BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM H, HA COATED STEM SIZE 3 STD

    MDR report key: 5991542 · Received September 30, 2016

    Report

    Report Number
    3005180920-2016-00499
    Event Type
    Injury
    Date Received
    September 30, 2016
    Date of Event
    August 30, 2016
    Report Date
    December 28, 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

    ADDITIONAL INFORMATION RECEIVED FROM THE INITIAL REPORTER ON 07 SEPTEMBER 2016 AND INCLUDES: IN (B)(6), THE PATIENT'S HIP DISLOCATED AND THE REDUCTION OF THE LUXATION WAS PERFORMED IN ANOTHER HOSPITAL. THE LUXATION WAS DUE TO OVER WEIGHT OF PATIENT. THEN, THE PATIENT CAME IN AND HAD AN INFECTION, PROBABLY DUE TO HEMATOMA POST-LUXATION, HAS BEEN DETECTED FEW DAYS BEFORE REVISION SURGERY. THE SURGEON DECIDED TO REPLACE ALL THE IMPLANTS IN ONE TIME. THE PATHOGEN IS CONFIRMED AS STAPHYLOCOCCUS DOREUS. BATCH REVIEWS PERFORMED ON 28 SEPTEMBER 2016. LOT 155652: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26 JANUARY 2016. EXPIRATION DATE: 2021-01-10. 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. VERSAFITCUP CC TRIO ACETABULAR SHELL Ø 56, CODE 01.26.45.0056, LOT. 157088 (K103352) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 23 MARCH 2016. EXPIRATION DATE: 2021-03-13. 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. VERSAFITCUP FLAT PE HC LINER Ø 32 / F, CODE 01.26.3248HCT, LOT. 156961 (K103352) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10 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. COCR BALL HEAD 12/14 Ø 32 SIZE L +3.5, CODE 01.25.023, LOT. 156349 (K072857) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 01 FEBRUARY 2016. EXPIRATION DATE: 2021-01-19. 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. NOT YET RECEIVED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED ON 28 NOVEMBER 2016 AND INCLUDES: CONTRARY TO WHAT PREVIOUSLY REPORTED, IT WAS CONFIRMED THAT THE EXPLANTS WILL NOT BECOME AVAILABLE.

    Description of Event or Problem · 1

    HIP REVISION FOR INFECTION PROBABLY DUE TO HAEMOTMAE POST-LUXATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    643638 AMISTEM H, HA COATED STEM SIZE 3 STD CEMENTLESS FEMORAL STEM LZO MEDACTA INTERNATIONAL SA 155652

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention