MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARCOS 16X150MM SPL TPR DIST; PROSTHESIS, HIP

Catalog Number	11-300816
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Periprosthetic fracture (4902)
Date of Event	04/20/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during implantation of the new prosthesis, a distal femoral fracture occurred, and the canal was stabilized before proceeding.The patient sustained an intra-operative distal femoral fracture that was treated with cable fixation.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).Proposed component code: mechanical (g04) - stem.This is an initial/final report.G2: foreign - event occurred in china.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history records identified no deviations or anomalies during manufacturing.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: a patient with intertrochanteric fractures of the hip exhibited loosening of the fracture fixation hardware (antegrade nail and screws).During revision to total hip arthroplasty, a fracture of the femoral shaft is observed at and near the distal femoral stem.The post-op x-ray shows the presence of an arcos modular femoral revision system with a single cable encircling the femoral shaft at the level of the mid-distal femoral stem.An identified risk factor for implant loosening and periprosthetic fracture is generalized reduced bone mineral density.A definitive root cause cannot be determined.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.

• Brand Name: ARCOS 16X150MM SPL TPR DIST
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 25484651
• Report Number: 0001825034-2026-01731
• Device Sequence Number: 10513310
• Product Code: KWA
• UDI-Device Identifier: 00880304474239
• UDI-Public: (01)00880304474239(17)340210(10)66535846
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K090757
• 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,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/28/2026

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: 11-300816
• Device Lot Number: 66535846
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/10/2026
• Initial Report FDA Received Date: 06/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/10/2024
• 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: Hospitalization; Required Intervention
• Patient Sex: Unknown