MAUDE Adverse Event Report: ZIMMER BIOMET, INC. AVENIR CMPL HA VAR COL SIZE 3; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER

Catalog Number	574203030
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	12/06/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D11: zimmer 12/14 32mm +0mm cocr head.Item number: 802203202.Lot number: 3213426.G2: foreign - event occurred in australia.H6: proposed component code: mechanical (g04) - stem.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Event or Problem Description
It was reported that following a primary total hip replacement, the patient required stem revision approximately 4 days post-implantation due to a lesser trochanter fracture identified after onset of pain upon standing.Approximately 1 day post-implantation, the patient stood and experienced pain; imaging demonstrated a lesser trochanter fracture, with no fall reported.Subsequently, the stem was revised to a revision total hip replacement.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: d4; g1; g3; h1; h2; h3; h4; h6 no product was returned or pictures provided; visual and dimensional evaluations could not be performed.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: ap view of the pelvis shows an acute periprosthetic peritrochanteric fracture.There is a displaced lesser trochanter fracture fragment and subsidence of the femoral stem.The device history record was reviewed and no discrepancies relevant to the reported event were found.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.A definitive root cause cannot be determined.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: AVENIR CMPL HA VAR COL SIZE 3
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER
• 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: 23942792
• Report Number: 0001822565-2026-00003
• Device Sequence Number: 18104162
• Product Code: LZO
• UDI-Device Identifier: 00889024509283
• UDI-Public: (01)00889024509283(17)290926(10)3212203
• 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): 03/10/2026

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?: No
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 574203030
• Device Lot Number: 3212203
• 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: 12/06/2025
• Supplement Date Received by Manufacturer: 03/10/2026
• Initial Report FDA Received Date: 01/02/2026
• Supplement Report FDA Received Date: 03/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/26/2024
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 83 YR
• Patient Sex: Unknown
• Patient Weight: 65 KG