BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOTAL ASR FEM IMP SIZE 47

    MDR report key: 6141618 · Received December 2, 2016

    Report

    Report Number
    1818910-2016-32734
    Event Type
    Injury
    Date Received
    December 2, 2016
    Date of Event
    October 27, 2016
    Report Date
    November 10, 2016
    Manufacturer
    DEPUY INTERNATIONAL LTD. 8010379
    Product Code
    JDG
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    PATIENT

    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.

    Description of Event or Problem · 1

    PATIENT UNDERWENT A REVISION TO ADDRESS ALVAL/SOFT TISSUE REACTION, PAIN, CUP LOOSENING AND NOISE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    791230 TOTAL ASR FEM IMP SIZE 47 HIP FEMORAL HEAD JDG DEPUY INTERNATIONAL LTD. 8010379 2062267

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention