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

Catalog Number	574777110
Medical Device Problem Codes	Device-Device Incompatibility (2919); Damaged Thread (4075)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/26/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).D10: cat # 574203030, lot# 3232453, avenir cmpl ha var col size 3 g2: foreign, event occurred in japan.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 during the hip procedure, the extractor adapter threads were damaged and it would not connect with the stem.There was a delay less than 30 minutes and the surgeon was able to remove the stem.There was no known impact or consequences to the patient.Attempts have been made and no further information has been provided.

• Brand Name: AVENIR COMPLETE
• Common Device Name: INSTRUMENT, 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: 24038339
• Report Number: 0001822565-2026-00136
• Device Sequence Number: 9260593
• Product Code: LZO
• UDI-Device Identifier: 00889024509825
• UDI-Public: (01)00889024509825(11)210308(10)65010044
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K182048
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 06/23/2026

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: 574777110
• Device Lot Number: 65010044
• 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: 01/07/2026
• Supplement Date Received by Manufacturer: 06/10/2026
• Initial Report FDA Received Date: 01/12/2026
• Supplement Report FDA Received Date: 06/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/08/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown