(b)(4).Concomitant medical products: ref 211226, lot 938550, intercalary segment 90mm.Ref 211258, lot 314970, modular stem 9x75mm.Ref 211278, lot 672550, super eas humeral head 48x19mm.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 0001825034-2019-02524 0001825034-2019-02525 0001825034-2019-02526.Device evaluated by mfr: implanted.
|