delay observed between the fall on (b)(6) 2017 and the revision surgery can be explained by the implantation of a total hip prothesis on the left hip.
This report is based on allegations set forth in patients notice and the allegations there in are unverified.
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