BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MPACT ACETABULAR SHELL Ø50 TWO-HOLES

    MDR report key: 13356854 · Received January 26, 2022

    Report

    Report Number
    3005180920-2022-00039
    Event Type
    Injury
    Date Received
    January 26, 2022
    Date of Event
    December 28, 2021
    Report Date
    January 26, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630030810763
    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 21 JANUARY 2022: LOT 2104109: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 07-JUN-2021. EXPIRATION DATE: 2026-05-19. 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. ADDITIONAL DEVICES INVOLVED. BATCH REVIEWS PERFORMED ON 21 JANUARY 2022. LINER: MPACT 01.32.3241HCT FLAT PE HC LINER Ø32/D (K103721) LOT 2006532: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25-AUG-2020. EXPIRATION DATE: 2025-08-17. 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: MECTACER 01.29.205 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 32 SIZE M 0 (K112115) LOT 2012913: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12-APR-2021. EXPIRATION DATE: 2026-03-26. 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: AMISTEM-P COLLARED 01.18.431 AMISTEM-P COLLARED STD STEM SIZE 1 (K173794) LOT 2011561: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 01-FEB-2021. EXPIRATION DATE: 2026-01-20. 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 · 0

    THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE CUP, LINER HEAD, AND STEM ALMOST 2 MONTHS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    936125 MPACT ACETABULAR SHELL Ø50 TWO-HOLES HIP CEMENTLESS SHELL LPH MEDACTA INTERNATIONAL SA 01.32.150DH 2104109 07630030810763

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Female Required Intervention