BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORAIL AMT COLLAR SIZE 12

    MDR report key: 5479834 · Received March 4, 2016

    Report

    Report Number
    1818910-2016-14648
    Event Type
    Injury
    Date Received
    March 4, 2016
    Date of Event
    August 21, 2013
    Report Date
    February 8, 2016
    Manufacturer
    DEPUY FRANCE S.A.S.-SAINT PRIEST ¿ REG# 3003895575
    Product Code
    KWA
    PMA / PMN Number
    PK042992
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THE INVESTIGATION ONCE IT HAS BEEN COMPLETED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. (B)(4).

    Additional Manufacturer Narrative · 1

    REPORT OF FORMAL CLAIM RECEIVED FROM KENNEDYS REGARDING PINNACLE MOM HIP IMPLANT REVISION DUE TO PAIN LATERALLY AND IN THE GROIN AREA. NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. A WORLDWIDE COMPLAINT DATABASE SEARCH IDENTIFIED NO PREVIOUS COMPLAINTS REFERENCING THE CUP PRODUCT LOT A3CFB1000, METAL INSERT LOT 2291368 AND HEAD LOT 2290676. A WORLDWIDE COMPLAINTS DATABASE SEARCH IDENTIFIED ONE PREVIOUS COMPLAINT REFERENCING THE COLLAR LOT 2203500 ((B)(4)). A REVIEW OF (B)(4) IDENTIFIED THAT NO PRODUCTS WERE RECEIVED FOR INVESTIGATION AND THE COMPLAINT WAS CLOSED IN 2014 WITH AN UNDETERMINED CONCLUSION. BASED ON PREVIOUS INVESTIGATIONS THIS COMPLICATION OF JOINT REPLACEMENT IS UNLIKELY TO HAVE BEEN THE RESULT OF A DEVICE FAILING TO MEET REQUIRED SPECIFICATIONS. THE INFORMATION RECEIVED WILL BE RETAINED FOR POTENTIAL SERIES INVESTIGATIONS IF TRIGGERED BY TREND ANALYSIS, POST MARKET SURVEILLANCE, OR OTHER EVENTS WITHIN THE QUALITY SYSTEM. CORRECTIVE ACTION WAS NOT INDICATED. DEPUY STILL 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.

    Description of Event or Problem · 1

    REPORT OF FORMAL CLAIM RECEIVED FROM KENNEDYS REGARDING PINNACLE MOM HIP IMPLANT REVISION DUE TO PAIN LATERALLY AND IN THE GROIN AREA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136262 CORAIL AMT COLLAR SIZE 12 HIP FEMORAL STEM/SLEEVE KWA DEPUY FRANCE S.A.S.-SAINT PRIEST ¿ REG# 3003895575 2203500

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention