BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVENIR CMPL HA VAR COL SIZE 3

    MDR report key: 23942792 · Received January 2, 2026

    Report

    Report Number
    0001822565-2026-00003
    Event Type
    Injury
    Date Received
    January 2, 2026
    Date of Event
    December 6, 2025
    Report Date
    March 10, 2026
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LZO
    UDI-DI
    00889024509283
    PMA / PMN Number
    K182048
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (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.

    Additional Manufacturer Narrative · 0

    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.

    Description of Event or Problem · 0

    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.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2987 AVENIR CMPL HA VAR COL SIZE 3 PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER LZO ZIMMER BIOMET, INC. 3212203 00889024509283

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Unknown Required Intervention| H SEE H11