MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 1.3MM CABLE W/NEEDLE CRIMPS TI; CERCLAGE, FIXATION

Catalog Number	00223202113
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Loss of Range of Motion (2032); Malunion of Bone (4529)
Date of Event	12/24/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This event is recorded by zimmer biomet under (b)(4).G2, country event occurred in: china.The product is in the process of being evaluated by zimmer biomet.Once the product investigation has been completed, a follow up/final report will be submitted.
Event or Problem Description
It was reported that the patient underwent knee surgery to stabilize a fractured patella.Subsequently, the cable implant fractured.However, the patient will not be undergoing any revision surgery because the surgeon recommended conservative treatment at this time.The patient did not suffer any trauma that could have contributed to the event, but it is noted that the patient's fracture was not healing.The patient is experiencing knee joint stiffness and limited flexion.Due diligence is complete.No additional information is available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were corrected: h4 the following sections were updated: b4, b5, g3, g6, h2, h3, h6, h11 no product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record(s) identified no deviations or anomalies during manufacturing.Medical records/radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: pin and screw fixation of a markedly comminuted patellar fracture with a wide central articular surface gap and a fractured wire cable superiorly.A definitive root cause cannot be determined.The reported event is confirmed by mmi review if any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
No further event information is available at the time of this report.

• Brand Name: 1.3MM CABLE W/NEEDLE CRIMPS TI
• Common Device Name: CERCLAGE, FIXATION
• 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: 21676868
• Report Number: 0001822565-2025-00704
• Device Sequence Number: 20885478
• Product Code: JDQ
• UDI-Device Identifier: 00889024039612
• UDI-Public: (01)00889024039612(17)320529(10)65321904
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K151848
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 04/16/2025

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: Health Professional
• Device Catalogue Number: 00223202113
• Device Lot Number: 65321904
• 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: 02/26/2025
• Supplement Date Received by Manufacturer: 04/11/2025
• Initial Report FDA Received Date: 03/24/2025
• Supplement Report FDA Received Date: 04/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/06/2022
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 58 YR
• Patient Sex: Male