BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR ACETABULAR IMPLANT 56

    MDR report key: 2010012 · Received March 2, 2011

    Report

    Report Number
    1818910-2011-02733
    Event Type
    Injury
    Date Received
    March 2, 2011
    Date of Event
    February 17, 2011
    Report Date
    March 20, 2013
    Manufacturer
    DEPUY INTL LTD
    Product Code
    KWA
    PMA / PMN Number
    NA
    Removal / Correction Number
    Z- 1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    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. THE CORRECTION/REMOVAL REPORTING NUMBER LISTED APPLIES TO THE CORRESPONDING PRODUCT CODE SOLD DOMESTICALLY.

    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.

    Description of Event or Problem · 1

    LEFT. ASR XL. REASON(S) FOR REVISION: PAIN.

    Description of Event or Problem · 1

    THE PT WAS REVISED TO ADDRESS PAIN. BLACKENING OF THE SYNOVIAL MEMBRANE AND SURROUNDING TISSUE, AS WELL AS LOOSENING OF THE CORAIL STEM WERE FOUND INTRA-OPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR ACETABULAR IMPLANT 56 87KWA KWA DEPUY INTL LTD NA 2233154

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention