BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINER: MPACT FLAT PE HC LINER Ø36/F

    MDR report key: 9523160 · Received December 27, 2019

    Report

    Report Number
    3005180920-2019-01098
    Event Type
    Injury
    Date Received
    December 27, 2019
    Date of Event
    November 28, 2019
    Report Date
    December 27, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630030812132
    PMA / PMN Number
    K103721
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 12 DECEMBER 2019. LOT 1811218: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 14-MAR-2019. EXPIRATION DATE: 2024-03-03. 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 IMPLANT INVOLVED IN THE EVENT, BATCH REVIEW PERFORMED ON 12 DECEMBER 2019. BALL HEADS: MECTACER 01.29.208 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE S - 4 (K112115) LOT. 1900802. LOT 1900802: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 08-MAY-2019. EXPIRATION DATE: 2024-04-21. 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 · 1

    ONE MONTH AFTER THR, THE PATIENT CAME IN FOR WOUND DEBRIDEMENT DUE TO INFECTION. DURING THE SURGERY, THE FEMORAL HEAD AND THE ACETABULAR LINER HAD REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1322528 LINER: MPACT FLAT PE HC LINER Ø36/F FLAT PE HC LINER LPH MEDACTA INTERNATIONAL SA 1811218 07630030812132

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention