BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORAIL2 STD SIZE 11

    MDR report key: 6344098 · Received February 20, 2017

    Report

    Report Number
    1818910-2017-13011
    Event Type
    Injury
    Date Received
    February 20, 2017
    Date of Event
    January 13, 2017
    Report Date
    January 29, 2017
    Manufacturer
    DEPUY FRANCE SAS 3003895575
    Product Code
    KWA
    PMA / PMN Number
    K042992
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    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. 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. (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    ASR REVISION DUE (B)(6) 2017, ASR XL, LEFT. REASON(S) FOR REVISION: PAIN, NOISE UPDATE - ALERT DATE (B)(6) 2017. CRAWFORDS CONFIRMED REVISION SURGERY TOOK PLACE ON (B)(6) 2017. AMENDED EVENT DATE AND ADDED DATE OF REVISION - SEE ATTACHMENT DATED (B)(6) 2017. EK (B)(6) 2017. UPDATE ALERT DATE (B)(6) 2017. ADDED LOT NUMBER, MANUFACTURING DATE AND FACILITY FOR CUP AND HEAD - LOT NUMBERS UNAVAILABLE FOR STEM AND SLEEVE UPDATE AUG 15, 2017: EMAIL NOTIFICATION FROM KENNEDYS RECEIVED. THERE IS NO NEW INFORMATION ADDED. THIS COMPLAINT WAS UPDATED ON: AUG 18, 2017. THE REPORTED EVENT HAS BEEN EVALUATED AND WILL BE MONITORED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    REASON(S) FOR REVISION: PAIN, NOISE. UPDATE - ALERT DATE (B)(6) 2017 - (B)(6) CONFIRMED REVISION SURGERY TOOK PLACE ON (B)(6) 2017.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126078 CORAIL2 STD SIZE 11 HIP FEMORAL STEM/SLEEVE KWA DEPUY FRANCE SAS 3003895575 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention