BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORAIL2 NON COL HO SIZE 9

    MDR report key: 1940235 · Received December 23, 2010

    Report

    Report Number
    1818910-2010-09492
    Event Type
    Malfunction
    Date Received
    December 23, 2010
    Date of Event
    November 25, 2010
    Report Date
    October 7, 2015
    Manufacturer
    DEPUY FRANCE SAS - 30038955755
    Product Code
    KWA
    PMA / PMN Number
    K042992
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    DEPUY STILL 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

    CORRECTED: DESCRIBE EVENT OR PROBLEM, BRAND NAME, COMMON DEVICE NAME/DEVICE PRODUCT CODE, MANUFACTURER NAME/ADDRESS, IF EXPLANTED, CONTACT OFFICE NAME/ADDRESS, PMA/510(K) NUMBER. THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    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. WWCAPA (B)(4).

    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

    RECOMMENDED ASR REVISION - RIGHT HIP.

    Description of Event or Problem · 1

    REASON FOR REVISION IS UNKNOWN.

    Description of Event or Problem · 1

    REASON(S) FOR REVISION: ALVAL / SOFT TISSUE REACTION.

    Description of Event or Problem · 1

    UPDATE - UPDATED IMPLANT DATE. TAKEN FROM CLAIMSUITE DATED 7TH OCTOBER 2015.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CORAIL2 NON COL HO SIZE 9 HIP FEMORAL STEM/SLEEVE KWA DEPUY FRANCE SAS - 30038955755 NA 2291913

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention