CABLE READY GTR COCR CABLE

Description of Event or Problem

It was reported that the patient underwent a knee surgery and subsequently passed away in the following days of the procedure, on an unknown date, due to unknown medical complications.Attempts have been made and no further information has been provided.

Additional Manufacturer Narrative

(b)(4).D10: Item # 00801102032, ALLEN PLUG HDPE/BASO4 16C/32FL, Lot # 65725543.Item # 00801102032, ALLEN PLUG HDPE/BASO4 16C/32FL, Lot # 66528224.Item # 00585004603, SEGMENT WITH MALE/FEMALE TAPER 30 MM LENGTH, Lot # 67753852.Item # 00585004603, SEGMENT WITH MALE/FEMALE TAPER 30 MM LENGTH, Lot # 67753852.Item # 00585003014, ARTICULAR SURFACE WITH SEGMENTAL HINGE POST SIZE C 14 MM HEIGHT, Lot # 66601091.Item # 00585204030, STEM COLLAR 30 MM O.D. FOR USE WITH 16 MM OR SMALLER DIAMETER SEGMENTAL STEMS, Lot # 67348514.Item # 00598801016, 16mm Diameter 100mm Length Straight Stem Extension Combined Length 145mm, Lot # 67638151.Item # 00585205014, FLUTED STEM EXTENSION STRAIGHT PRECOAT FOR CEMENTED USE ONLY 14 MM DIAMETER 130 MM LENGTH, Lot # 67740616.Item # 00585004604, Polyethylene Insert XT Size C Use With Distal Femoral XT Size C Use With XT Only, Lot # 67536093.Item # 00585001396, SEGMENT WITH MALE/FEMALE TAPER 40 MM LENGTH, Lot # 66018620.Item # 00588000500, Size 5 Precoat Cemented Tibial Component, Lot # 67243960.Item # 00585004301, Distal Femoral XT Component Size C Left Use With Polyethylene .Insert XT Size C Use With XT Only For Cemented Use Only in the U.S.A., Lot # 67524738.Item # 00223200418, CABLE CERCLAGE CABLE WITH CRIMP 1.8 MM DIA. 635 MM LENGTH, Lot # 67849377.G2: Foreign - Event occurred in Australia.The device will not be returned for analysis; however, an investigation of the reported event is in progress. Once the investigation is completed, a supplemental MedWatch 3500A will be submitted.