BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEPUY ASR 50 CUP

    MDR report key: 2121247 · Received June 1, 2011

    Report

    Report Number
    1818910-2011-09311
    Event Type
    Injury
    Date Received
    June 1, 2011
    Date of Event
    May 2, 2011
    Report Date
    May 2, 2011
    Manufacturer
    DEPUY INTERNATIONAL, LTD.
    Product Code
    KWA
    PMA / PMN Number
    NA
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    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 REPORT STATES: PATIENT WAS REVISED TO ADDRESS PAIN AND ACETABULAR LOOSENING. DOI: 2 YEARS AGO - DOR: (B)(6) 2011 (RIGHT SIDE). UPDATE - (B)(4) 2011 - LITIGATION PAPERS ALLEGE PATIENT SUFFERED THE FOLLOWING PERSONAL AND ECONOMIC INJUR(IES) AS A RESULT OF THE IMPLANTATION WITH THE ASR HIP IMPLANTS: SIGNIFICANT AND PERMANENT PERSONAL INJURY INCLUDING BUT NOT LIMITED TO RELEASE OF METAL AND METAL IONS INTO HER BODY TISSUES AND BLOOD, PAIN, DISTRESS, ANXIETY AND LIMITATION OF MOVEMENT. IT IS ALSO ALLEGED PATIENT SUSTAINED SIGNIFICANT ECONOMIC DAMAGE THROUGH PAST AND FUTURE LOST WAGES AND PAST AND FUTURE IMPAIRMENT OF EARNING CAPACITY, INTERFERING WITH WORK AND DAILY LIVING ACTIVITIES AND INTERFERENCE WITH HER ABILITY TO PERFORM OTHER ECONOMICALLY PRODUCTIVE ENTERPRISES. FEMORAL HEAD ADDED TO COMPLAINT. DOI: (B)(6) 2009. PATIENT IS A RESIDENT OF (B)(6). 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.

    Description of Event or Problem · 1

    PT WAS REVISED TO ADDRESS PAIN AND ACETABULAR LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN DEPUY ASR 50 CUP 87KWA KWA DEPUY INTERNATIONAL, LTD. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention