BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNIDENTIFIED ACETABULAR CUP

    MDR report key: 2982346 · Received February 28, 2013

    Report

    Report Number
    1818910-2013-12911
    Event Type
    Injury
    Date Received
    February 28, 2013
    Date of Event
    January 31, 2013
    Report Date
    January 31, 2013
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. 1818910
    Product Code
    KWA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    THE REPORTING INDICATES THE REASON FOR REVISION AS PAIN, DISLOCATION AND POLY WEAR. EXAMINATION OF THE RETURNED DEVICES FINDS EVIDENCE THAT THE LINER HAD IN FACT DISASSOCIATED FROM THE ACETABULAR CUP. IT IS SUSPECTED THAT THE DEVICES WERE NOT FULLY ENGAGED WHEN FIRST IMPLANTED, LATER LEADING TO THE DISASSOCIATION NOW IDENTIFIED. FOLLOW-UP FOR ADDITIONAL EVENT INFORMATION WAS CONDUCTED UTILIZING WORK INSTRUCTION WI-7915 APPENDIX A; REV. D. NO ADDITIONAL INFORMATION WAS OBTAINED. DEVICE EVALUATION DID NOT IDENTIFY OR VERIFY PRODUCT ERROR WITH REGARD TO THE REPORT. THROUGH PRODUCT TRENDING, THE OCCURRENCE RATE FOR THIS TYPE OF FAILURE IS KNOWN TO BE VERY SMALL. BASED ON THE INVESTIGATION, PRODUCT CONTRIBUTION WAS NOT IDENTIFIED AND A NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS PAIN, DISLOCATION, AND EXTENSIVE POLY WEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    85565 UNIDENTIFIED ACETABULAR CUP ACETABULAR CUP KWA DEPUY ORTHOPAEDICS, INC. 1818910 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention