BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: M-VIZION PROXIMAL BODY 20MM L 50MM LAT

    MDR report key: 11371403 · Received February 24, 2021

    Report

    Report Number
    3005180920-2021-00135
    Event Type
    Injury
    Date Received
    February 24, 2021
    Date of Event
    January 26, 2021
    Report Date
    February 24, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030877148
    PMA / PMN Number
    K170690
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 23-FEB-2021. LOT 155512: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 30-MAR-2017. EXPIRATION DATE: 2021-10-19. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD. NO OTHER SIMILAR EVENTS HAVE BEEN REPORTED SINCE 2017. ADDITIONAL IMPLANT INVOLVED: STEM: M-VIZION 01.22.164 DISTAL STEM Ø15MM L 220MM STRAIGHT (K191816) LOT. 1901251. BATCH REVIEW PERFORMED ON 23-FEB-2021. LOT 1901251: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 30-OCT-2019. EXPIRATION DATE: 2024-10-20. NO ANOMALIES FOUND RELATED TO THE PROBLEM TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD. NO OTHER SIMILAR EVENTS HAVE BEEN REPORTED. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DIRECTOR. HIP REVISION SURGERY PERFORMED 6 MONTHS AFTER IMPLANTATION OF A MODULAR CEMENTLESS STEM IN A DIFFICULT CASE WITH SIGNIFICANT BONE LOSS AND A PARTIALLY RESECTED FEMUR. THE PATIENT REPORTED PAIN AND INSTABILITY PROBABLY DUE TO LEG LENGTH DISCREPANCY. EARLY STEM SUBSIDENCE MAY BE CAUSED BY UNDERSIZING OR POOR BONE QUALITY: IN THIS DIFFICULT CASE SIZING IS EXTREMELY DIFFICULT AS THE PURCHASE OF THE STEM IN THE CANAL IS VERY DISHOMOGENEOUS, SO IT MAY BE HOLDING IN A VERY LIMITED SECTION WHICH MAY THEN GIVE WAY ONCE LOADING IS APPLIED. RADIOGRAPHIC IMAGES PROVIDED DON'T ALLOW A FULL EVALUATION OF THE CASE. NO REASON TO SUSPECT A DEFECTIVE DEVICE.

    Description of Event or Problem · 1

    THE PATIENT CAME IN REPORTING PAIN AND INSTABILITY ABOUT 7 MONTHS AFTER PRIMARY. POST-OP X-RAYS INDICATED THAT THE STEM HAD SUBSIDED AND A PHYSICAL EXAMINATION REVEALED A LEG LENGTH DISCREPANCY OF GREATER THAN 1 CM. THE SURGEON REVISED THE PROXIMAL BODY Ø20MM L 50MM LAT WITH A 01.22.030 PROXIMAL BODY Ø24MM L 70MM LAT AND REVISED THE 40MM BIOLOX DELTA HEAD XL WITH A 01.29.213 40MM BIOLOX DELTA HEAD M. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE PATIENT HAD GOOD BONE QUALITY. THE SURGEON KEPT IN THE ORIGINAL DISTAL STEM FROM THE PRIMARY (01.22.164 DISTAL STEM Ø15MM L 220MM STRAIGHT 1901251) . THE DISTAL REAMER USED WAS A SIZE -15MM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270272 STEM: M-VIZION PROXIMAL BODY 20MM L 50MM LAT REVISION CEMENTLESS HIP STEM LZO MEDACTA INTERNATIONAL SA 01.22.008 155512 07630030877148

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention