BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 46

    MDR report key: 2002367 · Received February 18, 2011

    Report

    Report Number
    1818910-2011-02611
    Event Type
    Injury
    Date Received
    February 18, 2011
    Date of Event
    November 29, 2010
    Report Date
    January 19, 2011
    Manufacturer
    DEPUY INTERNATIONAL LTD. 8010379
    Product Code
    KWA
    PMA / PMN Number
    K040627
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    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

    NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    UPDATE SEP 14, 2017: MEDICAL RECORDS RECEIVED. AFTER REVIEW OF MEDICAL RECORDS FOR MDR REPORTABILITY, IN ADDITION TO WHAT WAS PREVIOUSLY REPORTED, REVISION NOTES REPORTED PAIN, 50 ML OF STRAW-COLORED FLUID AND EXTREMELY HYPERTROPHIC PSEUDOCAPSULE. ADDED COMPLAINANT INFORMATION AND SLEEVE PRODUCT DUE TO PAIN. THIS COMPLAINT WAS UPDATED ON OCT 12, 2017.

    Description of Event or Problem · 1

    PT WAS REVISED TO ADDRESS ACETABULAR LOOSENING. MEDICAL RECORDS WERE RECEIVED. PRODUCT AND LOT INFO WAS UPDATED. THE FEMORAL HEAD WAS ADDED TO THE COMPLAINT. OPERATIVE REPORT FROM THE REVISION STATES THE POST PROCEDURE DIAGNOSIS AS PROBABLE METAL HYPERSENSITIVITY REACTION, LEFT TOTAL HIP ARTHROPLASTY. PROBABLE ALVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR UNI FEMORAL IMPL SIZE 46 HIP FEMORAL HEAD KWA DEPUY INTERNATIONAL LTD. 8010379 NA 2403170

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention