BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNIDENTIFIED ASR CUP

    MDR report key: 3852327 · Received June 5, 2014

    Report

    Report Number
    1818910-2014-20330
    Event Type
    Death
    Date Received
    June 5, 2014
    Report Date
    May 21, 2014
    Manufacturer
    DEPUY INTERNATIONAL LTD. 8010379
    Product Code
    KWA
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PATIENT

    Narratives

    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. THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED. DEVICE CONTRIBUTION CANNOT BE EXCLUDED AS A CONTRIBUTING FACTOR IN PATIENT'S DEATH.

    Description of Event or Problem · 1

    DECEASED PATIENT (BELOW IS ALL THE INFO WE HAVE AT THIS TIME). WHEN WERE THEY FIRST OPERATED ? RESPONSE: (B)(6). DID THEY UNDERGO REVISION SURGERY? RESPONSE: NO. WHAT IS THERE MEDIAL HISTORY, AGE PERSONAL PROFILE ETC. RESPONSE: AGE IS (B)(6), MEDICAL HISTORY; INABILITY TO WALK, COMPLAINS OF SEVERE PAIN (THIS INFORMATION WE HAVE RECEIVED DURING THE TIME OF REGISTRATION). WHAT WAS THE CAUSE OF DEATH? RESPONSE: PAIN DUE TO IMPLANT (THROUGH VERBALLY). HOW AND WHEN DID WE GET TO KNOW ABOUT THEIR DEATH. RESPONSE: THROUGH PATIENT¿S SON ON (B)(6) 2014 OVER PHONE. WHAT IS THE MEDICAL REASON RECORDED FOR THEIR DEATH. RESPONSE: NOT AVAILABLE. ANY OTHER RELEVANT DETAILS / FACTS. RESPONSE: NOT AVAILABLE. KINDLY NOTE THAT THIS PATIENT DOESN¿T PROVIDE PCF AND PRIMARY SURGERY PRODUCT DETAILS TO US TILL DATE, HENCE WE DON¿T HAVE PCF FROM THE PATIENT AND THE CASE HAS NOT BEEN VALIDATED TILL DATE AND WE DON¿T HAVE ANY OTHER ADDITIONAL INFORMATION PERTAINING TO THIS CASE. AS A FOLLOW-UP CALL, TODAY WE TRIED TO REACH THE PATIENT FOR PCF, THE PATIENT¿S SON ATTEND THE CALL AND HE HOLD THAT HER MOTHER WAS EXPIRED TWO MONTHS AGO AND HE IS NOT READY TO PROVIDE ANY ADDITIONAL DETAILS ABOUT HER MOTHER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328771 UNIDENTIFIED ASR CUP HIP ACETABULAR CUP KWA DEPUY INTERNATIONAL LTD. 8010379

    Patients

    Seq Age Sex Outcome Treatment
    1 Death