BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEPUY DURALOC 28X62 10D HYLAMER LINER

    MDR report key: 1923638 · Received December 9, 2010

    Report

    Report Number
    1818910-2010-08726
    Event Type
    Injury
    Date Received
    December 9, 2010
    Date of Event
    November 9, 2010
    Report Date
    November 9, 2010
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    LPH
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LINER ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. IT WAS REPORTEDLY DISCARDED BY THE HOSPITAL. THE PRODUCT AND LOT CODE WAS NOT PROVIDED. IT IS NOT POSSIBLE TO DRAW ANY CONCLUSIONS REGARDING THE REPORTED MATERIAL WEAR WITHOUT PRODUCT EXAMINATION. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT OR ADDITIONAL INFORMATION BE REC'D TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Description of Event or Problem · 1

    PT WAS REVISED TO ADDRESS INABILITY, EXCESSIVE WEAR, AND OSTEOLYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN DEPUY DURALOC 28X62 10D HYLAMER LINER TOTAL HIP PROSTHESIS LPH DEPUY ORTHOPAEDICS, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention