BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DLT TS CER HD 12/14 40MM +5.0

    MDR report key: 6731193 · Received July 21, 2017

    Report

    Report Number
    1818910-2017-21434
    Event Type
    Injury
    Date Received
    July 21, 2017
    Date of Event
    June 21, 2017
    Report Date
    June 21, 2017
    Manufacturer
    DEPUY IRELAND 9616671
    Product Code
    LZO
    UDI-DI
    10603295033707
    PMA / PMN Number
    K071830
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    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.

    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.

    Description of Event or Problem · 1

    THE PATIENT WAS REVISED TO ADDRESS HIP DISLOCATION. IT WAS STATED THAT HIS HIP BROKE WHICH IMPLANTED THE SAME SURGEON ON THE SAME HOSPITAL. THE PATIENT'S INITIAL PINNACLE 62MM OD X 40MM ID +4 10 DEGREE CONSTRAINED LINER WAS REPLACED WITH A PINNACLE 62MM OD X 40MM ID +4 NEUTRAL CONSTRAINED LINER. THE INITIAL 40MM +5 BIOLOX DELTA TS FEMORAL HEAD WAS ALSO REPLACED WITH A MATCHING 40MM +5 BIOLOX DELTA TS FEMORAL HEAD. UPDATE (B)(6) 2017: ADDITIONAL INFORMATION. THAT THE PATIENT HAD A FRACTURED CONSTRAINED LINER. THIS COMPLAINT WAS UPDATED ON JUL 19, 2017.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    511235 DLT TS CER HD 12/14 40MM +5.0 HIP FEMORAL HEAD LZO DEPUY IRELAND 9616671 UNKNOWN 10603295033707

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| R