BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUP: VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO Ø 48

    MDR report key: 16761590 · Received April 18, 2023

    Report

    Report Number
    3005180920-2023-00273
    Event Type
    Injury
    Date Received
    April 18, 2023
    Date of Event
    March 22, 2023
    Report Date
    April 18, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030807756
    PMA / PMN Number
    K103352
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 31-MAR-2023. LOT 133037: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13-SEP-2013. EXPIRATION DATE: 2018-08-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DEPARTMENT: REVISION 8 YEARS AND 10 MONTHS AFTER PRIMARY OPERATION, DUE TO STEM LOOSENING. ACCORDING TO REPORT THE REASON MAY BE A LATE INFECTION. 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 ITEMS INVOLVED IN THE EVENT, BATCH REVIEW PERFORMED ON 31-MAR-2023: LINER: VERSAFITCUP CC TRIO 01.26.3239HCT FLAT PE HC LINER Ø 32 / C (K120531) LOT. 136289 LOT 136289: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10-FEB-2014. EXPIRATION DATE: 2018-12-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW. BALL HEADS: COCR 01.25.021 COCR BALL HEAD 12/14 Ø 32 SIZE S -3.5 (K072857) LOT. 124254 LOT 124254: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 04-DEC-2012. EXPIRATION DATE: 2017-10-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW. STEM: QUADRA-H 01.12.20SN CEMENTLESS, HA COATED STD STEM SIZE 0, SHORT NECK (K082792) LOT. 132362 LOT 132362: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22-JUL-2013. EXPIRATION DATE: 2018-06-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    ALL RIGHT HIP COMPONENTS REVISED ABOUT 8 YEARS AND 10 MONTHS AFTER THE PRIMARY SURGERY, DUE TO LOOSENING OF THE FEMORAL STEM, LIKELY CAUSED BY AN INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1032957 CUP: VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO Ø 48 HIP AETABULAR SHELL LZO MEDACTA INTERNATIONAL SA 01.26.45.0048 133037 07630030807756

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Female Required Intervention