BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOTAL ASR ACET IMP SIZE 52

    MDR report key: 4146271 · Received October 7, 2014

    Report

    Report Number
    1818910-2014-29499
    Event Type
    Injury
    Date Received
    October 7, 2014
    Date of Event
    September 2, 2014
    Report Date
    April 24, 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
    AS
    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. (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 : ALVAL / SOFT TISSUE REACTION. DOR AND HOSPITAL - UNKNOWN. QUERY EMAIL SENT WITH REGARDS DOI AS THE SLEEVE WAS MADE AFTER THE ORIGINAL SURGERY DATE QUOTED. RESPONSE RECEIVED QUOTING (B)(6) 2011 HOWEVER AS THIS IS AFTER THE RECALL DATE THIS CAN NOT BE CORRECT EITHER. THEREFORE HAVE QUERIED AGAIN. UPDATE - (B)(6) 2014 - DOR CONFIRMED AS (B)(6) 2014. CONFIRMATION RECEIVED DOI - (B)(6) 2006. UPDATE - ADDED HOSPITAL, ADDED A STEM, ADDED LOT NUMBER FOR HEAD, ADDED ALL EXPIRY DATES. TAKEN FROM CLAIMSUITE DATED (B)(6) 2015. HOSPITAL: (B)(6), HEAD LOT NUMBER - 1964507.

    Description of Event or Problem · 1

    ASR REVISION, ASR XL, RIGHT, REASON(S) FOR REVISION : ALVAL / SOFT TISSUE REACTION, DOR AND HOSPITAL - UNKNOWN. QUERY EMAIL SENT WITH REGARDS DOI AS THE SLEEVE WAS MADE AFTER THE ORIGINAL SURGERY DATE QUOTED. RESPONSE RECEIVED QUOTING (B)(4) 2011, HOWEVER, AS THIS IS AFTER THE RECALL DATE THIS CAN NOT BE CORRECT EITHER. THEREFORE HAVE QUERIED AGAIN. UPDATE (B)(4) 2014 - DOR CONFIRMED AS (B)(6) 2014. CONFIRMATION RECEIVED DOI - (B)(6) 2006.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    628845 TOTAL ASR ACET IMP SIZE 52 HIP ACETABULAR CUP KWA DEPUY INTERNATIONAL LTD. 8010379 1870303

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention