BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOTAL ASR ACET IMP SIZE 52

    MDR report key: 3865034 · Received June 11, 2014

    Report

    Report Number
    1818910-2014-20660
    Event Type
    Injury
    Date Received
    June 11, 2014
    Date of Event
    August 28, 2013
    Report Date
    August 4, 2015
    Manufacturer
    DEPUY INTERNATIONAL LTD. 8010379
    Product Code
    KWA
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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. DEPUY STILL CONSIDERS THIS CASE CLOSED TO CAPA.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: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. (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

    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

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

    Description of Event or Problem · 1

    UPDATE 4 AUGUST 2015: THIS IS THE 2ND OF 2 REVISIONS. ORIGINAL IMPLANT DATE IS (B)(6) 2003. THE FIRST REVISION, RESURFACING TO XL, WAS ON (B)(6) 2005. THE SECOND REVISION WAS (B)(6) 2013. HAVING QUERIED DETAILS OF THE FIRST REVISION, THE ORIGINAL IMPLANTS WERE NOT ASR PRODUCTS. ADDED CRAWFORD REFERENCE NUMBER AND UPDATED REASON FOR REVISION TO INCLUDE PAIN AND ALVAL / SOFT TISSUE REACTION. ADDED SURGEON NAME, (B)(6), AND ADDED EXPIRY DATES FOR PRODUCTS. TAKEN FROM ORIGINAL CLAIMSUITE AND SCF.

    Description of Event or Problem · 1

    ASR REVISION.ASR XL - RIGHT. REASON(S) FOR REVISION: UNKNOWN.UPDATE - ADDED SURGEON X 2 AND HOSPITAL TAKEN FROM KENNEDYS EMAIL DATED 30TH JULY 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    345828 TOTAL ASR ACET IMP SIZE 52 HIP ACETABULAR CUP KWA DEPUY INTERNATIONAL LTD. 8010379 1827184

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention