(b)(4).Concomitant medical products: unknown liner; unknown head; unknown stem.(b)(6).Literature: h.B.Waterson, m.R.Whitehouse, n.V.Greidanus, d.S.Garbuz, b.A.Masri, c.P.Duncan."revision for adverse local tissue reaction following metal-on-polyethylene total hip arthroplasty is associated with a high risk of early major complications - (b)(6) 2018.Multiple mdr reports were filed for this event; please see associated reports: 0001822565-2018-05296 and 0001822565-2018-05298.It is unknown if product will be returning to zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
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