BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVANTAGE CMNTD SHELL SS 46MM

    MDR report key: 23775883 · Received December 11, 2025

    Report

    Report Number
    3002806535-2025-00596
    Event Type
    Injury
    Date Received
    December 11, 2025
    Date of Event
    November 19, 2025
    Report Date
    March 20, 2026
    Manufacturer
    BIOMET UK LTD.
    Product Code
    LZO
    UDI-DI
    03599870013076
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D-4: THIS DEVICE IS SOLD OUTSIDE THE US AND THEREFORE NO GUDID INFORMATION EXISTS. THIS DEVICE IS CONSIDERED SIMILAR TO 00880304524309. D:10 110031010, VIVACIT-E DM BEARING 28X40MM, LOT 66854519. G2: FOREIGN - EVENT OCCURRED IN AUSTRALIA. G-4: THE REPORTED PRODUCT IS NOT SOLD IN THE US, THE PRE-MARKET SUBMISSION NUMBER FOR THE SIMILAR PRODUCT SOLD IN THE US IS K121874. 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: B4, B5, G3, G6, H2, H3, H6, H11. THE FOLLOWING SECTIONS WERE CORRECTED: E2, E3. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. A REVIEW OF THE DEVICE MANUFACTURING RECORDS CONFIRMED NO ABNORMALITIES OR DEVIATIONS. REVIEW OF THE COMPLAINT HISTORY FOUND NO ADDITIONAL RELATED COMPLAINTS FOR THIS/THESE ITEM AND THE REPORTED PART AND LOT COMBINATION. MEDICAL RECORDS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. THE REPORTED EVENT WAS CONFIRMED BY REVIEW OF X-RAYS. TIMELINE UNCERTAIN, BUT ONE OF THE IMAGES SHOWS ANTERIOR SUPERIOR HIP DISLOCATION. ANOTHER IMAGE SHOWS MEDIAL ACETABULAR WALL FRACTURE WITH MEDIAL DISPLACEMENT OF THE QUADRILATERAL PLATE FRAGMENT AND MILD PROTRUSION AND SUPERIOR DISPLACEMENT OF THE ACETABULAR CUP. A THIRD IMAGE SHOWS IMPROVED ACETABULAR CUP POSITION WITH NORMAL CUP INCLINATION. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION OF THE ACETABULAR COMPONENT MORE THAN TEN YEARS POST-IMPLANTATION DUE TO RECURRENT HIP DISLOCATIONS. SUBSEQUENTLY, THE PREVIOUSLY IMPLANTED SHELL WAS REMOVED, AND A CEMENTED CUP AND BEARING WERE IMPLANTED WITH A TAPER ADAPTER AND HEAD. THEREAFTER, THE PATIENT PRESENTED WITH AN ACETABULAR FRACTURE WITH THE CUP DISPLACED INTRAPELVICALLY AND UNDERWENT RE-REVISION IN WHICH THE CEMENTED CUP WAS REMOVED, A REVISION SHELL WAS IMPLANTED WITH A CEMENTED CUP, AND A NEW BEARING, TAPER ADAPTER, AND HEAD WERE IMPLANTED. 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
    2722210 AVANTAGE CMNTD SHELL SS 46MM HIP PROTHESIS LZO BIOMET UK LTD. 0001918615 03599870013076

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Hospitalization| R