MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARCOS 15X200MM INTLKNG DIST; PROSTHESIS, HIP

Catalog Number	11-301815
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/10/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a patient underwent a hip revision approximately three months¿ post implantation due to a fractured stem.It was reported that no further information is available.
Additional Manufacturer Narrative
(b)(4).Report source: australia.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 will be submitted.
Event or Problem Description
No additional information.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.H6: proposed component code: mechanical (g04) - stem.The reported event was able to be confirmed by review of provided images and x-rays.Visual examination of the provided photos identified that the femoral stem had fractured at the distal end.Additionally, radiographs were provided and reviewed by a healthcare professional, which identified a left hip arthroplasty with a fractured femoral component at the level of the distal stem.Possible bony fracture along the medial cortex proximal femoral diaphysis.Review of the device history records identified no deviations or anomalies during manufacturing.A definitive root cause could not be determined.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.

• Brand Name: ARCOS 15X200MM 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: 16654653
• Report Number: 0001825034-2023-00681
• Device Sequence Number: 6500978
• Product Code: KWA
• UDI-Device Identifier: 00880304475144
• UDI-Public: (01)00880304475144(17)310521(10)228380
• 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: 2022
• Device Explanted Year: 2023
• 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): 07/03/2023

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: 11-301815
• Device Lot Number: 228380
• 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: 03/08/2023
• Supplement Date Received by Manufacturer: 06/27/2023
• Initial Report FDA Received Date: 03/31/2023
• Supplement Report FDA Received Date: 07/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/21/2021
• 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 Age: 46 YR
• Patient Sex: Female
• Patient Weight: 80 KG