BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 49

    MDR report key: 3150823 · Received June 6, 2013

    Report

    Report Number
    1818910-2013-18335
    Event Type
    Injury
    Date Received
    June 6, 2013
    Date of Event
    June 5, 2013
    Report Date
    December 12, 2013
    Manufacturer
    DEPUY INTL., LTD. - 8010379
    Product Code
    KWA
    PMA / PMN Number
    PK040627
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED.

    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. REF. (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 COMPLAINT CLOSED.

    Additional Manufacturer Narrative · 1

    THERE IS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION. THE COMPLAINT IS CONSIDERED CLOSED.

    Description of Event or Problem · 1

    **UPDATE** (B)(4) 2013 - SALES REP REPORTED PATIENT UNDERWENT REVISION PROCEDURE DUE TO ASEPTIC LOOSENING OF THE ACETABULAR CUP. THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE OUTCOME OF THE INVESTIGATION.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE PAIN AND LIMITED MOBILITY. COMMENT: DUE TO LITIGATION DISCUSSING THE ISSUES OF METAL-ON-METAL, WE ARE CURRENTLY REPORTING THE ACETABULAR CUP AND FEMORAL HEAD. SHOULD WE RECEIVE ADDITIONAL INFORMATION, WE WILL UPDATE ACCORDINGLY.

    Description of Event or Problem · 1

    UPDATE: (B)(6) 2013 - MEDICAL RECORDS WERE OBTAINED. MEDICAL RECORDS INDICATE PATIENT WAS REVISED DUE TO INDURATION TO THE DEEP FASCIAL TISSUES, WHICH HAD A NEAR NECROTIC APPEARANCE, SLIGHT GRAY FLUID, HETEROTOPIC OSSIFICATION, TRUNNIONOSIS, AND A THICKWALLED PSEUDOTUMOR. THE INFORMATION RECEIVED DOES NOT CHANGE THE MDR DECISION. THE COMPLAINT WAS UPDATED ON: (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    251199 ASR UNI FEMORAL IMPL SIZE 49 TOTAL HIP REPLACEMENT KWA DEPUY INTL., LTD. - 8010379 2149603

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other| R