BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO Ø 54

    MDR report key: 8217186 · Received January 4, 2019

    Report

    Report Number
    3005180920-2018-01055
    Event Type
    Injury
    Date Received
    January 4, 2019
    Date of Event
    December 5, 2018
    Report Date
    February 7, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030807787
    PMA / PMN Number
    K103352
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATE 9 JAN FROM THE SALES REPRESENTATIVE: THE REVISION SURGERY WAS SUCCESSFULLY COMPLETED TODAY AND THE SURGEON REMOVED ALL THE IMPLANTS DUE TO PAIN. THE SURGEON ADVISED THAT THERE WAS SLIGHT LOOSENING OF THE IMPLANTS WHICH HE FELT WAS THE CAUSE OF THE PAIN. X-RAYS AND EXPLANTS ARE NOT AVAILABLE.

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 03 JANUARY 2019: LOT 146986: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 02 DECEMBER 2014. EXPIRATION DATE: 2019-10-31. NO ANOMALIES FOUND RELATED TO THE ISSUE. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. OTHER DEVICES INVOLVED: LINER: CC E CC LIGHT FLAT PE HC LINER Ø 36 / E REFERENCE 01.26.3644HCT (K120531). LOT 148362: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 27 APRIL 2015. EXPIRATION DATE: 2020-03-31. NO ANOMALIES FOUND RELATED TO THE ISSUE. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITH 1 SIMILAR REPORTED EVENT. MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE M 0 REFERENCE 01.29.209 (K112115). LOT 150458: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13 MAY 2015. EXPIRATION DATE: 2020-03-31. NO ANOMALIES FOUND RELATED TO THE ISSUE. TO DATE, ALL THE ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITH 1 SIMILAR REPORTED EVENT. CANCELLOUS BONE SCREW FLAT HEAD Ø 6,5 L 30 REFERENCE 01.26.65.30 (K103352). LOT 147785: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03 MARCH 2015. EXPIRATION DATE: 2020-01-31. NO ANOMALIES FOUND RELATED TO THE ISSUE. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. K103352. CANCELLOUS BONE SCREW FLAT HEAD Ø 6,5 L 20 REFERENCE 01.26.65.20 (K103352). LOT 122778: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 02 AUGUST 2012. EXPIRATION DATE: 2017-08-31. NO ANOMALIES FOUND RELATED TO THE ISSUE. TO DATE, ALL THE ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. QUADRA-H 01.12.022 CEMENTLESS, HA COATED STD STEM SIZE 2 (K082792). LOT 147635: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 17 FEBRUARY 2015. EXPIRATION DATE: 2020-01-31. NO ANOMALIES FOUND RELATED TO THE ISSUE. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    REVISION SURGERY PLANNED FOR (B)(6) 2019 DUE TO PAIN, 3 YEARS AND A HALF AFTER THE PRIMARY SURGERY. THE SURGEON IS PLANNING TO REMOVE THE VERSAFIT CUP, LINER AND SCREWS AND WILL REVISE THE STEM IF REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12209 VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO Ø 54 ACETABULAR SHELL LZO MEDACTA INTERNATIONAL SA 146986 07630030807787

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention