BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUP: VERSAFITCUP ACETABULAR SHELL Ø 48

    MDR report key: 16633975 · Received March 29, 2023

    Report

    Report Number
    3005180920-2023-00194
    Event Type
    Injury
    Date Received
    March 29, 2023
    Date of Event
    March 3, 2023
    Report Date
    March 29, 2023
    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 · 0

    BATCH REVIEW PERFORMED ON 08 MARCH 2023: LOT 081312: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10-OCT-2008. EXPIRATION DATE: 2013-08-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL THE ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT IN THE PERIOD OF REVIEW. ADDITIONAL COMPONENTS INVOLVED: BALL HEADS: MECTACER 38.39.7175.255.00 BIOLOX FORTE CERAMIC BALL HEAD 12/14 Ø 28 SIZE M 0 (USA) (K073337) LOT 081264: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28-APR-2008. EXPIRATION DATE: 2013-03-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT IN THE PERIOD OF REVIEW. LINER: VERSAFITCUP DM 01.26.2848M DOUBLE MOBILITY LINER Ø 48/28 (K083116) LOT 083746: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 04-MAR-2009. EXPIRATION DATE: 2013-12-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT IN THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    THE PATIENT CAME IN REPORTING PAIN AND THE CAUSE IS UNKNOWN. AT ABOUT 13 YEARS AND 11 MONTHS POST PRIMARY THE SURGEON REVISED THE MEDACTA CUP AND LINER WITH A COMPETITOR CUP AND LINER, 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
    953848 CUP: VERSAFITCUP ACETABULAR SHELL Ø 48 HIP ACETABULAR CUP MEH MEDACTA INTERNATIONAL SA 01.26.48MB 081312 07630030808036

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention