BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOTAL ASR FEM IMP SIZE 51

    MDR report key: 3954205 · Received July 23, 2014

    Report

    Report Number
    1818910-2014-24120
    Event Type
    Injury
    Date Received
    July 23, 2014
    Date of Event
    August 30, 2012
    Report Date
    November 24, 2015
    Manufacturer
    DEPUY INTERNATIONAL LTD. 8010379
    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. 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. REF. (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

    ADDITIONAL INFORMATION RECEIVED INDICATING THAT THE DEVICE IS NOT CONTRIBUTING TO THE ISSUE; THEREFORE; THIS REPORT IS BEING REJECTED.

    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

    NEW ETQ RECORD CREATED IN ORDER TO UPDATE ETQ (LEGACY SYSTEM) COMPLAINT NUMBER (B)(4). REASON FOR ORIGINAL COMPLAINT ¿ ASR REVISION, TYPE OF PRODUCT: UNKNOWN, SIDE HIP TO BE REVISED: LEFT. REASON(S) FOR REVISION: NIGHT PAIN, RESTRICTED RANGE OF MOTION, FUNCTION IMPAIRED AND THE HIP WAS DRY AND THE SURROUNDING TISSUE MACROSCOPICALLY NORMAL. UPDATE RECEIVED: (B)(6) 2013 - ADDED PATIENT REFERENCE NUMBER: (B)(4), PATIENT NAME: (B)(6), ADDED PRODUCT TYPE: ASR RESURFACING SYSTEM AND REASON FOR REVISION: PAIN. UPDATE (B)(6) ALERT RECEIVED. ADDED HEAD PRODUCT AND CORRECTED HOSPITAL.

    Description of Event or Problem · 1

    UPDATE - TWO FILES WERE DUPLICATED WITH CRAWFORDS - HAVE NOW CHANGED THE 47 REFERENCE NUMBER FROM (B)(4). (B)(4) IS AN INVALID REF NUMBER. SEE EMAIL DATED 1ST DEC 2015. FILLED OUT ALL MW FIELDS, MANUFACTURING AND EXPIRY DATES. ADDED ADDITIONAL REASON FOR REVISION TAKEN FROM SCF DATED 24TH NOV 2015. REASON(S) FOR REVISION: COMPONENT LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    430058 TOTAL ASR FEM IMP SIZE 51 HIP FEMORAL HEAD KXA DEPUY INTERNATIONAL LTD. 8010379 2346275

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention