BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINER: MPACT FLAT PE HC LINER 36/F

    MDR report key: 10459033 · Received August 27, 2020

    Report

    Report Number
    3005180920-2020-00561
    Event Type
    Injury
    Date Received
    August 27, 2020
    Date of Event
    July 29, 2020
    Report Date
    August 27, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630030862663
    PMA / PMN Number
    K103721
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED BY MEDACTA REGULATORY AFFAIRS DEPARTMENT ON 11 AUGUST 2020: LOT 1910290: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 29-JAN-2020. EXPIRATION DATE: 2024-12-15, NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED. ADDITIONAL ITEMS INVOLVED IN THE EVENT, BATCH REVIEW PERFORMED BY MEDACTA REGULATORY AFFAIRS DEPARTMENT ON 11 AUGUST 2020. BALL HEADS: MECTACER 01.29.232H HEAD BIOLOX OPTION Ø 36 (K131518) LOT. 1907391A. LOT 1907391A: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22-NOV-19. EXPIRATION DATE: 2024-11-11, NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED. BALL HEADS: MECTACER 01.29.241A SLEEVE SIZE M (K131518) LOT.1907392. LOT 1907392: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 27-NOV-19. EXPIRATION DATE: 2024-11-12, NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED.

    Description of Event or Problem · 1

    THE PATIENT HAD A REVISION SURGERY DUE TO NOT HEALING OF THE INCISION. 5 DAYS AFTER IT THE PATIENT HAD A SECOND REVISION SURGERY DUE TO INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED AN I&D AND REVISED THE HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE PRIMARY SURGERY WAS 1 MONTH AND 5 DAYS BEFORE THIS LAST REVISION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    924268 LINER: MPACT FLAT PE HC LINER 36/F FLAT PE LINER LPH MEDACTA INTERNATIONAL SA 02.12.0511FR 1910290 07630030862663

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention