BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSAFITCUP DM DOUBLE MOBILITY HC LINER Ø 52/28

    MDR report key: 17441293 · Received August 2, 2023

    Report

    Report Number
    3005180920-2023-00621
    Event Type
    Injury
    Date Received
    August 2, 2023
    Date of Event
    July 12, 2023
    Report Date
    August 2, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    MEH
    UDI-DI
    07630030807343
    PMA / PMN Number
    K092265
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON (B)(6) 2023. LOT 2245579: (B)(4) ITEMS MANUFACTURED AND RELEASED ON03-JAN-2023. EXPIRATION DATE: 2027-12-13. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW. ADDITIONAL IMPLANTS INVOLVED, BATCH REVIEW PERFORMED ON (B)(6) 2023: BALL HEADS: MECTACER 01.29.203 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 28 SIZE L +3.5 (K112115) LOT. 2249522: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25-JAN-2023. EXPIRATION DATE: 2028-01-04. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW. AMISTEM-P COLLARED 01.18.432 AMISTEM-P COLLARED STD STEM SIZE 2 (K173794) LOT. 2242521: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 17-FEB-2023. EXPIRATION DATE: 2028-02-01. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    797005 VERSAFITCUP DM DOUBLE MOBILITY HC LINER Ø 52/28 HIP DOUBLE MOBILITY LINER MEH MEDACTA INTERNATIONAL SA 2245579 07630030807343

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention