BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINER: VERSAFITCUP DM DOUBLE MOBILITY HC LINER 28/DMF

    MDR report key: 10507104 · Received September 9, 2020

    Report

    Report Number
    3005180920-2020-00594
    Event Type
    Injury
    Date Received
    September 9, 2020
    Date of Event
    August 11, 2020
    Report Date
    September 9, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    MEH
    UDI-DI
    07630030807343
    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 02 SEPTEMBER 2020: LOT 1910313: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18-FEB-2020. EXPIRATION DATE: 2025-02-03. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITH ONE SIMILAR EVENT REPORTED. ADDITIONAL IMPLANT INVOLVED: BALL HEADS: MECTACER 01.29.203 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 28 SIZE L +3.5 (K112115) LOT. 1907338. BATCH REVIEW PERFORMED ON 02 SEPTEMBER 2020: LOT 1907338: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 27-JAN-2020. EXPIRATION DATE: 2025-01-14. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ADDITIONAL IMPLANT INVOLVED: CUP: MPACT 01.32.154MB DOUBLE MOBILITY ACETABULAR SHELL Ø54 (K143453) LOT. 1909303. BATCH REVIEW PERFORMED ON 02 SEPTEMBER 2020: LOT 1909303: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 17-MAR-2020. EXPIRATION DATE: 2025-03-09. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ADDITIONAL IMPLANT INVOLVED: STEM: AMISTEM C 01.18.103 CEMENTED LAT STEM SIZE 3 (K103189) LOT. 188725. BATCH REVIEW PERFORMED ON 02 SEPTEMBER 2020: LOT 188725: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 17-JAN-2019. EXPIRATION DATE: 2023-12-19. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY 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 DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN WAS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY. PRESENTLY, ON (B)(6) 2020, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE HEAD, LINER, CUP, AND STEM. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    973599 LINER: VERSAFITCUP DM DOUBLE MOBILITY HC LINER 28/DMF ACETABULAR DOUBLE MOBILITY LINER MEH MEDACTA INTERNATIONAL SA 01.26.2852MHC 1910313 07630030807343

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention