MAUDE Adverse Event Report: ZIMMER BIOMET, INC. CABLE-READY CABLE GRIP SYSTEM CABLE FOR DISTAL END PLATE; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION

Catalog Number	00223200518
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Aseptic loosening (4883)
Date of Event	06/20/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: item# 00223200206; lot# 65704811.Item# 02.03150.040; lot# unknown.G2: foreign - event occurred in australia.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product was discarded.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.If any further information which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
It was reported that the patient underwent a primary surgery approximately one (1) year and three (3) months ago to receive a hip arthroplasty and a cable ready gtr plate and cables.When the case was done, there was a non-zb bone graft put in between the cable ready plate and the hip stem.Subsequently, the graft did not take which caused the plate and cables to become loose.The patient underwent a reoperation approximately three (3) weeks ago to remove the plate and cables.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected: b4; b5; d2; g1; g3; g6; h1; h2; h3; h6.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Medical records/radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: bony deficiency lateral to the femoral component proximally and radiolucency at mid-distal femoral stem are noted.The femoral stem is grossly neutral within the femoral shaft.The proximal 2 cables are disrupted with metal fraying of the cables.Generalized osteoporosis is noted, a possible risk factor for graft failure, femoral component loosening and loosening of metal cables.Review of the device history record(s) identified no deviations or anomalies during manufacturing.It was reported that a non-zb bone graft was put in between the cable ready plate and the hip stem which did not take and potentially contributed to the failure of the implant structure.Additionally, review of the provided x-rays noted disrupted cables and risk factors for graft failure.As multiple contributing factors are present, a definitive root cause cannot be determined.The event was confirmed.If any further information which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: CABLE-READY CABLE GRIP SYSTEM CABLE FOR DISTAL END PLATE
• Common Device Name: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION
• 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 ; 5745260384
• MDR Report Key: 22480275
• Report Number: 0001822565-2025-02473
• Device Sequence Number: 20970937
• Product Code: KTT
• UDI-Device Identifier: 00889024039537
• UDI-Public: (01)00889024039537(17)321125(10)65624123
• 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: 2024
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/31/2025

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?: Yes
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 00223200518
• Device Lot Number: 65624123
• 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: 06/20/2025
• Supplement Date Received by Manufacturer: 12/31/2025
• Initial Report FDA Received Date: 07/11/2025
• Supplement Report FDA Received Date: 12/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/02/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: NI
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE NARRATIVE IN H11.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 73 YR
• Patient Sex: Unknown