MAUDE Adverse Event Report: ZIMMER BIOMET, INC. AVENIR CMPL BROACH SIZE 4; Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented

Catalog Number	574999040
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/13/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).G2: foreign ¿ spain.H6: proposed component code: mechanical (g04)- rasp.Customer has indicated that the product is in process of being returned 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 pivot of the rasp of the avenir complete stem bork while properly striking the rasp handle to extract the rasp from the femoral canal, leaving the rasp inside the patient until it could be removed using appropriate instruments.It was noted that a delay occurred, and no foreign body was retained in the patient.The case was competed successfully with no other reported impact.Due diligence is in progress for this complaint; to date no additional information or product has been received.

• Brand Name: AVENIR CMPL BROACH SIZE 4
• Common Device Name: Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
• 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: 24952768
• Report Number: 0001822565-2026-01354
• Device Sequence Number: 12078536
• Product Code: LZO
• UDI-Device Identifier: 00889024510142
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K182048
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/22/2026

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: 574999040
• Device Lot Number: 65470258
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/04/2026
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/14/2026
• Supplement Date Received by Manufacturer: 09/22/2026
• Initial Report FDA Received Date: 04/22/2026
• Supplement Report FDA Received Date: 09/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/13/2022
• 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: Reuse
• 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
• Patient Sex: Unknown