BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DELTA CERAMIC FEM HD 36/-3MM

    MDR report key: 8415644 · Received March 13, 2019

    Report

    Report Number
    3002806535-2019-00267
    Event Type
    Injury
    Date Received
    March 13, 2019
    Date of Event
    November 11, 2015
    Report Date
    March 13, 2019
    Manufacturer
    BIOMET UK LTD.
    Product Code
    LZO
    PMA / PMN Number
    K042091
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: MEDICAL PRODUCT: EXCEED ABT E1 N/FLNG CUP 36X54, CATALOG #: EP-113654, LOT #: NOT REPORTED. REPORT SOURCE, FOREIGN - EVENT OCCURRED IN (B)(6). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 3002806535-2019-00268. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DHR REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. ROOT CAUSE WAS UNABLE TO BE DETERMINED. 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. PRODUCT NOT RETURNED.

    Description of Event or Problem · 1

    THE NATIONAL JOINT REGISTRY REPORTED THAT A PATIENT UNDERWENT AN INITIAL RIGHT HIP ARTHROPLASTY. SUBSEQUENTLY, A REVISION PROCEDURE WAS PERFORMED DUE TO UNKNOWN REASON. CUP AND HEAD WERE REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    209637 DELTA CERAMIC FEM HD 36/-3MM HIP PROSTHESIS LZO BIOMET UK LTD. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| R