BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVANTAGE INLAY S50 / 28

    MDR report key: 21408775 · Received February 19, 2025

    Report

    Report Number
    3002806535-2025-00076
    Event Type
    Injury
    Date Received
    February 19, 2025
    Date of Event
    October 18, 2024
    Report Date
    February 19, 2025
    Manufacturer
    BIOMET UK LTD.
    Product Code
    LZO
    UDI-DI
    03599870005309
    PMA / PMN Number
    K121874
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D6A: PATIENT UNDERWENT AN INITIAL HIP ARTHROPLASTY IN (B)(6) 2022. D10: ITEM # 0106010005, AVENIR® MüLLER, STEM, STANDARD, UNCEMENTED, HA, 5, TAPER 12/14, LOT # 3080673. ITEM # P0461070, AVAN ACET SHELL PEG, LOT # 0001551348. ITEM # P0461070, AVAN ACET SHELL PEG, LOT # 0001552947. ITEM # P0606038, AVAN TAP CORT SCR SS 4.5X38MM, LOT # 0001327704. ITEM # 802202803, FEMORAL HEAD 12/14 TAPER 28 MM DIAMETER +3.5 MM NECK LENGTH, LOT # 2998968. ITEM # P0461P50, AVANTAGE 3P CUP PLASMA HA S50, LOT # 0001524547. G2¿FOREIGN¿AUSTRALIA. NO PRODUCT WAS RETURNED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. PICTURES PROVIDED SHOWS THE HEAD, THE CUP AND THE INLAY REMOVED FROM THE PATIENT. THE INLAY IS FRACTURED. IT COULD NOT BE DETERMINED WHEN THE INLAY HAS BEEN FRACTURED. A REVIEW OF THE DEVICE MANUFACTURING RECORDS CONFIRMED NO ABNORMALITIES OR DEVIATIONS FOR BOTH PRODUCTS. REVIEW OF THE COMPLAINT HISTORY FOUND NO ADDITIONAL RELATED COMPLAINTS FOR THIS ITEM AND THE REPORTED PART AND LOT COMBINATION. RADIOGRAPHS WERE PROVIDED AND REVIEWED. THE REVIEW IDENTIFIED AP PELVIS AND SINGLE VIEW OF THE LEFT HIP DEMONSTRATES A LEFT TOTAL HIP ARTHROPLASTY IN PLACE WITH POSSIBLE ASYMMETRIC POSITION OF THE FEMORAL HEAD WITHIN THE ACETABULAR CUP WHICH COULD INDICATE UNDERLYING POLYETHYLENE WEAR. PLATE AND SCREW FIXATION DEVICE OF THE ACETABULUM ALSO PRESENT. NO RADIOLUCENCY. NO ACUTE FRACTURE. NO EVIDENCE FOR IMPINGEMENT. A DEFINITIVE ROOT CAUSE COULD NOT 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 HIP REVISION SURGERY APPROXIMATELY 2 YEARS POST IMPLANTATION DUE TO THE STEM IMPINGING ON THE CUP. THE STEM REMAINED IMPLANTED. THE HEAD, LINER AND SHELL WERE REPLACED. ATTEMPTS HAVE BEEN MADE AND ALL ADDITIONAL INFORMATION RECEIVED HAS BEEN INCLUDED IN THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2668932 AVANTAGE INLAY S50 / 28 HIP PROSTHESIS LZO BIOMET UK LTD. 0001538077 03599870005309

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Hospitalization| R SEE H11 NARRATIVE