BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINER: VERSAFITCUP CC TRIO FLAT PE HC LINER 32 / E

    MDR report key: 10482178 · Received September 2, 2020

    Report

    Report Number
    3005180920-2020-00575
    Event Type
    Injury
    Date Received
    September 2, 2020
    Date of Event
    August 18, 2020
    Report Date
    September 2, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030807572
    PMA / PMN Number
    K103352
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 21 AUGUST 2020: LOT 1901442: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 17-APR-2019. EXPIRATION DATE: 2024-04-07. 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. ADDITIONAL IMPLANT INVOLVED: CUP: VERSAFITCUP CC TRIO 01.26.45.0054 ACETABULAR SHELL CC TRIO Ø 54 (K103352) LOT. 1901419. BATCH REVIEW PERFORMED ON 21 AUGUST 2020: LOT 1901419: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10-MAY-2019. EXPIRATION DATE: 2024-04-30. 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. ADDITIONAL IMPLANT INVOLVED: STEM: QUADRA-H 01.12.025 CEMENTLESS, HA COATED STD STEM SIZE 5 (K082792) LOT. 1905392. BATCH REVIEW PERFORMED ON 21 AUGUST 2020: LOT 1905392: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 08-OCT-2019. EXPIRATION DATE: 2024-09-03. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE ALL THE ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ADDITIONAL IMPLANT INVOLVED: BALL HEADS: MECTACER 01.29.204 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 32 SIZE S -4 (K112115) LOT. 1905637. BATCH REVIEW PERFORMED ON 21 AUGUST 2020: LOT 1905637: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03-OCT-2019. EXPIRATION DATE: 2024-09-21. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITH ANOTHER SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    THE PATIENT HAS A LOW GRADE INFECTION WITH STAPHYLOCOCCUS EPIDERMIDIS. 7 MONTHS AFTER PRIMARY THE SURGEON EXPLANTED SUCCESSFULLY ALL THE DEVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    947347 LINER: VERSAFITCUP CC TRIO FLAT PE HC LINER 32 / E ACETABULAR PE LINER LZO MEDACTA INTERNATIONAL SA 01.26.3244HCT 1901442 07630030807572

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention