MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARCOS 15X150MM SPL TPR DIST; PROSTHESIS, HIP

Catalog Number	11-300815
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Pain (1994); Radiolucent Lines (4848)
Date of Event	04/30/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).H10: arcos con sz c std 60mm.Item: 11-301303, lot: 65710916.G7 osseoti multihole 58mm g.Item: 110010267, lot: 7196540.G7 hi-wall e1 liner 36mm g.Item: 010000937, lot: 7210981.G7 screw 6.5mm x 30mm.Item: 010000999, lot: 7389732.Delta ceramic fem hd 36/-3mm.Item: 650-0660, lot: 3095592.G2: foreign ¿ australia.H6: suggested component code: mechanical (g04) - stem.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 three years post-implantation due to pain and radiolucency of component.It was confirmed that no further information could be provided.

• Brand Name: ARCOS 15X150MM SPL TPR 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: 25230117
• Report Number: 0001825034-2026-01351
• Device Sequence Number: 10237921
• Product Code: KWA
• UDI-Device Identifier: 00880304474178
• UDI-Public: (01)00880304474178(17)330121(10)65750703
• 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 Implanted Year: 2023
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/20/2026

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: 11-300815
• Device Lot Number: 65750703
• 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: 04/30/2026
• Initial Report FDA Received Date: 05/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/21/2023
• 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: Hospitalization; Required Intervention
• Patient Sex: Unknown