(b)(4).Additional concomitant medical products: unknown longevity liner ¿ unknown part and lot; unknown m/l taper ¿ unknown part and lot; unknown shell ¿ unknown part and lot.Therapy date: unknown.(b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation as the product location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.The reported event was identified during review of a journal article waterson, h.B., whitehouse, m.R., greidanus, n.V., garbuz, d.S., masri, b.A., & 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 bone & joint journal, 100-b, 720-724.Doi:10.1302/0301-620x.100b6.Bjj-2017-1466.
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