MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARCOS MODULAR REVISION HIP SYSTEM CON SZ A HI 70MM; PROSTHESIS, HIP

Catalog Number	11-301331
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/11/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent an initial hip procedure.Subsequently, the patient was revised approximately 6 years later due to a fractured proximal body of the stem.Attempts have been made, and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).D10: cat# 650-1057 lot# 2948084 cer bioloxd option hd 36mm.Cat# 650-1067 lot# 2961010 cer option type 1 tpr sleeve +3.The customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were {update/corrected} updated: d5; d9; g3; h2; h3; h6 visual examination of the returned product identified the cone body is fractured around the proximal end of taper that mates with the stem, both pieces of the cone body were returned.Porous coating has some gouging, cone body neck has scuffs and scratches.Hex screw from stem is still present within the cone body.No other damage was noted.The stem was submitted for further analysis.Analysis determined that the cause of the failure to be bending fatigue.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: left femoral implant fracture and proximal implant loosening as noted.Questionable proximal femoral osseous fracture as noted a definitive root cause cannot be determined.This complaint was confirmed based on the returned, fractured device.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 at the time of this report.

• Brand Name: ARCOS MODULAR REVISION HIP SYSTEM CON SZ A HI 70MM
• 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: 21525304
• Report Number: 0001825034-2025-00548
• Device Sequence Number: 20917720
• Product Code: KWA
• UDI-Device Identifier: 00880304474628
• UDI-Public: (01)00880304474628(17)290405(10)714540
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• 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: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/03/2025

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: 11-301331
• Device Lot Number: 714540
• 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: 02/11/2025
• Supplement Date Received by Manufacturer: 07/02/2025
• Initial Report FDA Received Date: 03/05/2025
• Supplement Report FDA Received Date: 07/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/05/2019
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11 NARRATIVE.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male