BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVANTAGE INSERT

    MDR report key: 6608459 · Received June 2, 2017

    Report

    Report Number
    3002806535-2017-00465
    Event Type
    Injury
    Date Received
    June 2, 2017
    Date of Event
    November 23, 2015
    Report Date
    July 24, 2017
    Manufacturer
    BIOMET UK LTD.
    Product Code
    LPH
    PMA / PMN Number
    PSEE H10
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6). THIS PRODUCT IS MANUFACTURED BY ZIMMER BIOMET (B)(4) AND IS NOT CLEARED OR DISTRIBUTED IN THE U.S. HOWEVER, THIS REPORT IS BEING SUBMITTED AS ZIMMER BIOMET (B)(4) MANUFACTURES A SIMILAR DEVICE THAT IS CLEARED OR DISTRIBUTED IN THE UNITED STATES UNDER 510(K) NUMBER K101336. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2017-03474, 0001825034-2017-03477, 0001825034-2017-03478, AND 0001825034-2017-03479.

    Additional Manufacturer Narrative · 1

    UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED AN MDR SHOULD NOT HAVE BEEN FILED UNDER THE CURRENT MFR NUMBER. THIS EVENT WILL BE REPORTED UNDER (B)(6) MFR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT IRRIGATION, DEBRIDEMENT AND ANTIBIOTIC TREATMENT ONE MONTH POST-IMPLANTATION DUE TO WOUND DEHISCENCE. NO PRODUCTS WERE REPORTED TO HAVE BEEN REVISED. THE WOUND DEHISCENCE WAS REPORTED TO BE UNRELATED TO THE IMPLANTED DEVICES; HOWEVER, RELATED TO THE INITIAL IMPLANT PROCEDURE. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    388563 AVANTAGE INSERT PROTHESIS, HIP LPH BIOMET UK LTD. N/A 0000900990

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention ARCOS DISTAL BODY PN22-300814 LN396080| ARCOS PROXIMAL BODY PN22-301301 LN725630| MODULAR HEAD PN164440 LN00J3315968| REGENEREX SHELL PNPT-124858 LN642120