BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 49

    MDR report key: 2230029 · Received August 31, 2011

    Report

    Report Number
    1818910-2011-16863
    Event Type
    Injury
    Date Received
    August 31, 2011
    Date of Event
    June 17, 2010
    Report Date
    March 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
    AL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE ASR PLATFORM WAS VOLUNTARILY RECALLED FROM THE MARKET IN (B)(4) 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

    PATIENT FACT SHEET (PFS) FORM RECEIVED WHICH IDENTIFIED THE PART/LOT INFORMATION. THERE IS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION. DEPUY STILL CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE PATIENT SUFFERED AND CONTINUES TO SUFFER POTENTIAL COBALT AND/OR CHROMIUM POISONING, CONSTANT PAIN, NECESSARY CONTINUED MEDICAL TREATMENT, LOST INCOME, NUMEROUS DOCTORS VISITS, NUMEROUS SURGERIES INCLUDING REVISION SURGERY, INFECTIONS, ANXIETY, FEAR AND OTHER ECONOMIC AND EMOTIONAL DAMAGES. IT IS FURTHER ALLEGED PATIENT COULD NOT HAVE KNOWN HE WAS INJURED BY EXCESSIVE LEVELS OF CHROMIUM AND COBALT UNTIL AFTER THE DATE HE HAD HIS BLOOD DRAWN AND HE WAS ADVISED OF THE RESULTS OF SAID BLOODWORK.

    Description of Event or Problem · 1

    UPDATE REC'D 3/29/2013- PPD AND MEDICAL RECORDS RECEIVED. A CORRECT DOR WAS PROVIDED. AFTER REVIEW OF THE MEDICAL RECORDS FOR MDR REPORTABILITY, THE REVISION NOTE FROM 6/17/2010 DIDN'T INDICATE ANY INFECTION AS LITIGATION ALLEGED. THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE EXISTING MDR DECISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR UNI FEMORAL IMPL SIZE 49 FEMORAL HEAD KWA DEPUY INTERNATIONAL 2986827

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Required Intervention