BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUP: VERSAFITCUP ACETABULAR SHELL 48

    MDR report key: 11398506 · Received March 2, 2021

    Report

    Report Number
    3005180920-2021-00154
    Event Type
    Injury
    Date Received
    March 2, 2021
    Date of Event
    February 1, 2021
    Report Date
    February 3, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    MEH
    UDI-DI
    07630030808036
    PMA / PMN Number
    K083116
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 01 MARCH 2021: LOT 153606: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 23-SEP-2015. EXPIRATION DATE: 2020-08-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD. NO OTHER SIMILAR EVENTS HAVE BEEN REPORTED SINCE 2017. ANOTHER DEVICES INVOLVED: BATCH REVIEW PERFORMED ON 01 MARCH 2021: BALL HEADS: MECTACER 01.29.201 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 28 SIZE S -3.5 (K112115). LOT. 154923: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 09-DEC-2015. EXPIRATION DATE: 2020-11-23. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD. NO OTHER SIMILAR EVENTS HAVE BEEN REPORTED SINCE 2017. BATCH REVIEW PERFORMED ON 01 MARCH 2021: LINER: VERSAFITCUP DM 01.26.2848MHC DOUBLE MOBILITY HC LINER Ø 48/28 (K092265)LOT. 152688: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 08-SEP-2015. EXPIRATION DATE: 2020-06-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD. NO OTHER SIMILAR EVENTS HAVE BEEN REPORTED SINCE 2017.

    Description of Event or Problem · 1

    THE PATIENT CAME IN REPORTING PAIN 4 YEARS 11 MONTHS AFTER THE PRIMARY AND THE CAUSE OF THE PAIN IS UNKNOWN. THE SURGEON REVISED THE CUP, HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    297472 CUP: VERSAFITCUP ACETABULAR SHELL 48 ACETABULAR SHELL MEH MEDACTA INTERNATIONAL SA 01.26.48MB 153606 07630030808036

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention