BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM H HA COATED STD STEM SIZE 1

    MDR report key: 15154905 · Received August 3, 2022

    Report

    Report Number
    3005180920-2022-00598
    Event Type
    Injury
    Date Received
    August 3, 2022
    Date of Event
    July 13, 2022
    Report Date
    March 8, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030804076
    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 20 JULY 2022: LOT 131567: 60 ITEMS MANUFACTURED AND RELEASED ON 01-JUL-13. EXPIRATION DATE: 2018-MAY-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ADDITIONAL DEVICES INVOLVED: BATCH REVIEWS PERFORMED ON 20 JULY 2022. BALL HEADS: MECTACER 01.29.203 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 28 SIZE L +3.5 (K112115) LOT 131047: 40 ITEMS MANUFACTURED AND RELEASED ON 22-MAY-2013. EXPIRATION DATE: 2018-APR-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 37 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. LINER: VERSAFITCUP DM 01.26.2852MHC DOUBLE MOBILITY HC LINER Ø 52/28 (K092265) LOT 131719: 40 ITEMS MANUFACTURED AND RELEASED ON 15-MAY-2013. EXPIRATION DATE: 2018-MAR-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 39 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. CUP: VERSAFITCUP 01.26.52MB ACETABULAR SHELL CC Ø 52 (K083116) LOT 131688: 55 ITEMS MANUFACTURED AND RELEASED ON 15-MAY-2013. EXPIRATION DATE: 2018-MAR-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 54 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. ABOUT 8 YEARS AND 10 MONTHS AFTER THE PRIMARY SURGERY, THE SURGEON PERFORMED A WASHOUT, REMOVED ALL IMPLANTS, AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    951647 AMISTEM H HA COATED STD STEM SIZE 1 HIP UNCEMENTED STEM LZO MEDACTA INTERNATIONAL SA 01.18.131 131567 07630030804076

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention