BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR ACETABULAR CUPS 52

    MDR report key: 2780752 · Received October 10, 2012

    Report

    Report Number
    1818910-2012-23428
    Event Type
    Injury
    Date Received
    October 10, 2012
    Report Date
    September 14, 2012
    Manufacturer
    DEPUY INTERNATIONAL LTD - 8010379
    Product Code
    KWA
    PMA / PMN Number
    K040627
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    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. (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.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY ==> THIS HIP REPLACEMENT PLATFORM WAS VOLUNTARILY RECALLED FROM THE MARKET AND THE PRODUCT CODES ARE NOW CONSIDERED INACTIVE. DEPUY CONSIDERS THE INVESTIGATION CLOSED. 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

    PLAINTIFF PRELIMINARY DISCLOSURE FORM RECEIVED WITH STICKER SHEET FOR PART AND LOT NUMBERS. PATIENT HAS NOT BEEN REVISED. LITIGATION HAS NOT BEEN RECEIVED AT THIS POINT IN TIME. (B)(6) 2012 - LITIGATION PAPERS RECEIVED, PAPERS ALLEGE THAT THE PATIENT EXPERINCES PROGRESSIVELY SEVERE PAIN, SORENESS AND DISCOMFORT AND HAD EXCESSIVELY HIGH METAL ION LEVELS.

    Description of Event or Problem · 1

    PFS AND MEDICAL RECORDS RECEIVED. IN ADDITION TO WHAT WERE PREVIOUSLY ALLEGED, PFS ALLEGES TISSUE AND BONE DAMAGE, LIMITED RANGE OF MOTION, WALKING DIFFICULTY AND LIMITED MOBILITY. AFTER REVIEW OF MEDICAL RECORDS FOR MDR REPORTABILITY THE LABORATORY VALUES FOR COBALT/CHROMIUM IS BELOW 7PPB. CLINIC VISIT NOTES REPORTED THAT THE LEFT HIP DEMONSTRATES SEVERE DJD AND THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR ACETABULAR CUPS 52 ACETABULAR CUP KWA DEPUY INTERNATIONAL LTD - 8010379 2199312

    Patients

    Seq Age Sex Outcome Treatment
    1 Other