BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUADRA-C CEMENTED, MIRROR POLISHED STD STEM SIZE 3

    MDR report key: 8310175 · Received February 6, 2019

    Report

    Report Number
    3005180920-2019-00029
    Event Type
    Injury
    Date Received
    February 6, 2019
    Date of Event
    January 8, 2019
    Report Date
    February 6, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030802812
    PMA / PMN Number
    K103189
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 05 FEBRUARY 2019: LOT 171594: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 09-MAY-2017. EXPIRATION DATE: 2022-04-24. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THIS SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. OTHER DEVICES INVOLVED: VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO NO-HOLE Ø 50 REFERENCE 01.26.45.1150 (K122911). LOT 180113: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26-APR-2018. EXPIRATION DATE: 2023-04-16. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THIS SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. LINER CC E CC LIGHT FLAT PE HC LINER Ø 36/ E 01.26.3644HCT (K120531). LOT 176658: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 30-JAN-2018. EXPIRATION DATE: 2023-01-11. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THIS SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. COCR BALL HEAD 12/14 Ø 36 SIZE S -3.5 (K080885). LOT 157529: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 01-MAR-2016. EXPIRATION DATE: 2021-02-16. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THIS SAME LOT HAVE BEEN ALREADY SOLD WITH ANOTHER SIMILAR REPORTED EVENT. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS MANAGER ON JANUARY 11, 2019. EARLY INFECTION IN CEMENTED THA, 2 MONTHS AFTER PRIMARY OPERATION. INFECTION IS A KNOWN POSSIBLE ADVERSE EVENT FOLLOWING EVERY SURGERY, INCLUDING THA'S. TO DATE, THERE IS NO REASON TO SUSPECT THAT THE CAUSE MAY BE LINKED TO THE IMPLANTED DEVICES.

    Description of Event or Problem · 1

    THE PATIENT WAS SEPTIC SO THE SURGEON REVISED ALL IMPLANTED DEVICES TWO MONTHS AFTER PRIMARY SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    102409 QUADRA-C CEMENTED, MIRROR POLISHED STD STEM SIZE 3 CEMENTED HIP STEM LZO MEDACTA INTERNATIONAL SA 171594 07630030802812

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Required Intervention