MAUDE Adverse Event Report: Zimmer Biomet, Inc. CABLE READY GTR COCR CABLE; Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component

Catalog Number	00223200418
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Death
Event or Problem Description
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.

• Brand Name: CABLE READY GTR COCR CABLE
• Common Device Name: Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
• Manufacturer (Section D): Zimmer Biomet, Inc.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): Zimmer Biomet, Inc.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; +1(574)526-0384
• MDR Report Key: 50019159
• Report Number: 0001822565-2026-02676
• Device Sequence Number: 13406539
• Product Code: KTT
• UDI-Device Identifier: 00889024039513
• UDI-Public: (01)00889024039513(17)360428(10)67849377
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K151907
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/24/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 00223200418
• Device Lot Number: 67849377
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/28/2026
• Initial Report FDA Received Date: 07/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/01/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: See H11 narrative.
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Female