BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORAIL2 STD SIZE 12

    MDR report key: 4754021 · Received May 6, 2015

    Report

    Report Number
    1818910-2015-20175
    Event Type
    Injury
    Date Received
    May 6, 2015
    Date of Event
    May 16, 2006
    Report Date
    May 7, 2015
    Manufacturer
    DEPUY FRANCE SAS-3003895575
    Product Code
    KWA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    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).

    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 - LEFT HIP. TYPE OF HIP REPLACEMENT PRODUCT: ASR XL ACETABULAR SYSTEM (LEFT). UPDATE: ADDED ITEM NUMBERS AND HOSPITAL NAME AMENDED DATE OF REVISION. RECEIVED: (B)(6) 2013. REASON(S) FOR REVISION: UNKNOWN. UPDATE- ADDED LOT NUMBERS FOR CUP, HEAD AND SLEEVE TAKEN FROM CLAIMSUITE DATED (B)(6) 2013 UPDATE - RECEIVED 4 MARCH 2013 - REASON FOR REVISION. REASON FOR REVISION: COMPONENT LOOSENING. UPDATE - ADDED STEM, QUERYING LOT NUMBER FOR SLEEVE AND COMPONENT LOOSENING. TAKEN FROM CLAIMSUITE DATED (B)(6) 2015. UPDATE - ADDED LOT NUMBER MANUFACTURING AND EXPIRY DATE FOR SLEEVE. STEM BECAME LOOSE. CONFIRMATION THAT THIS IS THE FIRST OF 2 SURGERIES. THE CUP AND HEAD REMAINED IN SITU BUT BOTH THE STEM AND SLEEVE WERE REVISED AND REPLACED. FOR THE SECOND SURGERY PLEASE SEE COM 114176. INFO TAKEN FROM STEM LOOSENING EMAIL DATED (B)(6) 2015 AND PRODUCTS EMAIL DATED (B)(6) 2015. (B)(6). LOT NUMBER FOR SLEEVE - 1811611.

    Description of Event or Problem · 1

    UPDATE - ATTACHED OPERATIVE NOTES AND PRODUCT STICKERS, ADDED PATIENT GENDER AND DATE OF BIRTH. TAKEN FROM EMAIL DATED 7TH MAY 2015.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    296416 CORAIL2 STD SIZE 12 HIP FEMORAL STEM/SLEEVE KWA DEPUY FRANCE SAS-3003895575 1873798

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention