BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSAFITCUP DM DOUBLE MOBILITY HC LINER Ø 50/28

    MDR report key: 17690081 · Received September 6, 2023

    Report

    Report Number
    3005180920-2023-00689
    Event Type
    Injury
    Date Received
    September 6, 2023
    Date of Event
    August 11, 2023
    Report Date
    September 6, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    MEH
    UDI-DI
    07630030807282
    PMA / PMN Number
    K092265
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 06-SEP-2023. LOT 2236018: 55 ITEMS MANUFACTURED AND RELEASED ON 18-OCT-2022. EXPIRATION DATE: 2027-09-29. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 48 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW. ADDITIONAL IMPLANT INVOLVED, BATCH REVIEW PERFORMED ON 06-SEP-2023. CUP: MPACT 01.32.156MH ACETABULAR SHELL Ø56 MULTI-HOLE (K132879) LOT 2213428: 32 ITEMS MANUFACTURED AND RELEASED ON 05-OCT-2022. EXPIRATION DATE: 2027-09-25. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 10 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    THE PATIENT HAD A PRIMARY HIP SURGERY ON (B)(6) 2023. SOON AFTER THE PRIMARY HIP SURGERY, THE PATIENT SUSTAINED A DISLOCATION OF THE HEAD FROM THE LINER. THE SURGEON REVISED ALL IMPLANTS SUCCESSFULLY. PRESENTLY, ON (B)(6) 2023, THE PATIENT CAME IN REPORTING PAIN DUE TO JOINT LUXATION (DISLOCATION OF THE HEAD AND LINER FROM THE CUP) AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE HEAD AND LINER SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    918876 VERSAFITCUP DM DOUBLE MOBILITY HC LINER Ø 50/28 HIP LINER MEH MEDACTA INTERNATIONAL SA 2236018 07630030807282

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male Required Intervention