BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR ACETABULAR CUPS 50

    MDR report key: 2052690 · Received April 7, 2011

    Report

    Report Number
    1818910-2011-06123
    Event Type
    Injury
    Date Received
    April 7, 2011
    Date of Event
    January 21, 2011
    Report Date
    January 23, 2012
    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
    NJ, US
    Reporter Occupation
    ATTORNEY

    Narratives

    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

    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

    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

    CORRECTED/UPDATED DATA: (DATE OF REPORT); (DATE RECEIVED BY MANUFACTURER); (DATE OF MANUFACTURE). DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE PT BEGAN EXPERIENCING DIFFICULTY WALKING INCLUDING BUT NOT LIMITED TO LOSS OF BALANCE, STUMBLING, PAIN DOWN THE BACK OF HER LEGS, GROIN, RIGHT SIDE OF HIP, AND BUTTOCKS. IT IS FURTHER ALLEGED PT UNDERWENT EXTENSIVE MEDICAL TREATMENT AND THAT PT CONTINUED IN HER STATE OF SEVERE PAIN AND DISCOMFORT, AND REMAINED SEVERELY LIMITED IN HER ABILITY TO CARRY OUT NORMAL FUNCTIONS, INCLUDING SLEEP. LITIGATION PAPERS ALSO ALLEGE THAT PT'S PHYSICIAN TOOK X-RAYS AND PERFORMED BLOOD TESTS RELEVANT TO HER PROSTHESIS. THE TESTS OF PT'S BLOOD REVEALED THAT IT HAD BEEN CONTAMINATED WITH CHROMIUM AND COBALT. THE X-RAYS REVEALED THE DEVICE HAD SHIFTED POSITION AND BECAME DISLOCATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR ACETABULAR CUPS 50 ACETABULAR CUP HIP IMPLANT KWA DEPUY INTERNATIONAL, LTD. NA 2549799

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention