BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASPHERE M SPEC 12/14 40 +8.5

    MDR report key: 7545447 · Received May 25, 2018

    Report

    Report Number
    1818910-2018-60617
    Event Type
    Injury
    Date Received
    May 25, 2018
    Date of Event
    July 11, 2010
    Report Date
    April 26, 2018
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. 1818910 
    Product Code
    KWA
    UDI-DI
    10603295033011
    PMA / PMN Number
    K073504
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. 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. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY. 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

    PINNACLE PFF RECORD RECEIVED. PFF ALLEGES ABDUCTOR MUSCLE REPAIR AND INFECTION REQUIRING IV ANTIBIOTICS. DOI: (B)(6) 2010; DOR: (B)(6) 2010; RIGHT HIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    386172 ASPHERE M SPEC 12/14 40 +8.5 ARTICULEZE HEAD (12/14 TAPER) : HIP METAL FEMORAL HEADS KWA DEPUY ORTHOPAEDICS, INC. 1818910  3104620 10603295033011

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention