BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOTAL ASR FEM IMP SIZE 46

    MDR report key: 2875302 · Received December 17, 2012

    Report

    Report Number
    1818910-2012-25864
    Event Type
    Injury
    Date Received
    December 17, 2012
    Date of Event
    October 25, 2012
    Report Date
    July 23, 2014
    Manufacturer
    DEPUY INTERNATIONAL LTD.
    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. DEPUY STILL CONSIDERS THIS CASE CLOSED TO CAPA.

    Additional Manufacturer Narrative · 1

    DEPUY STILL CONSIDERS THE INVESTIGATION CLOSED.

    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.

    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.

    Description of Event or Problem · 1

    ADDITIONAL REASON FOR REVISION: CLICKING.

    Description of Event or Problem · 1

    NEW (B)(6) RECORD CREATED IN ORDER TO UPDATE (B)(6) (LEGACY SYSTEM) COMPLAINT NUMBER (B)(4). REASON FOR ORIGINAL COMPLAINT - ASR REVISION. HIP(S) TO BE REVISED: LEFT. ASR HIP RESURFACING SYSTEM. REASON(S) FOR REVISION: PAIN. UPDATE - ADDED ADDITIONAL REASON FOR REVISION AND PATIENT ID, TAKEN FROM (B)(6) DATED 27TH MARCH 2013. REASON FOR REVISION: CLICKING. UPDATE - AMENDED ORIGINAL SURGERY DATE TAKEN FROM (B)(6) DATED 3RD JAN 2014. UPDATE - AMENDED SURGERY DATE, REVISION DATE, CORRECT ORIGINAL HOSPITAL AND ADDED ADDITIONAL HOSPITAL, FILLED OUT MW FIELDS, MARKED AS LEGAL ADDED (B)(6) NUMBER TAKEN FROM (B)(6) DATED 23RD JULY 2014.

    Description of Event or Problem · 1

    ASR REVISION; ASR HIP RESURFACING SYSTEM - LEFT HIP; REASON FOR REVISION: PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TOTAL ASR FEM IMP SIZE 46 HIP FEMORAL HEAD KXA DEPUY INTERNATIONAL LTD. 1852068

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention