BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 47

    MDR report key: 2349089 · Received November 28, 2011

    Report

    Report Number
    1818910-2011-24308
    Event Type
    Injury
    Date Received
    November 28, 2011
    Report Date
    January 15, 2014
    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
    ATTORNEY

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    DEPUY STILL 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

    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

    LITIGATION PAPERS ALLEGE: PATIENT WAS IMPLANTED WITH A DEPUY ASR HIP IMPLANT ON HIS RIGHT HIP ON OR ABOUT (B)(6), 2009. PATIENT EXPERIENCED PAIN, SORENESS, AND DISCOMFORT; DIFFICULTY WALKING, SLEEPING, AND PERFORMING ROUTINE ACTIVITIES; INABILITY TO LEAD A NORMAL LIFE; EXTREMELY ELEVATED METAL IONS LEVELS, MEASURED AT 188 MCG/L OF COBALT AND 58.2 MCG/L OF CHROMIUM PRE-REVISION. PATIENT HAS SCHEDULED AN EXPLANTATION OF THE ASR HIP IMPLANT FOR (B)(6), 2011.

    Description of Event or Problem · 1

    UPDATE: (B)(4) 2014- MEDICAL RECORDS RECEIVED. PATIENT WAS REVISED TO ADDRESS GREY STAINED BURSAL THICKENING.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE: PATIENT WAS IMPLANTED WITH A DEPUY ASR HIP IMPLANT ON HIS RIGHT HIP ON OR ABOUT (B)(6), 2009. PATIENT EXPERIENCED PAIN, SORENESS, AND DISCOMFORT; DIFFICULTY WALKING, SLEEPING, AND PERFORMING ROUTINE ACTIVITIES; INABILITY TO LEAD A NORMAL LIFE; EXTREMELY ELEVATED METAL IONS LEVELS, MEASURED AT 188 MCG/L OF COBALT AND 58.2 MCG/L OF CHROMIUM PRE-REVISION. PATIENT HAS SCHEDULED AN EXPLANTATION OF THE ASR HIP IMPLANT FOR (B)(6), 2011. ***UPDATE: (B)(6) 2011 - THE SALES REP HAS ALSO REPORTED THE REVISION SURGERY. REPORT STATES THAT PATIENT WAS REVISED DUE TO PAIN AND METALLOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR UNI FEMORAL IMPL SIZE 47 FEMORAL HEAD KWA DEPUY INTERNATIONAL 2764862

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention