BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINER: VERSAFITCUP DM DOUBLE MOBILITY HC 56/28

    MDR report key: 12202535 · Received July 21, 2021

    Report

    Report Number
    3005180920-2021-00612
    Event Type
    Injury
    Date Received
    July 21, 2021
    Date of Event
    July 1, 2021
    Report Date
    July 21, 2021
    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 · 1

    BATCH REVIEW PERFORMED ON 08 JULY 2021: LOT 2005002: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 29-JULY-2020. EXPIRATION DATE: 2025-07-13. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT. OTHER DEICE INVOLVED: BATCH REVIEW PERFORMED ON 08 JULY 2021: BALL HEADS: MECTACER 01.29.201 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 28 SIZE S -3.5 (K112115) LOT 2001862: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 01-JULY-2020. EXPIRATION DATE: 2025-06-22. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    THE PATIENT HAD A PRIMARY HIP SURGERY ON (B)(6) 2020. ON (B)(6) 2020, THE PATIENT CAME IN REPORTING PAIN DUE TO A FRACTURE THAT WAS CAUSE FROM FALLING. THE SURGEON CABLED THE FRACTURE AND REVISED THE STEM, HEAD, AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY. PRESENTLY, ON (B)(6) 2021, THE PATIENT CAME IN REPORTING PAIN DUE TO A LEG LENGTH DISCREPANCY. THE CAUSE OF THE LEG LENGTH DISCREPANCY IS UNKNOWN. THE SURGEON REVISED THE MEDACTA HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1099040 LINER: VERSAFITCUP DM DOUBLE MOBILITY HC 56/28 ACETABULAR LINER MEH MEDACTA INTERNATIONAL SA 01.26.2856MHC 2005002 07630030807411

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention