BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR ACETABULAR CUPS 54

    MDR report key: 2840560 · Received November 20, 2012

    Report

    Report Number
    1818910-2012-22906
    Event Type
    Injury
    Date Received
    November 20, 2012
    Date of Event
    July 16, 2013
    Report Date
    August 16, 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
    NJ, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). LITIGATION ALLEGES PATIENT HAD PAIN AFTER ASR HIP IMPLANT. 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

    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

    DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    PATIENT SEEKING LEGAL ACTION.

    Description of Event or Problem · 1

    **UPDATE** - MEDICAL RECORDS RECEIVED (B)(4) 2013. REVISION OPERATIVE REPORT INDICATES THE FOLLOWING: PAIN; SCAR TISSUE; SMALL AMOUNT OF FLUID EXUDED FROM THE PSEUDOCAPSULE AREA; THE BONE OF RIM OF ACETABULUM SOMEWHAT THIN AND OF POOR QUALITY; SOME SOFT TISSUE IN THE PULVINAR WHICH WAS MINIMAL. THE INFORMATION RECEIVED DOES NOT CHANGE THE MDR DECISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR ACETABULAR CUPS 54 TOTAL HIP REPLACEMENT KWA DEPUY INTERNATIONAL 2195145

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Other