(b)(4).Multiple mdrs were filed for this event.Please see associated: 0001825034-2019-04760, 0001825034-2019-04761, 0001825034-2019-04762, 0001825034-2019-04778, 0001825034-2019-04770, 0001825034-2019-04776, 0001825034-2019-04763, 0001825034-2019-04764, 0001825034-2019-04773, 0001825034-2019-04771, 0001825034-2019-04766, 0001825034-2019-04767, 0001825034-2019-04772, 0001825034-2019-04768, 0001825034-2019-04774, 0001825034-2019-04775 concomitant medical products: 11-162115, reach 15x250 lt 100% por fmrl, 251140, 11-104955, mlry-hd cal w/hole 34x17x220 r, 275470r, 12-162584, bi-met co-cr hd/nk 13x34x250 r, 413690, 12-162485, bi-met co-cr hd/nk 13x45x200, 682040, 12-162484, bi-met co-cr hd/nk 11x45x200, 179580, 11-162117, reach 17x250 lt 100% por fmrl, 441120, 12-162596, bi-met co-cr hd/nk 13x55x250 r, 808630, 12-162485, bi-met co-cr hd/nk 13x45x200, 703910, 12-162574, bi-met co-cr hd/nk 15x34x250 r, 046710, 12-162588, bi-met co-cr hd/nk 11x45x250 r, 821500, 12-162489, bi-met co-cr hd/nk 15x34x200, 627880, 12-162490, bi-met co-cr hd/nk 15x45x200, 307010, 180221, balance microp stem 17x80mm lt, 193920, 12-162485, bi-met co-cr hd/nk 13x45x200, 314510, 11-104973, mlry-hd cal w/hole 45x17x220 r, 066930, 12-162481, bi-met co-cr hd/nk 11x34x200, 009370.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
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