(b)(4).Journal article: waterson, h.B., whitehouse, m.R., greidanus, n.V., garbuz, d.S., masri, b.Z., duncan, c.P.(2018).Revision for adverse local tissue reaction following metal-on-polyethylene total hip arthroplasty is associated with a high risk of early major complications.The british editorial society of bone & joint surgery.100-b:720¿4.Https://doi.Org/10.1302/0301-620x.100b6.Bjj- 2017-1466.R1.Concomitant medical products: item# unknown, unknown stem, lot# unknown; item# unknown, unknown liner, lot# unknown; item# unknown, unknown cup, lot# unknown.Foreign source: (b)(6).Multiple mdr reports were filed for this event; please see associated reports: 0001822565-2018-05209.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
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It was reported in journal article that nine patients presented with elevated metal ions preoperatively.Patient proceeded with revision of tha.During the procedure the joint was found to have developed armd, confirmed by intraoperative pathology samples which revealed necrotic granulomatous and trunnionosis that was identified by visible thick black debris on the trunnion.Attempts were made to obtain additional information; however, none was available.
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