BEUDAMED
    FDA Adverse Event Injury Summary report: N

    S-ROM*SLEEVE PRX ZTT, 22B-LRG

    MDR report key: 7698176 · Received July 18, 2018

    Report

    Report Number
    1818910-2018-64678
    Event Type
    Injury
    Date Received
    July 18, 2018
    Date of Event
    December 5, 2006
    Report Date
    June 21, 2018
    Manufacturer
    DEPUY ORTHOPAEDIC INC, 1818910
    Product Code
    LPH
    UDI-DI
    10603295170600
    PMA / PMN Number
    K934412
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER CAREGIVERS

    Narratives

    Additional Manufacturer Narrative · 1

    PC-(B)(4).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

    PRODUCT COMPLAINT # (B)(4). 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

    COMPLAINT DESCRIPTION: LITIGATION ALLEGES THE PATIENT SUFFERS FROM PAIN, DISCOMFORT, IMMOBILITY, INFLAMMATION AND HIGH LEVELS OF CHROMIUM AND COBALT. UPDATE AD MAY 29, 2018: (B)(4) HAS BEEN RE-OPENED UNDER (B)(4) DUE TO THE RECEIPT OF PPF AND STICKER SHEETS RECORD. PPF ALLEGES INFECTION REQUIRING IV ANTIBIOTICS AND LOOSENING OF STEM. UPDATED PRODUCT AND LOT NUMBER OF INSERT (121887356/2136865), HEAD ( 136531000/2193018), STEM ( 523422/2160316), CUP (121722056/A5WFX1000).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    539366 S-ROM*SLEEVE PRX ZTT, 22B-LRG S-ROM HIP SYSTEM : HIP FEMORAL SLEEVE LPH DEPUY ORTHOPAEDIC INC, 1818910 1811741 10603295170600

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other