BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MLRY-HD 3HOLE RLC SHL 54MM/L24

    MDR report key: 8606952 · Received May 14, 2019

    Report

    Report Number
    3002806535-2019-00451
    Event Type
    Injury
    Date Received
    May 14, 2019
    Date of Event
    April 1, 2019
    Report Date
    August 15, 2019
    Manufacturer
    BIOMET UK LTD.
    Product Code
    LPH
    PMA / PMN Number
    K030055
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL 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 INITIAL RIGHT HIP ARTHROPLASTY AND SUBSEQUENTLY WAS REVISED APPROXIMATELY TWO AND HALF YEARS LATER FOR CUP LOOSENING.

    Additional Manufacturer Narrative · 1

    (B)(4). FOREIGN SOURCE: (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A SUPPLEMENTAL MDR WILL BE SUBMITTED. CONCOMITANT MEDICAL PRODUCTS: MEDICAL PRODUCT: RINGLOC-X E1 H/W 54/36MM 24 CATALOG #: EP-053654, LOT #: 3650032, MEDICAL PRODUCT: DELTA CER FM HD 036/+4MM 12/14 , CATALOG #:650-0838, LOT #: 2016060741, MEDICAL PRODUCT: TI LOW PROFILE SCREW 6.5X20MM, CATALOG #:103531, LOT #: 2016030066, MEDICAL PRODUCT: TI LOW PROFILE SCREW 6.5X15MM, CATALOG #:103530, LOT #: 2328015. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2019-02093 AND 0001825034-2019-02094. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT INITIAL RIGHT HIP ARTHROPLASTY AND SUBSEQUENTLY WAS REVISED APPROXIMATELY TWO AND HALF YEARS LATER FOR CUP LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401803 MLRY-HD 3HOLE RLC SHL 54MM/L24 HIP PROSTHESIS LPH BIOMET UK LTD. N/A 3774190

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| R