BEUDAMED
    FDA Adverse Event Injury Summary report: N

    S-ROM HEAD FEMRL ZIRCONIA 28+0

    MDR report key: 1850849 · Received September 28, 2010

    Report

    Report Number
    1818910-2010-07066
    Event Type
    Injury
    Date Received
    September 28, 2010
    Date of Event
    September 17, 2010
    Report Date
    September 17, 2010
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    LZO
    PMA / PMN Number
    K921111
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. A COMPLAINT DATABASE SEARCH FINDS NO OTHER REPORTED INCIDENTS AGAINST THE PROVIDED PRODUCT AND LOT COMBINATION SINCE ITS RELEASE FOR DISTRIBUTION. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT. IT HAS BEEN REPORTED THAT THE DEPUY DEVICE WAS IMPLANTED WITH COMPETITOR MANUFACTURED PRODUCTS. THIS USE OF THE DEPUY DEVICE IS NOT RECOMMENDED. BASED ON THE INABILITY TO DETERMINE A ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADDITIONAL INFO BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Description of Event or Problem · 1

    PT REVISED FOR PAIN AND OSTEOLYSIS. CUP AND LINER MFG BY OTHERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 S-ROM HEAD FEMRL ZIRCONIA 28+0 87 LZO LZO DEPUY ORTHOPAEDICS, INC. NA SA103148

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention