BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUP: VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO Ø 62

    MDR report key: 9075828 · Received September 17, 2019

    Report

    Report Number
    3005180920-2019-00778
    Event Type
    Injury
    Date Received
    September 17, 2019
    Date of Event
    August 23, 2019
    Report Date
    September 17, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030807824
    PMA / PMN Number
    K103352
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON (B)(6) 2019; LOT 176990: (B)(4) ITEMS MANUFACTURED AND RELEASED ON (B)(6) 2018. EXPIRATION DATE: 2023-02-07. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. CLINICAL EVALUATION PERFORMED BY MEDACTA MEDICAL AFFAIRS DIRECTOR DELAYED INFECTION IN CEMENTLESS THA, 11 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. ADDITIONAL DEVICES INVOLVED: BATCH REVIEWS PERFORMED ON (B)(6) 2019: QUADRA-H 01.12.028 CEMENTLESS, (B)(6) (K082792) LOT 041380/T: (B)(4) ITEMS MANUFACTURED AND RELEASED ON (B)(6) 2015. EXPIRATION DATE: 2020-01-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) OF THE SAME LOT HAVE BEEN ALREADY SOLD. MECTACER 01.29.208 BIOLOX DELTA CERAMIC BALL HEAD 12/14 (B)(6) (K112115) LOT 180538: (B)(4) ITEMS MANUFACTURED AND RELEASED ON (B)(6) 2018. EXPIRATION DATE: 2023-06-06. 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

    PATIENT HAD AN INFECTED HIP. WE WERE INFORMED ON THE (B)(6) 2019 OF THE REVISION SURGERY PLANNED AND PERFORMED ON THE (B)(6) 2019, 11 MONTHS AFTER PRIMARY. ALL COMPONENTS HAVE BEEN REMOVED. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    871781 CUP: VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO Ø 62 UNCEMETED HIP SHELL LZO MEDACTA INTERNATIONAL SA 176990 07630030807824

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention