BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR ACETABULAR CUPS 50

    MDR report key: 2932595 · Received January 29, 2013

    Report

    Report Number
    1818910-2013-01619
    Event Type
    Injury
    Date Received
    January 29, 2013
    Report Date
    August 29, 2013
    Manufacturer
    DEPUY INTERNATIONAL
    Product Code
    KWA
    PMA / PMN Number
    K040627
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    DEPUY STILL CONSIDERS THIS COMPLAINT CLOSED.

    Additional Manufacturer Narrative · 1

    THE ASR PLATFORM WAS VOLUNTARILY RECALLED FROM THE MARKET IN AUGUST 2010, AND THE ASR PRODUCT CODES ARE NOW CONSIDERED INACTIVE. FURTHER INVESTIGATION OF THIS INDIVIDUAL INCIDENT WILL NOT BE UNDERTAKEN, AS THERE IS AN ONGOING INVESTIGATION REGARDING THE ROOT CAUSE(S) AND/OR CORRECTIVE ACTIONS. REF. (B)(4). DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED. (B)(4).

    Description of Event or Problem · 1

    **UPDATE** - MEDICAL RECORDS RECEIVED (B)(4) 2013. REVISION OPERATIVE REPORT INDICATES THE FOLLOWING: SIGNIFICANT METALLOSIS AS WELL AS BURSITIS WITH FLUID AS WELL AS NECROTIC AND PSEUDOTUMOR TYPE THICK BURSITIS TISSUE INVADING THE BURSAL REGION; SIGNIFICANT AMOUNTS OF CLEAR, SLIGHTLY METALLOSIS-TINGED FLUID WAS FOUND; SIGNIFICANT AMOUNTS OF PSEUDOTUMOR SYNOVITIS; METALLOSIS AND NECROTIC TISSUE THROUGHOUT THE AREA OF THE HIP, THE POSTERIOR CAPSULE AND ALL QUADRANTS OF THE ACETABULUM. THE INFORMATION RECEIVED DOES NOT CHANGE THE MDR DECISION.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE THE PATIENT EXPERIENCED DEBILITATING PAIN AND DISCOMFORT IN HIPS AND LEGS, THEREBY INTERFERING WITH THE PATIENTS ABILITY TO PERFORM ACTIVITIES OF DAILY LIVING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    39558 ASR ACETABULAR CUPS 50 ACETABULAR CUP HIP IMPLANT KWA DEPUY INTERNATIONAL 2987505

    Patients

    Seq Age Sex Outcome Treatment
    1 Other