BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUP: VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO Ø 56

    MDR report key: 12809542 · Received November 15, 2021

    Report

    Report Number
    3005180920-2021-00884
    Event Type
    Injury
    Date Received
    November 15, 2021
    Date of Event
    September 30, 2021
    Report Date
    November 15, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030807794
    PMA / PMN Number
    K103352
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 26 OCTOBER 2021: LOT 178360: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03-APR-2018. EXPIRATION DATE: 2023-03-20. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ADDITIONAL IMPLANT INVOLVED: LINER: CC E CC LIGHT 01.26.3248HCAT HOODED PE HC FIXED LINER Ø 32 / F (K103352) LOT. 181147. BATCH REVIEW PERFORMED ON 26 OCTOBER 2021: LOT 181147: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 04-JUN-2018. EXPIRATION DATE: 2023-05-15. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ADDITIONAL IMPLANT INVOLVED: STEM: AMISTEM H 01.18.135 HA COATED STD STEM SIZE 5 (K093944) LOT. 180763. BATCH REVIEW PERFORMED ON 26 OCTOBER 2021: LOT 180763: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20-JUN-2018. EXPIRATION DATE: 2023-06-10. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ADDITIONAL IMPLANT INVOLVED: BALL HEADS: MECTACER 01.29.205 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 32 SIZE M 0 (K112115) LOT. 183346. BATCH REVIEW PERFORMED ON 26 OCTOBER 2021: LOT 183346: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 04-SEP-2018. EXPIRATION DATE: 2023-08-21. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 0

    REVISION SURGERY ABOUT 2 YEARS AND 10 MONTHS AFTER PRIMARY DUE TO HIP INFECTION. DURING REVISION IT WAS FOUND THAT THE STEM WAS LOOSE. ANTIBIOTIC SPACER IMPLANTED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1714039 CUP: VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO Ø 56 CEMENTLESS ACETABULAR CUP LZO MEDACTA INTERNATIONAL SA 01.26.45.0056 178360 07630030807794

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Unknown Required Intervention