BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR ACETABULAR IMPLANT 56

    MDR report key: 2261251 · Received September 23, 2011

    Report

    Report Number
    1818910-2011-18965
    Event Type
    Injury
    Date Received
    September 23, 2011
    Date of Event
    June 7, 2011
    Report Date
    April 8, 2013
    Manufacturer
    DEPUY INTERNATIONAL
    Product Code
    KWA
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PATIENT

    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).

    Additional Manufacturer Narrative · 1

    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

    CORRECTED/UPDATED DATA: (DATE OF REPORT); (EVENT DESCRIPTION); (MANUFACTURER); (DEVICE AVAILABILITY); DATE RECEIVED BY MANUFACTURER). DEPUY CONSIDERS THIS INVESTIGATION CLOSED. SHOULD THE PRODUCT OR ADDITIONAL INFORMATION THAT CHANGES THIS CONCLUSION BE RECEIVED, THE INVESTIGATION WILL BE REOPENED.

    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. THE CORRECTION/REMOVAL REPORTING NUMBER LISTED APPLIES TO THE CORRESPONDING PRODUCT CODE SOLD DOMESTICALLY. OTHER TEXT: NOT RETURNED.

    Description of Event or Problem · 1

    REASON(S) FOR REVISION: UNKNOWN.

    Description of Event or Problem · 1

    REASON(S) FOR REVISION: PAIN.

    Description of Event or Problem · 1

    ASR REVISION; ASR XL ACETABULAR SYSTEM - RIGHT HIP; REASON FOR REVISION: INFECTION (TESTED AND POSITIVE CULTURE CONFIRMED).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR ACETABULAR IMPLANT 56 ACETABULAR CUP IMPLANT KWA DEPUY INTERNATIONAL 2357111

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention