BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM H 01.18.134 HA COATED STD STEM SIZE 4

    MDR report key: 8878375 · Received August 9, 2019

    Report

    Report Number
    3005180920-2019-00663
    Event Type
    Injury
    Date Received
    August 9, 2019
    Date of Event
    July 15, 2019
    Report Date
    August 9, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030804106
    PMA / PMN Number
    K093944
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 17 JULY 2019: LOT 172609: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26-SEPTEMBER-2017. EXPIRATION DATE: 2022-09-17. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. ADDITIONAL IMPLANTS: BALL HEADS: COCR 01.25.011 COCR BALL HEAD 12/14 Ø 28 SIZE S -3.5 LOT. 171772 (K072857). BATCH REVIEW PERFORMED ON 17 JULY 2019: LOT 171772: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 31-JULY-2017. EXPIRATION DATE: 2022-07-16. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. LINER: VERSAFITCUP DM 01.26.2848MHC DOUBLE MOBILITY HC LINER Ø 48/28 LOT. 174321 (K092265). BATCH REVIEW PERFORMED ON 17 JULY 2019: LOT 174321: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03-NOVEMBER-2017. EXPIRATION DATE: 2022-10-18. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT 2 OTHER SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE HEAD, STEM AND LINER ABOUT 1 YEAR AND 7 MONTH AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    672807 AMISTEM H 01.18.134 HA COATED STD STEM SIZE 4 HIP CEMENTLESS STEM LZO MEDACTA INTERNATIONAL SA 172609 07630030804106

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention