BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOTAL ASR FEM IMP SIZE 51

    MDR report key: 2880165 · Received December 19, 2012

    Report

    Report Number
    1818910-2012-28670
    Event Type
    Injury
    Date Received
    December 19, 2012
    Date of Event
    August 22, 2011
    Report Date
    July 3, 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

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. MFR 1818910 - 2012 - 28670 WAS REPORTED IN ERROR AND IS BEING REJECTED.

    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

    DEPUY STILL 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

    ASR REVISION;ASR RESURFACING - LEFT;REASON(S) FOR REVISION: COMPONENT MALALIGNMENT.

    Description of Event or Problem · 1

    ADDITIONAL REASON(S) FOR REVISION: PAIN.

    Description of Event or Problem · 1

    NEW ETQ RECORD CREATED IN ORDER TO UPDATE ETQ (LEGACY SYSTEM) COMPLAINT NUMBER (B)(4). REASON FOR ORIGINAL COMPLAINT - ASR REVISION. ASR RESURFACING - LEFT. REASON(S) FOR REVISION: COMPONENT MALALIGNMENT. UPDATE - ADDED ADDITIONAL REASON FOR REVISION TAKEN FROM CLAIMSUITE DATED 27TH APRIL 2013. REASON(S) FOR REVISION: PAIN. UPDATE RECEIVED: 3RD JULY 2014 - RE-CREATED TO SEND TO VOID AS DUPLICATE OF (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TOTAL ASR FEM IMP SIZE 51 ASR TOTAL HIP REPLACEMENT KXA DEPUY INTERNATIONAL 2394260

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention