BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR ACETABULAR CUPS 56

    MDR report key: 2635599 · Received June 29, 2012

    Report

    Report Number
    1818910-2012-15678
    Event Type
    Injury
    Date Received
    June 29, 2012
    Date of Event
    June 19, 2012
    Report Date
    June 19, 2012
    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
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    **UPDATE** (B)(4) 2012 - LEGAL CLAIM RECEIVED. THE DATE OF IMPLANTATION WAS PROVIDED. THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE INVESTIGATION. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME.

    Additional Manufacturer Narrative · 1

    DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED.

    Additional Manufacturer Narrative · 1

    THE ASR PLATFORM WAS VOLUNTARILY RECALLED FROM THE MARKET IN (B)(6), 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

    DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS PAIN.

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS PAIN. **UPDATE** 9/21/2012- LEGAL CLAIM RECEIVED. THE DATE OF IMPLANTATION WAS PROVIDED (B)(6) 2008. THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE INVESTIGATION. UPDATE 01/07/2013 LITIGATION ALLEGED THE PATIENT SUFFERED SORENESS, DISCOMFORT, SNAPPING OF THE HIP IMPLANT, IMMOBILITY, WORSENING TREMOR, DIZZINESS, HEADACHES, TINNITUS, METALLIC TASTE IN THE PATIENT'S MOUTH, AND ELEVATED METAL ION LEVELS (MEASURED AT 9.7 MCG/L OF COBALT AND 0.9 MCG/L OF CHROMIUM) AS A RESULT OF THE IMPLANTED ASR HIP. THERE IS NO NEW INFORMATION THAT CHANGES THE OUTCOME OF THIS INVESTIGATION. **UPDATE** 2/6/2013 - PLAINTIFF'S PRELIMINARY DISCLOSURE FORM WAS RECEIVED, WHICH IDENTIFIED PART/LOT INFORMATION AND SIDE. THE COMPLAINT AND ASSOCIATED MDRS WERE UPDATED. THERE WAS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION.

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS PAIN. UPDATE LITIGATION ALLEGED THE PATIENT SUFFERED SORENESS, DISCOMFORT, SNAPPING OF THE HIP IMPLANT, IMMOBILITY, WORSENING TREMOR, DIZZINESS, HEADACHES, TINNITUS, METALLIC TASTE IN THE PATIENTS MOUTH, AND ELEVATED METAL ION LEVELS (MEASURED AT 9.7 MCG/L OF COBALT AND 0.9 MCG/L OF CHROMIUM) AS A RESULT OF THE IMPLANTED ASR HIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR ACETABULAR CUPS 56 ACETABULAR CUP HIP IMPLANT KWA DEPUY INTERNATIONAL 2564381

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention