BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUP: VERSAFITCUP CC TRIO ACETABULAR SHELL Ø 56

    MDR report key: 12998610 · Received December 14, 2021

    Report

    Report Number
    3005180920-2021-00976
    Event Type
    Injury
    Date Received
    December 14, 2021
    Date of Event
    November 16, 2021
    Report Date
    December 14, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030807794
    PMA / PMN Number
    K103352
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 23 NOVEMBER 2021. LOT 1901423: (B)(4). EXPIRATION DATE: 2024-MAY-25. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT. CLINICAL EVALUATION: INFECTION IN CEMENTLESS THA. 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. ANOTHER DEVICES INVOLVED: BATCH REVIEW PERFORMED ON 23 NOVEMBER 2021: LINER: MECTACER 01.29.414 CERAMIC LINER Ø 36 / F (NOT REGISTERED IN USA) LOT 1904667: (B)(4). EXPIRATION DATE: 2024-AUG-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. (B)(4). STEM: AMISTEM P 01.18.415 AMISTEM-P LAT STEM SIZE 5 (K173794)LOT 1904149: (B)(4). EXPIRATION DATE: 2024-JUL-24. NO ANOMALIES FOUND RELATED TO THE PROBLEM. (B)(4). BALL HEADS: MECTACER 01.29.209 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE M 0 (K112115) LOT 1903861: (B)(4). EXPIRATION DATE: 2024-JUL-17. NO ANOMALIES FOUND RELATED TO THE PROBLEM. (B)(4).

    Description of Event or Problem · 0

    THE PRIMARY SURGERY TOOK PLACE IN 2020 (THE EXACT DATE IS UNKNOWN). REVISION SURGERY PERFORMED ON (B)(6) 2021 BECAUSE OF A LOW-GRADE INFECTION AND OSTEOPOROSIS. ALL IMPLANTS REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1901502 CUP: VERSAFITCUP CC TRIO ACETABULAR SHELL Ø 56 ACETABULAR SHELL LZO MEDACTA INTERNATIONAL SA 01.26.45.0056 1901423 07630030807794

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention