MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARCOS CON SZ C HI 70MM; PROSTHESIS, HIP

Catalog Number	11-301333
Medical Device Problem Code	Implant subsidence (4078)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	11/20/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D6a implanted date: unknown date in (b)(6) 2024.D10: arcos 19x190mm spl tpr dist.Item: 11-300919.Lot: 65688222.G7 dual mobility liner 46mm g.Item: 110024465.Lot: 66036115.Act artic e1 hip brg 28x46mm.Item: ep-200152.Lot: 65920930.G2: foreign ¿ australia.The product was requested but was not returned by the hospital and will therefore not be sent to zimmer biomet for investigation.Once the investigation has been completed, a supplemental mdr will be submitted.
Event or Problem Description
It was reported that the patient underwent a hip revision approximately 1-year post implantation due to joint dislocation and gross subsidence of the femoral implant.It was confirmed that no further information could be provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: d4; g3; h2; h3; h4; h6; h10.Visual examination of the provided pictures identified the explanted products, bio-debris present.These cannot be used to confirm the reported event.Devices not returned, further analysis cannot be made.Review of the device history records identified no deviations or anomalies during manufacturing.Radiographs were provided and reviewed by a third-party health care professional.Review of the available records identified the following: long-stem hip prosthesis noted with dislocation of the femoral head prosthesis from the acetabular cup.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 additional information available for the reported event.

• Brand Name: ARCOS CON SZ C 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: 23831544
• Report Number: 0001825034-2025-04041
• Device Sequence Number: 20100598
• Product Code: KWA
• UDI-Device Identifier: 00880304474260
• UDI-Public: (01)00880304474260(17)331106(10)66157926
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K090757
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 01/15/2026

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?: Yes
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 11-301333
• Device Lot Number: 66157926
• 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: 11/20/2025
• Supplement Date Received by Manufacturer: 01/15/2026
• Initial Report FDA Received Date: 12/17/2025
• Supplement Report FDA Received Date: 01/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/06/2023
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown