(b)(4).Concomitant medical products: ref 211258, lot 314970 modular stem 9x75mm.Ref 211278, lot 672550 super eas humeral head 48x19mm.Ref 211228, lot 216410 regenerex augment small.Ref 211223, lot 484220 proximal body 71mm.Ref b000-0185, lot 6m9704 stryker universal cement restrictor.Ref 6197-1-001, lot tmz046 antibiotic simplex p qty: 2.Report source: foreign country: (b)(6).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2019-02522, 0001825034-2019-02523, 0001825034-2019-02524, 0001825034-2019-02525.Device evaluated by mfr: implanted.
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