BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR ACETABULAR CUPS 56

    MDR report key: 2241585 · Received September 9, 2011

    Report

    Report Number
    1818910-2011-17760
    Event Type
    Injury
    Date Received
    September 9, 2011
    Report Date
    July 26, 2013
    Manufacturer
    DEPUY INTERNATIONAL
    Product Code
    KWA
    PMA / PMN Number
    PK040627
    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

    UPDATE: (B)(6) 2013 - AMENDED LITIGATION PAPERS RECEIVED. ORIGINAL LITIGATION INDICATED THAT THE PATIENT WAS IMPLANTED WITH ASR; HOWEVER, AMENDED LITIGATION ALLEGES THAT THE PATIENT WAS IMPLANTED WITH PINNACLE. THE PRODUCTS HAVE BEEN UPDATED AND FOLLOW-UPS CREATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME.

    Additional Manufacturer Narrative · 1

    DEPUY STILL CONSIDERS THIS COMPLAINT CLOSED.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE: PATIENT WAS IMPLANTED WITH A DEPUY ASR HIP IMPLANT ON HIS LEFT SIDE ON OR ABOUT (B)(6), 2008. HE EXPERIENCED PAIN AND SUFFERING IN HIS HIP AND LOWER EXTREMITY AND IMPAIRED MOBILITY. PATIENT HAS NOT YET SCHEDULED A REVISION SURGERY.

    Description of Event or Problem · 1

    UPDATE: (B)(4) 2013. PFS WAS RECEIVED FROM LEGAL, MEDICAL RECORDS WERE RECEIVED FROM LEGAL, AND PART/LOT INFORMATION WAS IDENTIFIED. ALTHOUGH AMENDED LITIGATION WAS RECEIVED CLAIMING THE PATIENT HAD PINNACLE MEDICAL RECORDS AND IMPLANT RECORDS SHOW THE PATIENT HAD ASR. RECORDS ARE AVAILABLE FOR FURTHER REVIEW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR ACETABULAR CUPS 56 ACETABULAR SHELL KWA DEPUY INTERNATIONAL 2601937

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention