MAUDE Adverse Event Report: ZIMMER BIOMET, INC. CABLE-READY CABLE GRIP SYSTEM CERCLAGE CABLE WITH CRIMP; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION

Catalog Number	00223200418
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Heart Problem (4454)
Date of Event	10/25/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent a right hip revision approximately three (3) weeks post-implantation due to a peri-prosthetic fracture where the patient received a new bearing, head, and cemented stem were implanted and cabled.Subsequently one (1) day post-revision, the patient was transferred to a different facility for unknown cardiac issues.It is unknown what treatment was provided or why the patient needed to be transferred.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).D10: item# 00223200418; lot# 66323544.Item# 00223200418; lot# 66081021.Item# 00223200418; lot# 66722992.Item# 00223200418; lot# 66108551.Item# 00223200418; lot# 66053938.Item# 00223200301; lot# 65749856.Item# 00223200318; lot# 63406394.Item# 00223200318; lot# 65240136.Item# 00223200318; lot# 64438890.Item# 00223200318; lot# 65438577.Item# 00223200318; lot# 63979245.Item# 00223200318; lot# 64420727.Item# 5036964; lot# 63681130.Item# 5036966; lot# 69871419.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product remains implanted.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.
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; h4; h6; h10.Review of the reported event by a health care professional found: patients are assessed prior to surgery to detect any risks for cardiac complications; however, at times even with a complete work up, a patient may experience cardiac ischemia.The stress of surgery can lead to myocardial ischemia or infarction via multiple mechanisms including coronary artery plaque rupture and myocardial demand ischemia.This leads to cardiac dysfunction caused by insufficient blood flow to the coronary arteries.This at times may be masked due to anesthesia.This is a procedural related complication due to the stress of surgery and not related to a device.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.This is a limited investigation,; therefore, a review of the device history record will not be completed for limited investigation complaints as the product meets the applicable acceptance criteria.The root cause of the reported event was determined to be unrelated to the device.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 CERCLAGE CABLE WITH CRIMP
• 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: 23822066
• Report Number: 0001822565-2025-04551
• Device Sequence Number: 9299439
• Product Code: KTT
• UDI-Device Identifier: 00889024039513
• UDI-Public: (01)00889024039513(17)350527(10)67283878
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K151907
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/02/2026

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: 67283878
• 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: 11/18/2025
• Supplement Date Received by Manufacturer: 03/23/2026
• Initial Report FDA Received Date: 12/16/2025
• Supplement Report FDA Received Date: 04/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/29/2025
• 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: Other
• Patient Sex: Male