BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINER: MPACT HOODED PE HC LINER Ø32/D

    MDR report key: 9222731 · Received October 23, 2019

    Report

    Report Number
    3005180920-2019-00892
    Event Type
    Injury
    Date Received
    October 23, 2019
    Date of Event
    September 24, 2019
    Report Date
    October 23, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630030811869
    PMA / PMN Number
    K132879
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON (B)(6) 2019: LOT 172563: 30 ITEMS MANUFACTURED AND RELEASED ON (B)(6) 2017. EXPIRATION DATE: 2022-10-26. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 21 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. BATCH REVIEWS PERFORMED ON (B)(6) 2019. STEM: QUADRA-H 01.12.20SN CEMENTLESS, HA COATED STD STEM SIZE 0, SHORT NECK (K082792) LOT 189854: 77 ITEMS MANUFACTURED AND RELEASED ON 07-FEB-2019. EXPIRATION DATE: 2024-01-14. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 43 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. BALL HEADS: MECTACER 01.29.204 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 32 SIZE S -4 (K112115) LOT 177687: 237 ITEMS MANUFACTURED AND RELEASED ON 09-APR-2018. EXPIRATION DATE: 2023-03-23. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 220 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED AN I&D AND POLY-SWAP 1 MONTH AND 5 DAYS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1016856 LINER: MPACT HOODED PE HC LINER Ø32/D HIP SHELL LINER LPH MEDACTA INTERNATIONAL SA 172563 07630030811869

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention