MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARCOS MODULAR REVISION HIP SYSTEM; Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)

Catalog Number	11-300814
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Periprosthetic fracture (4902)
Date of Event	08/26/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).H6: proposed component code: mechanical (g04) - stem.The customer has indicated that the product will not be returned to zimmer biomet for investigation.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 during a hip procedure, a nondisplaced fracture occurred when implanting the final stem despite prophylactic cabling.Additional cables were used for stability.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: d4; h2; h3; h4; h6 complaint is confirmed.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record identified no deviations or anomalies during manufacturing.Review of complaint history identified additional similar complaints for the reported item and no additional complaints for the reported part and lot combination.Medical records were provided.Review identified the following: the patient had a stage 2 revision.Preoperative cultures were negative.There was significant scar tissue around the hip.Significant acetabular bone loss noted due to multiple surgeries.A reconstruction shell was inserted into the acetabulum to maximum bone coverage.There was a small amount of inherent stability.Multiple screws were placed into the acetabular cup to improve fixation of the implant.A cage was then contoured to fit and then placed over the acetabular component.The cage was fixed in place with multiple screws, a slot in the ischium and one screw through the cage.A cup was then cemented into the cage with proper abduction angle and anteversion.Cerclage wires were placed around the femur.Femur was reamed with 14mm tapered reamer for the implant.The 14mm tapered distal femoral implant was then impacted into place.A nondisplaced fracture was then noted and additional cerclage wires were added to prevent propagation of the fracture.Remaining components implanted without further complication, leg lengths equal, stable rom achieved.Intraop cultures are negative and postop x-rays are negative.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report 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, 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: 25151439
• Report Number: 0001825034-2026-01263
• Device Sequence Number: 16139829
• Product Code: KWA
• UDI-Device Identifier: 00880304474154
• UDI-Public: (01)00880304474154(17)340716(10)66733634
• 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: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/10/2026

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 11-300814
• Device Lot Number: 66733634
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/16/2026
• Supplement Date Received by Manufacturer: 09/09/2026
• Initial Report FDA Received Date: 05/12/2026
• Supplement Report FDA Received Date: 09/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/16/2024
• 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: Female
• Patient Weight: 127 LB