BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOTAL ASR ACET IMP SIZE 50

    MDR report key: 3677982 · Received March 13, 2014

    Report

    Report Number
    1818910-2014-14304
    Event Type
    Injury
    Date Received
    March 13, 2014
    Date of Event
    February 22, 2014
    Report Date
    March 20, 2014
    Manufacturer
    DEPUY INTERNATIONAL LTD. LS11 8DT
    Product Code
    KWA
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    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. 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.

    Additional Manufacturer Narrative · 1

    DEPUY STILL CONSIDERS THE INVESTIGATION CLOSED. 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

    ASR REVISION. ASR XL - RIGHT. REASON(S) FOR REVISION: PAIN.

    Description of Event or Problem · 1

    ASR REVISION. ASR XL - RIGHT. REASON(S) FOR REVISION: PAIN. UPDATE RECEIVED: 20TH MARCH 2014 - ADDED PATIENT ID (INITIALS), ADDED REFERENCE NUMBER, ADDED HOSPITAL AREA: (B)(6), ADDED FURTHER HOSPITAL: (B)(6), ADDED FURTHER REVISION REASON: LIMPING WHILE WALKING, ADDED PATIENT GENDER AND ADDED PATIENT AGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    150808 TOTAL ASR ACET IMP SIZE 50 HIP ACETABULAR CUP KWA DEPUY INTERNATIONAL LTD. LS11 8DT 2178037

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention