BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOTAL ASR ACET IMP SIZE 54

    MDR report key: 3243800 · Received July 23, 2013

    Report

    Report Number
    1818910-2013-21951
    Event Type
    Injury
    Date Received
    July 23, 2013
    Date of Event
    April 16, 2012
    Report Date
    April 25, 2014
    Manufacturer
    DEPUY INTERNATIONAL LTD.
    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

    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

    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

    REASON FOR REVISION - ALVAL / SOFT TISSUE.

    Description of Event or Problem · 1

    ASR REVISION. ASR XL - LEFT. REASON FOR REVISION - ALVAL / SOFT TISSUE. UPDATE - ADDED REFERENCE NUMBER, HOSPITAL, AMENDED SURGEON TO CORRECT NAME, ADDED A STEM. TAKEN FROM (B)(6) DATED 23RD JULY 2013. UPDATE RECEIVED: 25TH APRIL 2014 - FILLED MAPPED TO MW FIELDS, MARKED AS LEGAL, ADDED HOSPITAL: (B)(6) HOSPITAL (B)(6) AND ADDED (B)(6) REFERENCE NUMBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342379 TOTAL ASR ACET IMP SIZE 54 HIP ACETABULAR CUP KWA DEPUY INTERNATIONAL LTD. 2585559

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention