MAUDE Adverse Event Report: ZIMMER GMBH AVENIR® MüLLER, STEM, LATERAL, UNCEMENTED, HA, 5, TAPER 12/14; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER

Catalog Number	0106010105
Medical Device Problem Codes	Difficult to Insert (1316); Peeled/Delaminated (1454)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	03/17/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).G2: foreign - event occurred in germany.The customer has indicated that the product is in process of being 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 primary total hip arthroplasty.During the procedure, the surgery attempted to further advance the femoral stem to correct excessive leg lengthening which resulted in a fissure of the femoral shaft.The stem was removed, and cerclage cables were placed around the shaft.Upon inspection of the explanted stem, the surgeon noted damage to the stem coating; therefore, a new stem of the same size was used.The procedure was completed without further complications.Diligence is completed and no further information on the reported event has been provided.

• Brand Name: AVENIR® MüLLER, STEM, LATERAL, UNCEMENTED, HA, 5, TAPER 12/14
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur
• Manufacturer (Section G): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 25021654
• Report Number: 0009613350-2026-00226
• Device Sequence Number: 10450808
• Product Code: LZO
• UDI-Device Identifier: 00889024591004
• UDI-Public: (01)00889024591004(17)300910(10)3247712
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• 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): 05/22/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 0106010105
• Device Lot Number: 3247712
• 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: 04/07/2026
• Supplement Date Received by Manufacturer: 05/21/2026
• Initial Report FDA Received Date: 04/28/2026
• Supplement Report FDA Received Date: 05/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/10/2025
• 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
• Patient Sex: Unknown