BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM H HA COATED STD STEM SIZE 3

    MDR report key: 16596964 · Received March 23, 2023

    Report

    Report Number
    3005180920-2023-00200
    Event Type
    Injury
    Date Received
    March 23, 2023
    Date of Event
    March 2, 2023
    Report Date
    March 23, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030804090
    PMA / PMN Number
    K093944
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 09 MARCH 2023: LOT 153422: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 23-SEP-2015. EXPIRATION DATE: 2020-09-08. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ADDITIONAL DEVICES INVOLVED BATCH REVIEW PERFORMED ON 09 MARCH 2023: BALL HEADS: MECTACER 01.29.204 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 32 SIZE S -4 (K112115) LOT 152607: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 29-SEP-2015. EXPIRATION DATE: 2020-08-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. CUP: MPACT 01.32.150DH ACETABULAR SHELL Ø50 TWO-HOLES (K132879) LOT 153883: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 19-OCT-2015. EXPIRATION DATE: 2020-10-05. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. LINER: MPACT 01.32.3241HCT FLAT PE HC LINER Ø32/D (K103721) LOT 150738: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05-AUG-2015. EXPIRATION DATE: 2020-06-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    AT ABOUT 7 YEARS 4 MONTHS AFTER THE SURGERY, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT, REMOVED ALL COMPONENTS AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    479952 AMISTEM H HA COATED STD STEM SIZE 3 HIP CEMENTLESS STEM LZO MEDACTA INTERNATIONAL SA 01.18.133 153422 07630030804090

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention