BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSAFITCUP CC TRIO ACETABULAR SHELL

    MDR report key: 6763321 · Received August 3, 2017

    Report

    Report Number
    3005180920-2017-00439
    Event Type
    Injury
    Date Received
    August 3, 2017
    Date of Event
    July 10, 2017
    Report Date
    August 3, 2017
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030807794
    PMA / PMN Number
    K103352
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 31 JULY 2017: LOT 155366: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18 JANUARY 2016. EXPIRATION DATE: 2021-01-05. NO ANOMALIES FOUND RELATED TO THE REPORTED ISSUE. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. CANCELLOUS BONE SCREW FLAT HEAD Ø 6,5 L 25 CODE 01.26.65.25 LOT. 154186 (K103352): (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06 OCTOBER 2015. EXPIRATION DATE: 2020-08-31. NO ANOMALIES FOUND RELATED TO THE REPORTED ISSUE. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. CANCELLOUS BONE SCREW FLAT HEAD Ø 6,5 L 30 CODE 01.26.65.30 LOT. 153635 (K103352): (B)(4) ITEMS MANUFACTURED AND RELEASED ON 09 SEPTEMBER 2015. EXPIRATION DATE: 2020-06-30. NO ANOMALIES FOUND RELATED TO THE REPORTED ISSUE. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITH 1 SIMILAR REPORTED EVENT. VERSAFITCUP CC TRIO FLAT PE HC LINER Ø 36/F CODE 01.26.3648HCT LOT. 142649 (K103352): (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26 JULY 2014. EXPIRATION DATE: 2019-05-31. NO ANOMALIES FOUND RELATED TO THE REPORTED ISSUE. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE S CODE 01.29.208 LOT. 155936 (K112115): (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20 JANUARY 2016. EXPIRATION DATE: 2021-01-06. NO ANOMALIES FOUND RELATED TO THE REPORTED ISSUE. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. AMISTEM H COLLARED HA COATED STD STEM #4 CODE 01.18.234 LOT. 155248 (K121011): (B)(4) ITEMS MANUFACTURED AND RELEASED ON 15 JANUARY 2016. EXPIRATION DATE: 2021-01-02. NO ANOMALIES FOUND RELATED TO THE REPORTED 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

    THE PATIENT CAME IN DUE TO SIGNS OF INFECTION. THE PATHOGEN IS UNKNOWN. THE SURGEON REMOVED ALL MEDACTA HARDWARE AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY. X-RAYS AND EXPLANTS ARE NOT AVAILABLE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    546310 VERSAFITCUP CC TRIO ACETABULAR SHELL CEMENTLESS ACETABULAR SHELL Ø 56 LZO MEDACTA INTERNATIONAL SA 155366 07630030807794

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention