BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOTAL ASR ACET IMP SIZE 62

    MDR report key: 3203360 · Received July 2, 2013

    Report

    Report Number
    1818910-2013-20441
    Event Type
    Injury
    Date Received
    July 2, 2013
    Date of Event
    February 6, 2014
    Report Date
    December 12, 2014
    Manufacturer
    DEPUY INTERNATIONAL LTD.
    Product Code
    KWA
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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. (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 HIP RESURFACING - LEFT;REASON(S) FOR REVISION: UNKNOWN KID 4743.

    Description of Event or Problem · 1

    ASR REVISION. ASR HIP RESURFACING - LEFT. REASON(S) FOR REVISION: UNKNOWN. UPDATE 12 DEC 2014 - UPDATED CLAIMSUITE AND SCF RECEIVED. ADDED LOOSENING (CUP) AND PAIN AS REASONS FOR REVISION. ADDED SURGEON NAME (DR. (B)(6)) AND (B)(6). UPDATED DOI AND DOR FROM SCF. UPDATED EACH PRODUCT WITH COMMON AND BRAND NAMES, MANUFACTURING AND EXPIRY DATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302427 TOTAL ASR ACET IMP SIZE 62 HIP ACETABULAR CUP KWA DEPUY INTERNATIONAL LTD. 2062131

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention