BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEPUY ACETABULAR CUP

    MDR report key: 3253558 · Received July 30, 2013

    Report

    Report Number
    1818910-2013-22423
    Event Type
    Injury
    Date Received
    July 30, 2013
    Date of Event
    July 15, 2013
    Report Date
    July 15, 2013
    Manufacturer
    1818910 DEPUY ORTHOPAEDICS, INC.
    Product Code
    KXA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, 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

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. EXAMINATION OF THE REPORTED DEVICES WAS NOT POSSIBLE AS THEY WERE NOT RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS AND/OR A COMPLAINT DATABASE SEARCH WAS NOT POSSIBLE AS THE PRODUCT AND LOT CODES REQUIRED WERE NOT PROVIDED. MEDICAL RECORDS AND X-RAYS WERE REVIEWED, CONFIRMING DISASSOCIATION AND FEMORAL HEAD ECCENTRIC LOADING. THE REVIEW COULD NOT VERIFY ANY PRODUCT CONTRIBUTION TO THE REPORTED EVENT. THE INVESTIGATION CAN DRAW NO CONCLUSION WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO DETERMINE ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION HAS NOT BEEN INDICATED.

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS DISASSOCIATION OF THE LINER FROM THE CUP. THE PATIENT HAD ALSO SUBLUXED AND DISLOCATED SEVERAL TIMES IN THE PAST THREE YEARS AND NEVER SAW A DOCTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    354637 UNKNOWN DEPUY ACETABULAR CUP ACETABULAR CUP KXA 1818910 DEPUY ORTHOPAEDICS, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention