BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOTAL ASR FEM IMP SIZE 45

    MDR report key: 3241592 · Received July 22, 2013

    Report

    Report Number
    1818910-2013-21836
    Event Type
    Injury
    Date Received
    July 22, 2013
    Date of Event
    April 17, 2013
    Report Date
    July 11, 2014
    Manufacturer
    DEPUY INTERNATIONAL LTD.
    Product Code
    KXA
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    NO 510(K) NUMBER PROVIDED BECAUSE THIS IMPLANT IS SOLD INTERNATIONALLY WITH DIFFERENT INDICATIONS FOR USE; IT IS CURRENTLY SOLD IN THE US UNDER A DIFFERENT PART NUMBER. THE CORRECTION/REMOVAL REPORTING NUMBER LISTED APPLIES TO THE CORRESPONDING PRODUCT CODE SOLD DOMESTICALLY. 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.

    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.

    Description of Event or Problem · 1

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

    Description of Event or Problem · 1

    ASR REVISION. ASR RESURFACING- LEFT. REASON(S) FOR REVISION: UNKNOWN. UPDATE - FILED OUT MW FIELDS, ADDED FILE HANDLER DETAILS, ADDED CORRECT LOT NUMBER TO CUP, ADDED REASON FOR REVISION, SURGEONS X 2, ADDITIONAL HOSPITAL AND AMENDED SURGERY DATE. ATTACHED SURGEON FORM. TAKEN FROM SURGEON FORM DATED (B)(6) 2014 AND CLAIMSUITE DATED 12TH JULY 2014. REASON(S) FOR REVISION: PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341045 TOTAL ASR FEM IMP SIZE 45 HIP FEMORAL HEAD KXA DEPUY INTERNATIONAL LTD. 1190894

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention ASR ACETABULAR IMPLANT 50.