MAUDE Adverse Event Report: ZIMMER BIOMET, INC. CABLE CERCLAGE CABLE WITH CRIMP; ORTHOPAEDIC BONE WIRE

Catalog Number	00223200418
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	11/24/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: mod femoral prox locking screw, cat# 11-301000, lot#837900; 36mm cocr mod hd -6mm, cat# 11-363660, lot#743900; arcos con sz a hi 50mm, cat# 11-301310, lot#66160889; arcos 16x150mm spl tpr dist, cat# 11-300816, lot#661109549; g7 neutral e1 liner 28mm c, cat# 010000837, lot#unk.G2: 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.
Event or Problem Description
It was reported that a patient underwent a hip revision procedure approximately 4 months post implantation due to a proximal femur fracture.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.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: single ap view of the left hip demonstrates a left total hip arthroplasty with screw fixation of the acetabular cup.Asymmetric position of the femoral head within the acetabular cup suggests polyethylene wear.Cerclage wire along the proximal femoral component with an oblique periprosthetic fracture involving the proximal femoral diaphysis medial and lateral cortices.It was reported the cables were placed for prophylactic banding.As the cables performed their intended function, no device problem was identified regarding the cables.The reported event is not confirmed.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: CABLE CERCLAGE CABLE WITH CRIMP
• Common Device Name: ORTHOPAEDIC BONE WIRE
• 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: 20832265
• Report Number: 0001822565-2024-03788
• Device Sequence Number: 4069991
• Product Code: KTT
• UDI-Device Identifier: 00889024039513
• UDI-Public: (01)00889024039513(17)3400601(10)66700639
• 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: 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): 01/15/2025

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?: No
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 00223200418
• Device Lot Number: 66700639
• 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: 11/25/2024
• Supplement Date Received by Manufacturer: 01/13/2025
• Initial Report FDA Received Date: 12/03/2024
• Supplement Report FDA Received Date: 01/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2024
• 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: Required Intervention; Hospitalization
• Patient Sex: Male