BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEPUY ASR XL FEM IMP SIZE 51

    MDR report key: 2183518 · Received June 22, 2011

    Report

    Report Number
    1818910-2011-10820
    Event Type
    Malfunction
    Date Received
    June 22, 2011
    Date of Event
    June 15, 2011
    Report Date
    October 30, 2015
    Manufacturer
    DEPUY INTERNATIONAL LTD - 8010379
    Product Code
    KWA
    PMA / PMN Number
    K042992
    Removal / Correction Number
    Z1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UP
    Reporter Occupation
    UNKNOWN

    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).DEPUY 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.

    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

    REVISION DUE TO PAIN AND DISLOCATION, SECONDARY TO LOOSENING.

    Description of Event or Problem · 1

    UPDATED (B)(4) 2012 DATE OF PRIMARY SURGERY.

    Description of Event or Problem · 1

    UPDATE 5 NOV. 2015: UPDATED DOR, SURGEON DETAILS. FOR LEFT HIP UPDATE DETAILS (B)(4). ADDED MANUFACTURE AND EXPIRY DATES FOR PRODUCTS. QUERIED COMPONENT LOOSENING. TAKEN FROM CLAIMSUITE UPDATE 30 OCT. 2015. (PD 5 NOV. 2015). UPDATE 10 NOV. 2015: UPDATED THE CUP AS THE LOOSENING COMPONENT. TAKEN FROM REPLY TO 2ND REQUEST FOR INFORMATION.

    Description of Event or Problem · 1

    THE PT IS SCHEDULED FOR AN ASR REVISION TO ADDRESS PAIN AND DISLOCATION SECONDARY TO LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEPUY ASR XL FEM IMP SIZE 51 HIP FEMORAL HEAD KWA DEPUY INTERNATIONAL LTD - 8010379 NA 2684779

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention