MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARCOS MODULAR REVISION HIP SYSTEM; PROSTHESIS, HIP

Catalog Number	11-302138
Medical Device Problem Codes	Migration (4003); Separation Problem (4043)
Health Effect - Clinical Codes	Pain (1994); Insufficient Information (4580)
Date of Event	09/05/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent a hip revision due to the trochanteric bolt backing out of the screw hole that is used to secure the trochanteric claw to the proximal body.It has not been confirmed which components were revised, but a screw was removed.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).D10: cat: 11-301816 lot: 128460 arcos 16x200mm intlkng dist.Cat: 166067 lot: 6130827 arcos distal screw ti 5x35mm.G2: foreign ¿ the netherlands.The customer has indicated that the product will not be returned to zimmer biomet for investigation, as its location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: b5; b7; d6; d9; g3; h2; h6 clinical.The following sections were corrected: d4 cat and lot; d4 expiry date and udi are unknown; h4 is unknown; h6 impact.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that approximately six years post-implantation, the patient underwent a left hip procedure due to the trochanteric bolt backing out of the screw hole that is used to secure the trochanteric claw to the proximal body and pain.The bolt and claw were removed and not replaced.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: d4; g3; h2; h3; h4; h6; h10.The following sections were corrected: b3; h6 component code.Visual examination of the returned product identified the bolt visually appears to be in good cosmetic condition, there are minor scratches around the mid shaft diameter.No other damage was noted during visual evaluation.The dimensions of the length of the bolt and tip length were measured and found to be within specification.This device has an approximate implantation age of 6 years.Only the bolt was returned.Review of the device history records identified no deviations or anomalies during manufacturing.Medical records/radiographs were provided.Review identified the following: patient had an initial left tha with unknown products.Patient underwent a two stage revision due to infection.During the stage 2 procedure, a trochanteric minor and major were found fractured and new arcos implants were placed along with arcos claw, bolt and new cerclage wires.Operative notes indicate there is good stability and function.The patient had an additional procedure due to the trochanteric bolt backing out of the screw hole.The bolt and claw were removed.No operative records were provided for this procedure.An x-ray image was provided, however was not further reviewed as the image does not provide a clear view of the bolt.A definitive root cause cannot be determined.Complaint 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 information is available at the time of this report.

• 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 ; 5745260384
• MDR Report Key: 23004028
• Report Number: 0001825034-2025-02837
• Device Sequence Number: 9468714
• Product Code: KWA
• UDI-Device Identifier: 00880304474406
• UDI-Public: (01)00880304474406(17)290409(10)420950
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K090757
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2025
• 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,Followup
• Report Date (Section B): 01/21/2026

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: 11-302138
• Device Lot Number: 420950
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 08/27/2025
• Supplement Date Received by Manufacturer: 10/02/2025; 01/15/2026
• Initial Report FDA Received Date: 09/09/2025
• Supplement Report FDA Received Date: 10/28/2025; 01/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/09/2019
• 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: Required Intervention; Hospitalization
• Patient Sex: Unknown