BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORAIL2 NON COL HO SIZE 14

    MDR report key: 4770504 · Received May 13, 2015

    Report

    Report Number
    1818910-2015-20699
    Event Type
    Injury
    Date Received
    May 13, 2015
    Date of Event
    August 27, 2013
    Report Date
    May 14, 2015
    Manufacturer
    DEPUY FRANCE SAS-3003895575
    Product Code
    KWA
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEPUY STILL CONSIDERS THE INVESTIGATION CLOSED.

    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. (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. (B)(4).  DEPUY SYNTHES HAS BEEN INFORMED THAT THE LOT NUMBER IS NOT AVAILABLE.

    Description of Event or Problem · 1

    ASR REVISION; ASR XL- LEFT; REASON(S) FOR REVISION: UNKNOWN. UPDATE RECEIVED: 22ND JULY 2013 - ADDED LOT NUMBER TO CUP: 1877479. UPDATE RECEIVED: AMENDED SIDE HIP: RIGHT. UPDATE - ADDED HOSPITAL AND REVISION DATE TAKEN FROM CLAIMSUITE DATED (B)(6) 2013. 28 APRIL 2015 - UPDATE - RCVD UPDATE CLAIMSUITE AND OP NOTES, ADDED PATIENT NAME, DOB, GENDER, ADDED STEM DETAILS AND MANU AND EXP DATES OF PRODUCTS, ADDED REASON FOR REVISION: COBALT/CHROMIUM LEVELS ARE HIGH, LOOSENING OF ACETABULAR AND FEMORAL COMPONENT, PSEUDO TUMOUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313294 CORAIL2 NON COL HO SIZE 14 HIP FEMORAL STEM/SLEEVE KWA DEPUY FRANCE SAS-3003895575 1991913

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention