BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEPUY ACETABULAR REAMER

    MDR report key: 1250787 · Received December 2, 2008

    Report

    Report Number
    1818910-2008-05763
    Event Type
    Injury
    Date Received
    December 2, 2008
    Date of Event
    November 3, 2008
    Report Date
    November 3, 2008
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    LXH
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION WAS NOT POSSIBLE, AS THE INSTRUMENT WAS NOT RETURNED. THE PROD AND LOT CODE WAS ALSO NOT PROVIDED. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PROD ERROR/CONTRIBUTION TO THE REPORTED EVENT WITH THE INFO AVAILABLE. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED.

    Description of Event or Problem · 1

    DURING THE PRIMARY SURGERY THE SHELL WAS IMPACTED INTO THE ACETABULUM AND THE POSTERIOR WALL GAVE WAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN DEPUY ACETABULAR REAMER 87LXH LXH DEPUY ORTHOPAEDICS, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR