BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSAFITCUP CC FLAT PE HC LINER Ø 36/G

    MDR report key: 5647013 · Received May 11, 2016

    Report

    Report Number
    3005180920-2016-00213
    Event Type
    Injury
    Date Received
    May 11, 2016
    Date of Event
    April 10, 2016
    Report Date
    July 26, 2016
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    PMA / PMN Number
    K103352
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON 08 JULY 2016 IT WAS PREPARED A FINAL REPORT WITH THE INFORMATION ALREADY SUBMITTED IN THE INITIAL REPORT. ON 18 JULY 2016 THE REPORT WAS SENT TO THE INITIAL REPORTER AND THE CASE WAS CLOSED.

    Additional Manufacturer Narrative · 1

    ON 29 APRIL 2016 THE MEDICAL AFFAIRS PERFORMED A CLINICAL EVALUATION AND COMMENTED AS FOLLOWS: RECURRING EARLY DISLOCATION IN A CEMENTLESS PRIMARY THA PERFORMED TWO MONTHS BEFORE. LATERALIZATION AND LENGTHENING HAS BEEN ACHIEVED THROUGH A MODIFIED HEAD AND SUBSTITUTION OF INLAY WITH A HOODED VERSION. THE COMPONENTS LOOK APPROPRIATELY POSITIONED, PROBABLY THE CAUSE FOR THE RECURRING DISLOCATION WAS INSUFFICIENT SOFT TISSUE TENSION OR SLIGHT IMMEDIATE SUBSIDENCE. NO REASON TO SUSPECT THAT A MALFUNCTIONING DEVICE CAUSED THE PROBLEM. BATCH REVIEW PERFORMED ON 09 MAY 2016. LOT 134964: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12 DECEMBER 2013. EXPIRATION DATE: 2018-10-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. MECTACER DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE L + 4, CODE 01.29.210, LOT. 152618 (K112115) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26 OCTOBER 2015. EXPIRATION DATE: 2020-10-10. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. VERSAFITCUP CC TRIO ACETABULAR SHELL Ø 62, CODE 01.26.45.0062, LOT. 144699 (K103352) [NOT EXPLANTED] (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10 OCTOBER 2014. EXPIRATION DATE: 2019-08-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. NOT AVAILABLE.

    Description of Event or Problem · 1

    THE PATIENT HAD 2 DISLOCATIONS AFTER THE PRIMARY SURGERY, SO THE SURGEON DECIDED TO REVISE HEAD AND LINER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302891 VERSAFITCUP CC FLAT PE HC LINER Ø 36/G FLAT PE LINER LZO MEDACTA INTERNATIONAL SA 134964

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention