BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SNAP-RING FOR 52MM OD

    MDR report key: 959218 · Received December 4, 2007

    Report

    Report Number
    1818910-2007-04056
    Event Type
    Injury
    Date Received
    December 4, 2007
    Date of Event
    November 13, 2007
    Report Date
    November 13, 2007
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    KWB
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE CODE AND 510(K) HAVE NOT BEEN REPORTED AS THIS PRODUCT WAS SOLD AS A COMPONENT OF CATALOG NUMBER 124752000, LOT NUMBER 899981001 (DEVICE CODE 87 JDL, 510(K) K900832). EXAMINATION WAS NOT POSSIBLE, AS THE DEVICES WERE NOT RETURNED. A COMPLAINT DATABASE SEARCH FINDS NO OTHER REPORTED INCIDENTS AGAINST THE PROVIDED PRODUCT AND LOT CODES SINCE THEIR RELEASE FOR DISTRIBUTION. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT CONTRIBUTION TO THE REPORTED EVENT. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED. DEPUY CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS DISLOCATION IN ADDITION TO FRACTURE OF THE LOCKING RING AND LINER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SNAP-RING FOR 52MM OD LOCKING RING KWB DEPUY ORTHOPAEDICS, INC. NA 830530

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention