BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO Ø 50

    MDR report key: 7793266 · Received August 17, 2018

    Report

    Report Number
    3005180920-2018-00611
    Event Type
    Injury
    Date Received
    August 17, 2018
    Date of Event
    July 20, 2018
    Report Date
    August 17, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030807794
    PMA / PMN Number
    K103352
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 17 AUGUST 2018. LOT 176989: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 14 FEBRUARY 2018 EXPIRATION DATE: 2023-02-05. 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 REFERENCE 01.29.206 (K112115) BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 32 SIZE L +4: LOT 174709: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 11 OCTOBER 2017. EXPIRATION DATE: 2022-10-03 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. QUADRA-H REFERENCE 01.12.034 (K082792) CEMENTLESS, HA COATED LAT STEM SIZE 4: LOT 151877: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 11 SEPTEMBER 2015. EXPIRATION DATE: 2020-08-24 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. LINER: CC E CC LIGHT REFERENCE 01.26.3248HCAT (K103352) HOODED PE HC FIXED LINER Ø 32 / F : LOT 170960: (B)(4) ITEMS MANUFACTURED AND RELEASED ON EXPIRATION DATE:2022-05-04 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. REFERENCE 01.26.65.25 (K103352) CANCELLOUS BONE SCREW, FLAT HEAD Ø 6,5 L 25: LOT 176929:(B)(4) ITEMS MANUFACTURED AND RELEASED ON 23 NOVEMBER 2017. EXPIRATION DATE: 2022-10-23 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. LOT 179026: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 31 JANUARY 2018. EXPIRATION DATE:2023-01-15 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.

    Description of Event or Problem · 1

    REVISION SURGERY DUE TO INFECTION 2 MONTHS AFTER PRIMARY SURGERY. PATHOGEN NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    633411 VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO Ø 50 ACETABULAR SHELL LZO MEDACTA INTERNATIONAL SA 176989 07630030807794

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention