MAUDE Adverse Event Report: Zimmer Biomet, Inc. Arcos Modular Revision Hip System; Prosthesis, hip

Catalog Number	11-300820
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Loss of Range of Motion (2032)
Date of Event	03/10/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that approximately two months post-implantation, the patient underwent a hip revision due to the patient being unable to internally rotate their foot.There was a suspected failure of the taper junction or proximal body locking screw.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).H6: proposed component code: mechanical (g04) ¿ stem.Complaint is not confirmed.Visual examination of the provided picture identified explanted stem and screw, bio-debris present, however it cannot be used to confirm the reported event.Devices not returned, further analysis cannot be made.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.Review of complaint history found no additional related issues for these items and the reported part and lot combinations.Medical records were not provided.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 Modular Revision Hip System
• 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 ; +1(574)526-0384
• MDR Report Key: 50193256
• Report Number: 0001825034-2026-02318
• Device Sequence Number: 20363958
• Product Code: KWA
• UDI-Device Identifier: 00880304474215
• UDI-Public: (01)00880304474215(17)340216(10)66456848
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/10/2026

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?: Yes
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 11-300820
• Device Lot Number: 66456848
• 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: 07/13/2026
• Initial Report FDA Received Date: 08/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/16/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male