MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARCOS MODULAR REVISION SYSTEM; PROSTHESIS, HIP, SEMI-CONSTRAINED (METAL UNCEMENTED ACETABULAR COMPONENT)

Catalog Number	11-301310
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/30/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a hip procedure, the screwdriver tip broke off in the proximal body while torquing the body to the distal stem.The broken piece was unable to be removed.The proximal body was also unable to be removed from the distal stem so the implants remained in place and the broken piece was retained in the patient.There was approximately a ten-minute delay in attempting to remove the broken screwdriver tip and the implants.There has been no known impact due to the retained screwdriver tip.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4)/ g2: foreign - event occurred in united kingdom.H6: proposed component code: mechanical (g04) ¿ stem 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.

• Brand Name: ARCOS MODULAR REVISION SYSTEM
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED (METAL UNCEMENTED ACETABULAR COMPONENT)
• 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: 25148170
• Report Number: 0001825034-2026-01260
• Device Sequence Number: 9397074
• Product Code: KWA
• UDI-Device Identifier: 00880304473799
• UDI-Public: (01)00880304473799(17)290907(10)603750
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/12/2026

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: Health Professional
• Device Catalogue Number: 11-301310
• Device Lot Number: 603750
• 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: 04/30/2026
• Initial Report FDA Received Date: 05/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/07/2019
• 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 Sex: Unknown