BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR ACETABULAR IMPLANT 56

    MDR report key: 2233966 · Received September 6, 2011

    Report

    Report Number
    1818910-2011-16991
    Event Type
    Injury
    Date Received
    September 6, 2011
    Date of Event
    August 24, 2011
    Report Date
    March 27, 2026
    Manufacturer
    DEPUY INTERNATIONAL
    Product Code
    KWA
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    PATIENT
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THERE IS NO NEW INFORMATION TO REPORT AT THIS TIME. PER FDA REQUEST, THIS FOLLOW-UP 2 IS BEING SUBMITTED TO FILL THE GAP IN REPORT SEQUENCE NUMBERS.

    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. THE CORRECTION/REMOVAL REPORTING NUMBER LISTED APPLIES TO THE CORRESPONDING PRODUCT CODE SOLD DOMESTICALLY.

    Description of Event or Problem · 1

    THE PATIENT WAS REVISED TO ADDRESS GROIN PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    13313 ASR ACETABULAR IMPLANT 56 PROSTHESIS, HIP, SEMI-CONSTRAINED (METAL UNCEMENTED ACETABULAR COMPONENT) KWA DEPUY INTERNATIONAL 2198127

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention