BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUP: MPACT ACETABULAR SHELL Ø48 NO-HOLE

    MDR report key: 16094457 · Received January 4, 2023

    Report

    Report Number
    3005180920-2022-00995
    Event Type
    Injury
    Date Received
    January 4, 2023
    Date of Event
    December 20, 2022
    Report Date
    January 4, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630030810756
    PMA / PMN Number
    K132879
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 22 DECEMBER 2022: LOT 2013632: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22-MAR-2021. EXPIRATION DATE: 2026-03-07. 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. ADDITIONAL COMPONENTS INVOLVED IN THE EVENT: BALL HEADS: MECTACER 01.29.206 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 32 SIZE L +4 (K112115) LOT. 2012914: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 09-APR-2021. EXPIRATION DATE: 2026-03-25. 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: MPACT 01.32.3239HCT FLAT PE HC LINER Ø32/C (K103721) LOT. 2108134: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03-AUG-2021. EXPIRATION DATE: 2026-07-19. 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 1 YEAR AND 1 MONTH POST PRIMARY THE SURGEON REVISED THE MEDACTA CUP AND LINER WITH COMPETITOR COMPONENTS 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
    1178278 CUP: MPACT ACETABULAR SHELL Ø48 NO-HOLE HIP ACETABULAR CUP LPH MEDACTA INTERNATIONAL SA 01.32.148SH 2013632 07630030810756

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention