MAUDE Adverse Event Report: ZIMMER BIOMET, INC. AVENIR COMPLETE; PROSTHESIS, HIP

Catalog Number	574202050
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Implant subsidence (4078)
Health Effect - Clinical Code	Periprosthetic fracture (4902)
Date of Event	07/01/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: unk head; cat: 110031012, lot: 66806486 bearing.G2: foreign, australia.H6: proposed component code: mechanical (g04), stem.The customer has indicated that the product will not be returned to zimmer biomet for investigation, as it was not returned by the hospital.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that approximately two months post-implantation, the patient underwent a hip revision due to stem subsidence that progressed to a fracture around the prosthesis.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: g3; h2; h3; h6.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.Review of the available records identified the following: cementless left total hip arthroplasty is thought to exhibit femoral stem subsidence, and is associated with a periprosthetic fracture of the proximal femoral shaft.Under sizing of the femoral stem component and excessive reaming of the proximal femur with respect to the size of the femoral component implanted may be contributing factors to subsidence.A definitive root cause cannot be determined.This complaint is confirmed.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
No further information is available at the time of this report.

• Brand Name: AVENIR COMPLETE
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 22575570
• Report Number: 0001822565-2025-02614
• Device Sequence Number: 15817003
• Product Code: LZO
• UDI-Device Identifier: 00889024509177
• UDI-Public: (01)00889024509177(17)300226(10)3224733
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K182048
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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): 10/21/2025

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: 574202050
• Device Lot Number: 3224733
• 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: 07/01/2025
• Supplement Date Received by Manufacturer: 10/21/2025
• Initial Report FDA Received Date: 07/23/2025
• Supplement Report FDA Received Date: 11/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/26/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Male