BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 8780239 · Received July 11, 2019

    Report

    Report Number
    3005180920-2019-00567
    Event Type
    Injury
    Date Received
    July 11, 2019
    Date of Event
    June 18, 2019
    Report Date
    July 11, 2019
    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 26 JUNE 2019: LOT 178327: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 21-MAR-2018. EXPIRATION DATE: 2023-03-06. 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. OTHER DEVICES WERE INVOLVED IN THE EVENT: BATCH REVIEW PERFORMED ON 26 JUNE 2019: CUP: VERSAFITCUP 01.26.56MB VERSAFITCUP DM CUP 56MM LOT 171693 (K083116): (B)(4) ITEMS MANUFACTURED AND RELEASED ON 27-SET-2017. EXPIRATION DATE: 2022-09-18. 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. STEM: QUADRA-C 01.12.043 CEMENTED, MIRROR POLISHING STD STEM SIZE 3 12/14, LOT 153003 (K083558): (B)(4) ITEMS MANUFACTURED AND RELEASED ON 08-SET-2015. EXPIRATION DATE: 2020-08-16. 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. BALL HEADS: COCR 01.25.015 COCR BALL HEAD 12/14 Ø 28 SIZE XXL +10.5 LOT 161627 (K072857): (B)(4) ITEMS MANUFACTURED AND RELEASED ON 07-APR-2016. EXPIRATION DATE: 2021-03-28. 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

    ON (B)(6) WE WERE INFORMED ABOUT A REVISION SURGERY PERFORMED ON (B)(6), AFTER 1 YEAR FROM THE PRIMARY DUE TO AND INFECTION (THE PATHOGEN IS UNKNOWN). THE SURGEON PERFORMED A WASHOUT AND REMOVED ALL IMPLANTS AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    575001 LINER: VERSAFITCUP DM DOUBLE MOBILITY HC LINER Ø 56/28 DOUBLE MOBILITY HC LINER MEH MEDACTA INTERNATIONAL SA 178327 07630030807411

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention