BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SROM NRH DIST AUG XS/S/MD 10MM

    MDR report key: 7780925 · Received August 14, 2018

    Report

    Report Number
    1818910-2018-66562
    Event Type
    Injury
    Date Received
    August 14, 2018
    Date of Event
    August 26, 2011
    Report Date
    July 19, 2018
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. 1818910
    Product Code
    JWH
    UDI-DI
    10603295179559
    PMA / PMN Number
    K924940
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL NARRATIVE: IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. CONCOMITANT MED PRODUCTS: MBT REVISION CEM TIB TRAY SZ 2; SROM NRH FEM W/PIN XSMRT 66X58; LPS UNIV TIB HIN INS XSM 12MM; UNKNOWN KNEE PATELLA COMPONENT; DEPUY CMW 2 20G; UNIVERSAL FEM SLV FUL POR 31MM; UNIVERSAL STEM 75X14MM FLUTED; SROM NRH DIST AUG XS/S/MD 5MM; SROM NRH DIST AUG XS/S/MD 10MM; UNIVERSAL STEM 75X10MM FLUTED; MBT TRAY SLEEVE POR M/L 29MM.

    Additional Manufacturer Narrative · 1

    (B)(4). NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. A WORLDWIDE COMPLAINT DATABASE SEARCH FOUND NO OTHER RELATED REPORTED INCIDENT(S) AGAINST THE PROVIDED PRODUCT/LOT COMBINATION(S) SINCE RELEASE FOR DISTRIBUTION. THE INFORMATION RECEIVED WILL BE RETAINED FOR POTENTIAL SERIES INVESTIGATIONS IF TRIGGERED BY TREND ANALYSIS, POST MARKET SURVEILLANCE, OR OTHER EVENTS WITHIN THE QUALITY SYSTEM. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR ABOVE THE KNEE AMPUTATION RELATED TO WOUND DEHISCENCE. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS POSSIBLY RELATED TO DEVICE AND DEFINITELY RELATED TO PROCEDURE. DOE: (B)(6) 2011. DOI: (B)(6) 2011. DATE OF AMPUTATION: (B)(6) 2011 . (RIGHT, KNEE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    621145 SROM NRH DIST AUG XS/S/MD 10MM LPS AND S-ROM : KNEE FEMORAL ACCESSORY JWH DEPUY ORTHOPAEDICS, INC. 1818910 FL1V44 10603295179559

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention