BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOTAL ASR FEM IMP SIZE 46

    MDR report key: 7305750 · Received March 1, 2018

    Report

    Report Number
    1818910-2018-54324
    Event Type
    Injury
    Date Received
    March 1, 2018
    Date of Event
    November 28, 2013
    Report Date
    January 31, 2018
    Manufacturer
    DEPUY INTERNATIONAL LTD. 8010379
    Product Code
    KWA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    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. PRODUCT COMPLAINT # ==> PC-(B)(4) INVESTIGATION SUMMARY ==> 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. THE INVESTIGATION REGARDING THE ROOT CAUSE(S) AND/OR CORRECTIVE ACTIONS WAS CONDUCTED UNDER MDD CAPA-(B)(4). ONGOING POST MARKET SURVEILLANCE IS CONDUCTED PER OUR PROCEDURES FOR THIS PRODUCT.

    Description of Event or Problem · 1

    INITIAL PROCEDURE, (B)(6) 2006 : RIGHT TOTAL HIP ARTHROPLASTY OF THE RESURFACING TYPE IT WAS REPORTED BY LEGAL THAT THE PATIENT WAS REVISED ON (B)(6) 2013 DUE TO SUSPECTED METALLIC EROSION ON RIGHT HIP RESURFACING PROSTHESIS. PATIENT WAS ORIGINALLY IMPLANTED WITH SIZE 46 ASR FEMORAL COMPONENT AND SIZE 52 ASR ACETABULAR COMPONENT. POSTOP DIAGNOSIS INDICATED THAT THERE WAS A RIGHT HIP PSEUDOTUMOR AND METALLOSIS. REVISED WITH NON -DEPUY SYNTHES PRODUCT. DEVICES INVOLVED: 9998-04-652 TOTAL ACETABULAR IMPLANT SIZE 52, LOT 1870304. THE 9998-03-946 FEMORAL IMPLANT SIZE 46, LOT 2021704.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149216 TOTAL ASR FEM IMP SIZE 46 ASR HIP SYSTEM : HIP METAL FEMORAL HEADS KWA DEPUY INTERNATIONAL LTD. 8010379 2021704

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention