MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARCOS CON SZ A HI 80MM; PROSTHESIS, HIP

Catalog Number	11-301351
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)
Health Effect - Clinical Codes	Failure of Implant (1924); Insufficient Information (4580)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that a patient underwent a left knee arthroplasty on an unknown date.Subsequently, the patient plans to be revised due to an unknown reason.A new arcos extension has been requested.The patient currently has a 80mm cone body in place.Attempts have been made and all available information has been provided.
Event or Problem Description
It was reported that the patient will need to undergo a hip revision in the future due to subsidence of the femoral component.The patient has poor bone quality which may have contributed to it.There is no additional information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: b1, b4, b7, d1, d4, d10: 11-300920 item name arcos 20x190mm spl tpr dist lot # 064880, g3, g6, h2, h11.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: b4 g3 g6 h2 h6: suggested component code: mechanical (g04) - stem h11.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history records identified no deviations or anomalies during manufacturing.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: subsidence of the femoral component.Possible fracture along the greater trochanter.A definitive root cause cannot be determined.The complaint is confirmed based on the x-ray findings.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
There is no update to the prior event description provided.

• Brand Name: ARCOS CON SZ A HI 80MM
• 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: 21218695
• Report Number: 0001825034-2025-00193
• Device Sequence Number: 11623499
• Product Code: KWA
• UDI-Device Identifier: 00880304473911
• UDI-Public: (01)00880304473911(17)330308(10)65688442
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K090757
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/30/2025

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: 11-301351
• Device Lot Number: 65688442
• 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: 01/10/2025
• Supplement Date Received by Manufacturer: 01/23/2025; 05/14/2025
• Initial Report FDA Received Date: 01/23/2025
• Supplement Report FDA Received Date: 02/12/2025; 05/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/08/2023
• 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: Other
• Patient Sex: Male
• Patient Weight: 77 KG