BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM H, HA COATED STEM SIZE 3 STD

    MDR report key: 5717263 · Received June 10, 2016

    Report

    Report Number
    3005180920-2016-00275
    Event Type
    Injury
    Date Received
    June 10, 2016
    Date of Event
    May 4, 2016
    Report Date
    July 12, 2016
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    PMA / PMN Number
    K093944
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AT REVISION SURGERY, SAME DAY OF THE PRIMARY, IT WAS IMPLANTED AN AMISTEM C, CEMENTED STEM SIZE 1 STD, CODE 01.18.151, LOT. 120536 (K103189). THE PATIENT FELL IN THE NIGHT BETWEEN (B)(6) 2016, WHICH CAUSED A SPIRAL FRACTURE OF THE FEMUR. AN ADDITIONAL SURGERY WAS THEN PERFORMED ON (B)(6) 2016, TREATED WITH PLATE AND SCREWS (NO IMPLANTS REVISED). THE SURGERY WAS COMPLETED SUCCESSFULLY. BATCH REVIEW PERFORMED ON 06 JUNE 2016. LOT 156232: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 02 MARCH 2016. EXPIRATION DATE: 2021-02-16. 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. AMISTEM C, CEMENTED STEM SIZE 1 STD, CODE 01.18.151, LOT. 120536 (K103189) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28 MARCH 2012. EXPIRATION DATE: 2017-02-28. 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. ON 10 JUNE 2016 THE MEDICAL AFFAIRS DIRECTOR PERFORMED A CLINICAL EVALUATION AND COMMENTED AS FOLLOWS: TWO SEPARATE EVENTS ARE REPORTED: A PER-OPERATIVE FRACTURE AND A SUBSEQUENT TRAUMATIC FRACTURE. FOR THE FIRST ONE, IT IS KNOWN THAT DURING FEMUR PREPARATION A FRACTURE CAN OCCUR. THIS IS NOT NECESSARILY DUE TO A PROBLEM WITH THE PREPARATION INSTRUMENTS, IT DEPENDS MAINLY ON BONE QUALITY. IN THIS CASE, NO MENTION OF A DEFECTIVE INSTRUMENT WAS MADE. THE SUBSEQUENT TRAUMA, ORIGINATED BY A FALL, IS APPARENTLY NOT RELATED TO A DEVICE PERFORMANCE.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED ON 12 JUNE 2016 FROM THE INITIAL REPORTER AND INCLUDES: THE EXPLANT IS NOT AVAILABLE. ON 13 JUNE 2016 IT WAS PREPARED A FINAL REPORT WITH THE INFORMATION SUBMITTED IN THIS REPORT AND IN THE INITIAL ONE. ON 28 JUNE 2016 THE REPORT WAS SENT TO THE INITIAL REPORTER AND THE CASE WAS CLOSED.

    Description of Event or Problem · 1

    REVISION SURGERY DUE TO PER-OPERATIVE BONE FRACTURE TREATED WITH CERCLAGE AND STEM REPLACEMENT. THE OPERATION WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    371646 AMISTEM H, HA COATED STEM SIZE 3 STD CEMENTLESS FEMORAL STEM LZO MEDACTA INTERNATIONAL SA 156232

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention