BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CER BIOLOXD OPTION HD 28MM

    MDR report key: 17457387 · Received August 4, 2023

    Report

    Report Number
    3002806535-2023-00266
    Event Type
    Injury
    Date Received
    August 4, 2023
    Date of Event
    June 29, 2023
    Report Date
    August 3, 2023
    Manufacturer
    BIOMET UK LTD.
    Product Code
    LZO
    UDI-DI
    00887868271373
    PMA / PMN Number
    K082996
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10 - CER OPTION TYPE 1 TPR SLEVE -3 ITEM#650-1065, LOT#3050891. ACT ARTIC E1 HIP BRG 28X44MM ITEM#EP-200150, LOT#022880. G7 DUAL MOBILITY LINER 44MM F ITEM#110024464, LOT#639140. G2 ¿ FOREIGN ¿ JAPAN. 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. DEVICES ARE USED FOR TREATMENT. MEDICAL RECORDS WERE NOT PROVIDED. WITH THE AVAILABLE INFORMATION, 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 REVISION SURGERY DUE TO DUAL MOBILITY IMPLANT DISASSOCIATION WHEN THE BEARING DISASSOCIATED FROM THE HEAD, APPROXIMATELY TWO (2) YEARS, THREE (3) MONTHS FROM INITIAL SURGERY. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1810661 CER BIOLOXD OPTION HD 28MM PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS LZO BIOMET UK LTD. N/A 3050659 00887868271373

    Patients

    Seq Age Sex Outcome Treatment
    1 Prefer Not To Disclose Required Intervention| H SEE H10 NARRATIVE