(b)(4).Multiple mdr's were submitted for this event.Please see associated reports: 3002806535 - 2018 - 00712; 3002806535 - 2018 - 00713; 3002806535 - 2018 - 00714.Concomitant medical products: unknown part/lot: taper, bearing, cup, stem.Report source: foreign.The event(s) occurred in (b)(6).Report source: literature.Borgwardt, arne, et al.¿a randomized seven-year study on performance of the stemmed metal m2a-magnum and ceramic c2a-taper, and the resurfacing recap hip implants.¿ the journal of arthroplasty, 2017, doi:10.1016/j.Arth.2017.11.061.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Device not returned to manufacturer.
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