BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: AMISTEM H HA COATED LAT STEM SIZE 1

    MDR report key: 8544517 · Received April 24, 2019

    Report

    Report Number
    3005180920-2019-00302
    Event Type
    Injury
    Date Received
    April 24, 2019
    Date of Event
    March 25, 2019
    Report Date
    April 24, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030804175
    PMA / PMN Number
    K093944
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION PROVIDED BY THE AGENT ON 05.APRIL.2019: DURING STEM EXTRACTION OCCURRED A COMPLICATION, THE LARGE TROCHANTER BROKE (CERCLAGE), PROBABLY DUE TO A BAD QUALITY BONE. ONLY STEM AND BALL HEAD WERE EXPLANTED DURING THE REVISION SURGERY. BATCH REVIEW PERFORMED ON 23 APRIL 2019. LOT 161434: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 16-JUN-2016. EXPIRATION DATE: 2021-05-26. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS MANAGER: PARTIAL HIP REVISION SURGERY (STEM AND HEAD) OCCURRED 2 YEARS AFTER TOTAL HIP ARTHROPLASTY IN A (B)(6) YEAR OLD, (B)(6) KG MAN COMPLAINING ABOUT PAIN AND INSTABILITY. RADIOGRAPHIC IMAGE PROVIDED SHOWS A LOW RESECTION HEIGHT BUT THE RELATION OF THIS FINDING WITH PATIENT SYMPTOMS IS NOT CLEAR. NO SIGN OF RADIOLOGICAL MOBILIZATION IS VISIBLE IN THIS PROJECTION. THE REASON OF THIS EVENT CANNOT BE DETERMINED. VISUAL INSPECTION PERFORMED BY R&D PROJECT MANAGER: FEMORAL STEM AND NECK SHOW SIGNS OF EXTRACTION. BONE RESIDUAL ON THE DISTAL PART OF THE STEM. SOME HA REMAINING ON THE PROXIAMAL PART. IT IS NOT POSSIBLE TO DETERMINE IMPLANTS-RELATED FAILURE ROOT CAUSE.

    Description of Event or Problem · 1

    REVISION SURGERY AFTER 2 YEARS AND 1 MONTH FROM THE PRIMARY DUE TO PAIN AND INSTABILITY (RADIOLUCENCIES OF AN AMISTEM HA COATED 1 LATERALIZED CEMENTLESS WERE DETECTED). REVISION SURGERY PERFORMED IMPLANTING A QUADRA-C STEM 1 LATERALIZED + PLUG 1.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    336907 STEM: AMISTEM H HA COATED LAT STEM SIZE 1 CEMENTLESS HIP STEM LZO MEDACTA INTERNATIONAL SA 161434 07630030804175

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention