BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR ACETABULAR CUPS 60

    MDR report key: 2052683 · Received April 7, 2011

    Report

    Report Number
    1818910-2011-06126
    Event Type
    Injury
    Date Received
    April 7, 2011
    Report Date
    March 8, 2011
    Manufacturer
    DEPUY INTERNATIONAL, LTD.
    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)(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

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    CORRECTED: EVENT/PROBLEM DESCRIPTION, BRAND NAME, DEVICE PRODUCT CODE, CATALOG #/LOT #, IMPLANT DATE, PMA/510(K) #, MANUFACTURE DATE. DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE: PATIENT BEGAIN TO SUFFER FROM PAIN AND DISCOMFORT IN HIS HIP AND GROIN WHICH HAS INCREASED OVER TIME. PATIENT SUFFERED AND CONTINUES TO SUFFER ADDITIONAL SYMPTOMS INCLUDING, BUT NOT LIMITED TO SENSATION OF MISALIGNMENT, WEAKNESS, DECREASED RANGE OF MOTION, AND DIFFICULTY WITH ACTIVITIES OF DAILY LIVING. PATIENTS IMPLANT MAKES CLICKING AND POPPING TYPE NOISES, AND HAS EXHIBITED THE SYMPTOMS OF A LOOSE IMPLANT. PATIENTS BLOOD LEVELS WERE TESTED FOR METAL IONS. RESULTS AT THAT TIME REVEALED A COBALT LEVEL OF 8. MRI REVEALED LARGE FLUID SACKS AND PSEUDO TUMORS. PHYSICIAN ADVISED HE AND HIS WIFE THAT IT WAS IMPERATIVE THAT THE IMPLANT BE REMOVED IMMEDIATELY. PATIENT SUFFERS FROM SUBSTANTIALLY ELEVATED AND POTENTIALLY TOXIC CHROMIUM AND COBALT METAL IONS IN HIS BLOOD STREAM. PATIENT SUFFERED FROM RASHES ON HIS BACK, SOME AS LARGE AS TENNIS BALLS. UPDATE: (B)(4) 2011 - MEDICAL RECORDS WERE RECEIVED. THE REVISION OPERATIVE REPORT INDICATES THE PATIENT WAS REVISED PAIN, LOOSENING AND METALLOSIS. UPDATE: (B)(4) 2012 - PLAINTIFF'S PRELIMINARY DISCLOSURE FORM WAS RECEIVED, WHICH IDENTIFIED PART/LOT INFORMATION AND DATE OF IMPLANT. 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

    LITIGATION PAPERS ALLEGE: PT BEGAN TO SUFFER FROM PAIN AND DISCOMFORT IN HIS HIP AND GROIN WHICH HAS INCREASED OVER TIME. PT SUFFERED AND CONTINUES TO SUFFER ADD'L SYMPTOMS INCLUDING, BUT NOT LIMITED TO SENSATION OF MISALIGNMENT, WEAKNESS, DECREASED RANGE OF MOTION, AND DIFFICULTY WITH ACTIVITIES OF DAILY LIVING. PT'S IMPLANT MAKES CLICKING AND POPPING TYPE NOISES, AND HAS EXHIBITED THE SYMPTOMS OF A LOOSE IMPLANT. PT'S BLOOD LEVELS WERE TESTED FOR METAL IONS. RESULTS AT THAT TIME REVEALED A COBALT LEVEL OF 8. MRI REVEALED LARGE FLUID "SACKS" AND PSEUDO TUMORS. PHYSICIAN ADVISED HIM AND HIS WIFE THAT IT WAS IMPERATIVE THAT THE IMPLANT BE REMOVED IMMEDIATELY. PT SUFFERS FROM SUBSTANTIALLY ELEVATED AND POTENTIALLY TOXIC CHROMIUM AND COBALT METAL IONS IN HIS BLOOD STREAM. PT SUFFERED FROM RASHES ON HIS BACK, SOME AS LARGE AS TENNIS BALLS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR ACETABULAR CUPS 60 NONE KWA DEPUY INTERNATIONAL, LTD. NA 2158474

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention