BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR 300 SPIKED CUP SIZE 60

    MDR report key: 1923840 · Received December 8, 2010

    Report

    Report Number
    1818910-2010-09449
    Event Type
    Injury
    Date Received
    December 8, 2010
    Report Date
    November 8, 2010
    Manufacturer
    DEPUY INTERNATIONAL, LTD.
    Product Code
    KWA
    PMA / PMN Number
    K073413
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, 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.

    Description of Event or Problem · 1

    MEDWATCH REPORT STATES: ELDERLY PT WITH HIP PAIN AND DEGENERATIVE JOINT DISEASE, UNDERWENT TOTAL HIP ARTHROPLASTY AT ANOTHER FACILITY IN THE (B)(4)2009. THE PT WAS SEEN IN THE EARLY (B)(4) 2010 WITH INCREASING HIP PAIN. MRI SHOWED PSEUDOTUMOR AND LARGE FLUID COLLECTION. THE FLUID WAS DRAINED AND A HIP ACETABULAR REVISION SURGERY WAS CARRIED OUT SEVERAL MONTHS AFTER. HEALTH PROFESSIONAL'S IMPRESSION - METAL ON METAL REACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR 300 SPIKED CUP SIZE 60 87KWA KWA DEPUY INTERNATIONAL, LTD. NA 2786302

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention