BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOLOX DELTA OPTION HEAD, 28MM

    MDR report key: 14998424 · Received July 13, 2022

    Report

    Report Number
    3002806535-2022-00302
    Event Type
    Injury
    Date Received
    July 13, 2022
    Date of Event
    March 19, 2021
    Report Date
    August 18, 2022
    Manufacturer
    BIOMET UK LTD.
    Product Code
    LZO
    UDI-DI
    00887868271373
    PMA / PMN Number
    K192683
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: 110024461, 186690, G7 DUAL MOBILITY LINER 38MM C; 110010242, 6882934, G7 OSSEOTI 3 HOLE SHELL 48MM C; 650-1066, 3050922, CER OPT TYPE 1 TPR SLEVE 0MM; 51101080, 6341287, FEMORAL 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: B4, B5, G3, G6, H1, H2, H6, H10. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. REVIEW OF THE DEVICE HISTORY RECORD IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. DEVICE IS USED FOR TREATMENT. RELEVANT MEDICAL RECORDS WERE NOT PROVIDED, X-RAYS PROVIDED WERE POST DISLOCATION THEREFORE OF NO USE TO THE INVESTIGATION. 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 PATIENT UNDERWENT INITIAL LEFT HIP ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT UNDERWENT A CLOSED REDUCTION UNDER ANESTHESIA APPROXIMATELY 2 DAYS POST IMPLANTATION DUE TO A LEFT HIP DISLOCATION AFTER SUFFERING FROM A FALL. THE FALL OCCURRED WHILE WALKING TO THE BATHROOM IN A PRIVATE RESIDENCE. ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    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
    1715685 BIOLOX DELTA OPTION HEAD, 28MM PROSTHESIS, HIP LZO BIOMET UK LTD. N/A 3035116 00887868271373

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Unknown Required Intervention| H