BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOTAL ASR FEM IMP SIZE 51

    MDR report key: 2902235 · Received January 8, 2013

    Report

    Report Number
    1818910-2013-00141
    Event Type
    Injury
    Date Received
    January 8, 2013
    Date of Event
    April 7, 2010
    Report Date
    March 28, 2014
    Manufacturer
    DEPUY INTERNATIONAL
    Product Code
    KXA
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    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).

    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. THE CORRECTION/REMOVAL REPORTING NUMBER LISTED APPLIES TO THE CORRESPONDING PRODUCT CODE SOLD DOMESTICALLY.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ASR REVISION; ASR HIP RESURFACING - RIGHT HIP; REASON FOR REVISION: DISLOCATIONS (NOT ARISING FROM TRAUMATIC EVENT).

    Description of Event or Problem · 1

    NEW ETQ RECORD CREATED IN ORDER TO UPDATE ETQ (LEGACY SYSTEM) (B)(4). REASON FOR ORIGINAL COMPLAINT: ASR REVISION, RIGHT, ASR HIP RESURFACING. REASON(S) FOR REVISION: DISLOCATIONS (NOT ARISING FROM TRAUMATIC EVENT). UPDATE RECEIVED 24TH MARCH 2014. REVISION DATE AMENDED. UPDATE RECEIVED: 28TH MARCH 2014 - ADDED HOSPITAL: (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9184 TOTAL ASR FEM IMP SIZE 51 HIP FEMORAL HEAD KXA DEPUY INTERNATIONAL 1158705

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention