BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUP: MPACT 3D METAL ACETABULAR SHELL Ø56 TWO-HOLE

    MDR report key: 18510521 · Received January 15, 2024

    Report

    Report Number
    3005180920-2023-01108
    Event Type
    Injury
    Date Received
    January 15, 2024
    Date of Event
    December 18, 2023
    Report Date
    January 15, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630030812613
    PMA / PMN Number
    K171966
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 28-DEC-2023. LOT 2201524:(B)(4) ITEMS MANUFACTURED AND RELEASED ON 28-FEB-2022. EXPIRATION DATE: 2027-02-15. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 38 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF THE REVIEW. VISUAL INSPECTION PERFORMED BY R&D PROJECT MANAGER: DURING THE ANALYSIS IT IS EVALUATED THAT, LOOKING AT THE STEM BODY AN OPAQUE WHITE FILM IS VISIBLE ON THE PROXIMAL PART OF THE STEM. IT IS NOT POSSIBLE TO IDENTIFY IF THIS FILM IS HA OR BONE RESIDUAL, OR A COMBINED EFFECT. NON-ABSORPTION OF HA FROM THE STEM BODY CAN INDICATE THAT METABOLIC ACTIVITY WASN'T TAKING PLACE AND THAT, PRESUMABLY, NOT ADEQUATE BONE CONTACT WAS ACHIEVED AT THE TIME OF SURGERY. SOME SIGNS OF MINOR DAMAGE AND SCRATCHES ARE PRESENT ON THE NECK OF THE EXPLANTED STEM, WHICH IS LIKELY DUE TO THE REVISION SURGERY AND NOT RELEVANT TO THE REPORTED ISSUE. BASED ON THE ANALYSIS COMPLETED AND INFORMATION AVAILABLE, IT IS NOT POSSIBLE TO IDENTIFY A ROOT CAUSE OF THE STEM FAILURE REPORTED. ADDITIONAL IMPLANTS INVOLVED IN THE EVENT, BATCH REVIEW PERFORMED ON 28-DEC-2023. STEM: AMISTEM-P COLLARED 01.18.444 AMISTEM-P COLLARED LAT STEM SIZE 4 (K173794) LOT. 1811135 LOT 1811135: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 08-APR-2019. EXPIRATION DATE: 2024-03-23. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 13 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW LINER: MPACT 01.32.3648HCT FLAT PE HC LINER 36/F (K103721) LOT. 2114163. LOT 2114163: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26-OCT-2021. EXPIRATION DATE: 2026-10-10. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 140 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW. BALL HEADS: MECTACER 01.29.209 BIOLOX DELTA CERAMIC BALL HEAD 12/14 36 SIZE M 0 (K112115) LOT. 2115385 LOT 2115385: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 27-JAN-2022. EXPIRATION DATE: 2027-01-17. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 168 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF THE REVIEW.

    Description of Event or Problem · 0

    AT ABOUT 1 YEAR AND 6 MONTHS AFTER PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON EXPLANTED THE CUP, LINER, HEAD AND STEM AND PLACED AN ANTIBIOTIC SPACER PER THE 2 STAGE INFECTION PROTOCOL. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    644651 CUP: MPACT 3D METAL ACETABULAR SHELL Ø56 TWO-HOLE CEMENTLESS ACETABULAR CUP LPH MEDACTA INTERNATIONAL SA 2201524 07630030812613

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention