MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARCOS 18X200MM INTLKNG DIST; PROSTHESIS, HIP

Catalog Number	11-301818
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	04/03/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent a revision procedure two months post implantation due to a fracture around the stem in which the stem and liner were exchanged.There is no further information available at the time of this report.
Additional Manufacturer Narrative
(b)(4).D10: 11-301333 item name arcos con sz c hi 70mm lot # 65763339.11-301817 item name arcos 17x200mm intlkng dist lot # 65688545.010000984 item name g7 freedom const e1 lnr 36mm f lot # 7722339.G2: foreign: australia h6: stem the device will not be returned for analysis as it¿s location is not known; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch will be submitted.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.H6: component code: mechanical (g04) - stem.No product was returned or pictures of the devices provided; visual and dimensional evaluations could not be performed.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.The reported products were reviewed for compatibility with no issues noted.A radiograph was provided and showed multiple femoral fractures.A definitive root cause cannot be determined.The complaint was confirmed based on x-ray review of bone fractures.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 event information is available at the time of this report.

• Brand Name: ARCOS 18X200MM INTLKNG DIST
• 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: 21920704
• Report Number: 0001825034-2025-01225
• Device Sequence Number: 9022094
• Product Code: LZO
• UDI-Device Identifier: 00880304475168
• UDI-Public: (01)00880304475168(17)340325(10)66349599
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K100469
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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
• Report Date (Section B): 07/22/2025

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?: No
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 11-301818
• Device Lot Number: 66349599
• 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: 04/03/2025
• Supplement Date Received by Manufacturer: 07/16/2025
• Initial Report FDA Received Date: 04/28/2025
• Supplement Report FDA Received Date: 07/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/25/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: PLEASE SEE H11.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown