BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINER: VERSAFITCUP DM 01.26.2856MHC DOUBLE MOBILITY HC LINER Ø 56/28

    MDR report key: 17029895 · Received May 31, 2023

    Report

    Report Number
    3005180920-2023-00397
    Event Type
    Injury
    Date Received
    May 31, 2023
    Date of Event
    May 1, 2023
    Report Date
    May 31, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    MEH
    UDI-DI
    07630030807411
    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 11-MAY-2023. LOT 2105782: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18-JUN-2021. EXPIRATION DATE: 2026-06-07. 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. OTHER DEVICES INVOLVED: CUP: MPACT 01.32.156MB DOUBLE MOBILITY ACETABULAR SHELL Ø56 (K143453) LOT 2101494: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06-JUL-2021. EXPIRATION DATE: 2026-06-07. 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. BALL HEADS: COCR 01.25.012 COCR BALL HEAD 12/14 Ø 28 SIZE M 0 (K072857) LOT 2104416: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06-JUL-2021. EXPIRATION DATE: 2026-06-20. 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 YEAR AND 1 MONTH AFTER THE PRIMARY SURGERY, THE PATIENT CAME IN REPORTING PAIN AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE MEDACTA CUP AND LINER WITH COMPETITOR COMPONENTS AND REVISED THE MEDACTA HEAD WITH A MEDACTA HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1830015 LINER: VERSAFITCUP DM 01.26.2856MHC DOUBLE MOBILITY HC LINER Ø 56/28 HIP DOUBLE MOBILITY HC LINER MEH MEDACTA INTERNATIONAL SA 01.26.2856MHC 2105782 07630030807411

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention