BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: AMISTEM H HA COATED STD STEM SIZE 5

    MDR report key: 15542037 · Received October 5, 2022

    Report

    Report Number
    3005180920-2022-00754
    Event Type
    Injury
    Date Received
    October 5, 2022
    Date of Event
    September 12, 2022
    Report Date
    December 15, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030804113
    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 (B)(6) 2022, LOT 111244: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06-JUNE-2011. EXPIRATION DATE: 2016-04-30. 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 INVOLVED IMPLANTS: BATCH REVIEW PERFORMED ON (B)(6) 2022 ON BALL HEADS: MECTACER 38.39.7175.245.00 BIOLOX FORTE CERAMIC BALL HEAD 12/14 Ø 28 SIZE S -3.5 (USA) (K073337) LOT. 113905. LOT 113905: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 21-OCT-2011. EXPIRATION DATE: 2016-08-31. 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. BATCH REVIEW PERFORMED ON (B)(6) 2022 ON CUP: VERSAFITCUP 01.26.54MB ACETABULAR SHELL Ø 54 (K083116) LOT. 111514. LOT 111514: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 09-AUG-2011. EXPIRATION DATE: 2016-06-30. 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. BATCH REVIEW PERFORMED ON (B)(6) 2022 ON LINER: VERSAFITCUP DM 01.26.2854MHC DOUBLE MOBILITY HC LINER Ø 54/28 (K092265) LOT. 112474. LOT 112474: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 09-AUG-2011. EXPIRATION DATE: 2016-06-30. 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.

    Additional Manufacturer Narrative · 0

    ON 29 NOVEMBER 2022, IT WAS COMMUNICATED THAT ON (B)(6) 2022, THE SURGEON REMOVED THE ANTIBIOTIC SPACER AND IMPLANTED THE PERMANENT HARDWARE.

    Description of Event or Problem · 0

    AT ABOUT 10 YEARS AND 10 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT, REMOVED ALL IMPLANTS, AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Description of Event or Problem · 0

    THE PATIENT HAD A PRIMARY KNEE SURGERY ON (B)(6) 2011. ON (B)(6) 2022, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT, REMOVED ALL IMPLANTS, AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY. PRESENTLY, ON (B)(6) 2022, THE SURGEON REMOVED THE ANTIBIOTIC SPACER AND IMPLANTED THE PERMANENT HARDWARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2598905 STEM: AMISTEM H HA COATED STD STEM SIZE 5 HIP STEM LZO MEDACTA INTERNATIONAL SA 01.18.135 111244 07630030804113

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention