BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR ACETABULAR CUPS 60

    MDR report key: 2860910 · Received December 6, 2012

    Report

    Report Number
    1818910-2012-26951
    Event Type
    Injury
    Date Received
    December 6, 2012
    Date of Event
    November 19, 2012
    Report Date
    December 31, 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
    MT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEPUY STILL CONSIDERS THIS INVESTIGATION 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. (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.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    **UPDATE** (B)(4) 2013 - PLAINTIFF¿S PRELIMINARY DISCLOSURE FORM WAS RECEIVED, WHICH IDENTIFIED DOB INFORMATION. LOT FOR PRODUCTS WAS IDENTIFIED ON PATIENT STICKER SHEET. THE COMPLAINT AND ASSOCIATED MDRS WERE UPDATED. COMPLAINT WAS UPDATED ON (B)(4) 2013.

    Description of Event or Problem · 1

    UPDATE: (B)(4) 2013 - MEDICAL RECORDS RECEIVED. PATIENT WAS REVISED TO ADDRESS HETEROTOPIC OSSIFICATION, YELLOWISH GREEN FLUID CONSISTENT WITH ADVERSE REACTION TO METAL DEBRIS, CORROSIVE CHANGES ON THE TRUNNION, NO SIGNIFICANT BONY INGROWTH ON THE ACETABULAR CUP AND OSTEOLYSIS. THE STEM AND SLEEVE HAVE BEEN ADDED TO THE COMPLAINT. THIS COMPLAINT WAS UPDATED ON: (B)(4) 2014.

    Description of Event or Problem · 1

    PATIENT WAS REVISED DUE TO PAIN, ELEVATED COCR LEVELS AND SMALL FLUID COLLECTION. (RIGHT HIP).

    Description of Event or Problem · 1

    UPDATE: (B)(6) 2013 - LITIGATION PAPERS RECEIVED. LITIGATION ALLEGES DAMAGE TO BONE AND TISSUE AND METALLOSIS. THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR ACETABULAR CUPS 60 ACETABULAR CUP KWA DEPUY INTERNATIONAL 2158472

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention