BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 46

    MDR report key: 3050867 · Received April 10, 2013

    Report

    Report Number
    1818910-2013-04821
    Event Type
    Injury
    Date Received
    April 10, 2013
    Report Date
    October 25, 2013
    Manufacturer
    DEPUY INTERNATIONAL
    Product Code
    KWA
    PMA / PMN Number
    PK040627
    Removal / Correction Number
    Z1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED.

    Additional Manufacturer Narrative · 1

    DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED.

    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.

    Description of Event or Problem · 1

    **UPDATE** (B)(4) 2013 - SALES REP REPORTED REVISION OF RIGHT HIP.

    Description of Event or Problem · 1

    LITIGATION ALLEGES PATIENT HAD ACETABULAR CUP DETACHED, DISCONNECTED AND CREATED METALLIC DEBRIS, AND/OR LOOSENED FROM ACETABULUM, CAUSED SEVERE PAIN AND INHIBITED ABILITY TO WALK AFTER ASR HIP IMPLANT. **UPDATE** (B)(4) 2013 - ADDITIONAL LITIGATION PAPERS RECEIVED (B)(4) 2013 AND ATTACHED. THERE IS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION. **UPDATE**- (B)(4) 2013-SALES REP REPORTED REVISION OF RIGHT HIP. THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE OUTCOME OF THE INVESTIGATION. **UPDATE** (B)(4) 2013 - PLAINTIFF¿S PRELIMINARY DISCLOSURE FORM WAS RECEIVED, WHICH IDENTIFIED DOB INFORMATION. PATIENTS STICKER SHEET WAS PROVIDED AND PART AND LOT WERE UPDATED. THE COMPLAINT AND ASSOCIATED MDRS WERE UPDATED.

    Description of Event or Problem · 1

    UPDATE REC¿D (B)(4) 2013 ¿ MEDICAL RECORDS WERE RECEIVED. THE COMPLAINT WAS UPDATED ON (B)(4) 2013. REVISION OPERATIVE REPORT INDICATES THE FOLLOWING: ADVERSE TISSUE REACTION; A LOT OF SYNOVIAL FLUID AND METAL DEBRIS; SIGNIFICANT DISRUPTION OF THE POSTERIOR CAPSULAR AND SURROUNDING CAPSULAR STRUCTURES; SOME CORROSION ON THE TRUNNION. ADAPTOR SLEEVE, FEMORAL STEM, AND STEM SLEEVE ADDED TO COMPLAINT.

    Description of Event or Problem · 1

    LITIGATION ALLEGES PATIENT HAD ACETABULAR CUP DETACHED, DISCONNECTED AND CREATED METALLIC DEBRIS, AND/OR LOOSENED FROM ACETABULUM, CAUSED SEVERE PAIN AND INHIBITED ABILITY TO WALK AFTER ASR HIP IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    148297 ASR UNI FEMORAL IMPL SIZE 46 TOTAL HIP REPLACEMENT KWA DEPUY INTERNATIONAL 2380006

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R