BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM COLLARED STEM, HA COATED SIZE 6 STD

    MDR report key: 6851066 · Received September 8, 2017

    Report

    Report Number
    3005180920-2017-00505
    Event Type
    Injury
    Date Received
    September 8, 2017
    Date of Event
    August 10, 2017
    Report Date
    September 8, 2017
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030804618
    PMA / PMN Number
    K121011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON 25 AUGUST 2017 THE MEDICAL AFFAIRS PERFORMED A CLINICAL EVALUATION AND COMMENTED AS FOLLOWS: LATE INFECTION IN CEMENTLESS THA, 2 YEARS AFTER PRIMARY OPERATION. INFECTION IS A KNOWN POSSIBLE ADVERSE EVENT FOLLOWING EVERY SURGERY, INCLUDING THA'S. TO DATE, THERE IS NO REASON TO SUSPECT THAT THE CAUSE MAY BE LINKED TO THE IMPLANTED DEVICES. BATCH REVIEWS PERFORMED ON 04 SEPTEMBER 2017. LOT 146198: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13 JANUARY 2015. EXPIRATION DATE: 2019-11-30. 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. MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 28 SIZE S -3.5, CODE 01.29.201, LOT. 151720 (K112115) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 29 SEPTEMBER 2015. EXPIRATION DATE: 2020-08-31. 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 ACETABULAR SHELL Ø 54, CODE 01.26.54MB, LOT. 152020 (K083116) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26 AUGUST 2015. EXPIRATION DATE: 2020-06-30. 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 DOUBLE MOBILITY HC LINER Ø 54/28, CODE 01.26.2854MHC, LOT. 152103 (K092265) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 24 AUGUST 2015. EXPIRATION DATE: 2020-06-30. 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.

    Description of Event or Problem · 1

    THE PATIENT CAME IN DUE TO SIGNS OF INFECTION (LEFT HIP). THE PATHOGEN IS UNKNOWN. THE INFECTION CAUSED THE STEM TO BECOME LOOSE. THE SURGEON REVISED ALL MEDACTA HARDWARE AND RE-IMPLANTED PERMANENT PRODUCT. THE SURGERY WAS COMPLETED SUCCESSFULLY. X-RAYS ARE AVAILABLE. EXPLANTS ARE NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    631449 AMISTEM COLLARED STEM, HA COATED SIZE 6 STD CEMENTLESS FEMORAL STEM LZO MEDACTA INTERNATIONAL SA 146198 07630030804618

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention