BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVANTAGE INSERT 44/22

    MDR report key: 6824755 · Received August 28, 2017

    Report

    Report Number
    3006946279-2017-00143
    Event Type
    Injury
    Date Received
    August 28, 2017
    Date of Event
    November 23, 2015
    Report Date
    August 28, 2017
    Manufacturer
    BIOMET FRANCE S.A.R.L.
    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). 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; HOWEVER, IT HAS BEEN DETERMINED THE EVENT IS UNRELATED TO THE DEVICE. THE SURGEON REPORTED THE EVENT IS RELATED TO THE INITIAL PROCEDURE. (B)(4). REPORT SOURCE, FOREIGN ¿ EVENT OCCURRED IN (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. THIS EVENT WAS PREVIOUSLY REPORTED UNDER 3002806535-2017-00465. 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 · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT IRRIGATION, DEBRIDEMENT AND ANTIBIOTIC TREATMENT ONE MONTH POST-IMPLANTATION DUE TO WOUND DEHISCENCE. 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
    603375 AVANTAGE INSERT 44/22 PROSTHESIS, HIP LPH BIOMET FRANCE S.A.R.L. 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