BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASR ACETABULAR IMPLANT 56

    MDR report key: 2023403 · Received March 2, 2011

    Report

    Report Number
    1818910-2011-02756
    Event Type
    Malfunction
    Date Received
    March 2, 2011
    Report Date
    November 20, 2015
    Manufacturer
    DEPUY INTERNATIONAL LTD - 8010379
    Product Code
    KWA
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    UNKNOWN

    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 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

    (B)(4). 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

    (B)(4).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

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. DEPUY STILL CONSIDERS THIS CASE CLOSED TO CAPA.

    Description of Event or Problem · 1

    ASR REVISION RECOMMENDED. ASR HIP RESURFACING SYSTEM (LEFT). PATIENT SYMPTOMS: PAIN, UNABLE TO SIT OR WALK.

    Description of Event or Problem · 1

    UPDATE 20 NOVEMBER 2015: ADDED ADDITIONAL HOSPITAL, ADDED DOR, UPDATED FILE HANDLER DETAILS. ADDED LOT NUMBERS, MANUFACTURE AND EXPIRY DATES TO PRODUCTS. UPDATE 25 NOV. 2015: UPDATED PATIENT AS BILATERAL. REMOVED LOT NUMBERS, MANUFACTURE AND EXPIRY DATES AS THOSE PROVIDED ON THE ASR CONFIRMATION LETTER WERE ACTUALLY FOR THE RIGHT HIP.

    Description of Event or Problem · 1

    THE PATIENT HAS BEEN RECOMMENDED FOR AN ASR REVISION. SPECIFIC DETAILS REGARDING THE REPORT ARE UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR ACETABULAR IMPLANT 56 ASR TOTAL HIP REPLACEMENT KWA DEPUY INTERNATIONAL LTD - 8010379 NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention