BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR ACETABULAR CUPS 54

    MDR report key: 2163416 · Received July 8, 2011

    Report

    Report Number
    1818910-2011-12442
    Event Type
    Injury
    Date Received
    July 8, 2011
    Report Date
    June 18, 2013
    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
    CO, US
    Reporter Occupation
    ATTORNEY

    Narratives

    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

    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

    DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED.

    Additional Manufacturer Narrative · 1

    DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE: ON OR ABOUT (B)(6) 2009, PATIENT WAS IMPLANTED WITH A DEPUY ASR HIP ON HIS RIGHT SIDE. SUBSEQUENT TO HIS SURGERY, PATIENT BEGAN HAVING PAIN IN HIS RIGHT HIP, WHICH OVER TIME HAS BECOME PROGRESSIVELY WORSE AND NOW EXCEEDS THE PAIN HE HAD BEFORE HIS HIP REPLACEMENT SURGERY. IT IS REASONABLY CERTAIN THAT PATIENT WILL HAVE TO UNDERGO REVISION SURGERY. UPDATE: (B)(6) 2012 - THE SALES REP HAS REPORTED THE REVISION SURGERY. PATIENT WAS REVISED DUE TO PAIN AND FLUID BUILD-UP.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE: ON OR ABOUT (B)(6) 2009, PT WAS IMPLANTED WITH A DEPUY ASR HIP ON HIS RIGHT SIDE. SUBSEQUENT TO HIS SURGERY, PT BEGAN HAVING PAIN IN HIS RIGHT HIP, WHICH OVER TIME HAS BECOME PROGRESSIVELY WORSE AND NOW EXCEEDS THE PAIN HE HAD BEFORE HIS HIP REPLACEMENT SURGERY. IT IS REASONABLY CERTAIN THAT PT WILL HAVE TO UNDERGO REVISION SURGERY.

    Description of Event or Problem · 1

    UPDATE: - REVISION OPERATIVE REPORT RECEIVED (B)(6) 2013 . THE REVISION OPERATIVE REPORT INDICATES THE FOLLOWING: VERY CLOUDY MILK-COLORED SYNOVIAL FLUID CONSISTENT WITH AN ADVERSE SOFT TISSUE REACTION TO METAL-ON-METAL WEAR; SCORING OF THE ACETABULAR SHELL; CORROSION ON THE FEMORAL NECK TAPER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR ACETABULAR CUPS 54 87KWA KWA DEPUY INTERNATIONAL, LTD. NA 2900358

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention