(b)(4).Combined initial/final report.This complaint was originally based on a 28mm ceramic head produced in usa so all previous reports were filed by the us zb team.Now the product has been identified as a 36mm, which is produced in (b)(6), it is now under (b)(6) control.The product has already been returned to zimmer biomet.Associated products: medical product: cer option type 1 tpr sleve +3, catalogue number: 650-1067, lot number: unknown.Complaint summary: investigation reopened as the product has now been returned.A visual inspection of the returned product shows this ceramic head to be a 36mm and not a 28mm as reported in the complaint, the ceramtec # is r36.The head shows signs of metal transfer on its surface indicating that articulation has taken place, most likely against the surface of the shell.There is also damage to the edge of the tapered adapter most likely caused whilst removing during the revision.Ceramtec coc review-: the component properties and the microstructure as obtained from the quality documents fulfil the requirements as specified at the time of production.There is no indication of any pre-existing material defect.A review of complaint history identified an additional 1 similar complaint about the reported item 650-1057 (lot number unconfirmed).Unable to perform complaint history for unknown shell as item/lot number is unknown.It has been confirmed that implant 650-1057 is not within the scope or subject of any field actions or recalls which could be attributed to the reported events.The likely condition of the devices when they left zimmer biomet is conforming to the specification.The reported event has not been confirmed.The root cause of the reported event cannot be determined with the information provided.No corrective actions, preventive actions, or field actions resulted after the investigation of this event.Multiple mdr reports were filed for this event previously, please see associated report numbers: 0001825034-2019-01678, 0001825034-2019-01678-1, 0001825034-2019-01678-2.If any additional information is discovered or received that may adjust any conclusions or data, a supplemental report will be rendered accordingly and the complaint reopened.Zimmer biomet will continue to monitor for trends.
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It was reported, that: a patient¿s legal counsel reported that the patient underwent left total hip arthroplasty on (b)(6) 2017.Legal counsel further reports patient underwent a revision procedure on (b)(6) 2018, due to dislocation and failed hip.This report is based on allegations set forth in plaintiff¿s complaint, and the allegations contained therein are unverified.
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