BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: AMISTEM P AMISTEM-P STD STEM SIZE 2

    MDR report key: 15074525 · Received July 21, 2022

    Report

    Report Number
    3005180920-2022-00546
    Event Type
    Injury
    Date Received
    July 21, 2022
    Date of Event
    June 23, 2022
    Report Date
    July 21, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630040720014
    PMA / PMN Number
    K173794
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 24 JUNE 2022 LOT 2009272: LOT 2009272: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 11-JAN-2021. EXPIRATION DATE: 2025-DEC-20. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. CLINICAL EVALUATION: REVISION PERFORMED 1 YEAR AND 1 MONTH AFTER PRIMARY THA IN A 73 YEAR-OLD PATIENT. AS REPORTED, THE PATIENT WAS IN PAIN DUE TO STEM AND CUP LOOSENING. DURING THE REVISION BOTH IMPLANTS WERE REMOVED AND REPLACED WITH M-VIZION IMPLANTS. NO INFORMATION CONCERNING PATIENT GENERAL HEALTH STATUS AND THE PRESENCE OF COMORBIDITIES IS AVAILABLE. IN THE RADIOGRAPHIC IMAGE PROVIDED,PRIMARY STEM APPEARS TO BE UNDERSIZED POSSIBLY DUE TO A VARUS POSITION. THIS CONDITION MAY HAVE PREVENTED THE STEM FROM FINDING A RELIABLE STABILITY. A RATHER LARGE CUP WAS ALSO USED BUT WE CAN NOT DETERMINE ITS ROLE IN THE NECESSITY FOR REPLACEMENT. NO REASON TO SUSPECT A DEFECTIVE IMPLANT AT THE ORIGIN OF THIS ADVERSE EVENT. ADDITIONAL IMPLANTED COMPONENTS: BATCH REVIEW PERFORMED ON 24 JUNE 2022 ON CUP: VERSAFITCUP CC TRIO 01.26.45.0052 ACETABULAR SHELL CC TRIO Ø 52 (K103352) LOT. 2010282: LOT 2010282: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 01-MAR-2021. EXPIRATION DATE: 2025-DEC-17. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    REVISION SURGERY PERFORMED DUE TO STEM AND CUP LOOSENING 1 YEAR AND 1 MONTH AFTER THE PRIMARY SURGERY. NO INFECTION DETECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1698880 STEM: AMISTEM P AMISTEM-P STD STEM SIZE 2 HIP STEM LZO MEDACTA INTERNATIONAL SA 01.18.402 2009272 07630040720014

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male Required Intervention