BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSAFITCUP DM LINER O 28/56

    MDR report key: 4747282 · Received April 30, 2015

    Report

    Report Number
    3005180920-2015-00078
    Event Type
    Injury
    Date Received
    April 30, 2015
    Report Date
    July 28, 2015
    Manufacturer
    MEDACTA INTERNATIONAL, SA
    Product Code
    MEH
    PMA / PMN Number
    K092265
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON 06/30/2015 IT WAS PREPARED A FINAL REPORT WITH THE INFORMATION COLLECTED DURING THE INVESTIGATION, ALREADY REPORTED IN THE INITIAL REPORT. ON 07/09/2015 THE REPORT WAS SENT TO THE INITIAL REPORTER AND THE CASE WAS CLOSED.

    Additional Manufacturer Narrative · 1

    THIS REVISION IS LINKED TO MDRS 2014-00091 AND 2015-00031. BATCH REVIEW PERFORMED ON 04/30/2015: LOT 146555: (B)(4) LINERS PRODUCED AND RELEASED ON 11/26/2014. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR ISSUE. CODE 01.12.22SN (K082792) LOT 090113: (B)(4) STEMS PRODUCED AND RELEASED ON 02/25/2009. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR ISSUE. THIS COMPONENT WAS IMPLANTED DURING THE PRIMARY SURGERY ON (B)(6) 2009. CODE 01.25.011 (K072857) LOT 141037: (B)(4) HEADS PRODUCED AND RELEASED ON 06/17/2014. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR ISSUE. THIS COMPONENT WAS IMPLANTED DURING THE 3RD REVISION ON (B)(6) 2015. CODE 01/26/54MB (K083116) LOT 144749: (B)(4) CUPS PRODUCED AND RELEASED ON 10/13/2014. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR ISSUE. THIS COMPONENT WAS IMPLANTED DURING 2ND REVISION ON 11/12/2014. THE PATHOGEN FOUND WAS ENTEROCOCCUS FAECALIS.

    Description of Event or Problem · 1

    (B)(4).

    Description of Event or Problem · 1

    REFERENCE (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    286407 VERSAFITCUP DM LINER O 28/56 PE DOUBLE MOBILITY LINER MEH MEDACTA INTERNATIONAL, SA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK