BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINER: MPACT FLAT PE HC LINER 40/G

    MDR report key: 12148668 · Received July 12, 2021

    Report

    Report Number
    3005180920-2021-00588
    Event Type
    Injury
    Date Received
    July 12, 2021
    Date of Event
    June 22, 2021
    Report Date
    July 12, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030812286
    PMA / PMN Number
    K122641
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 01 JULY 2021: LOT 1900227: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 17-APR-2019. EXPIRATION DATE: 2024-04-06. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH A SIMILAR REPORTED EVENT. ADDITIONAL IMPLANT INVOLVED: BALL HEADS: MECTACER 01.29.213 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 40 SIZE M 0 (K112115) LOT. 1907365. BATCH REVIEW PERFORMED ON 02 JULY 2021: LOT 1907365: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 27-JAN-2020. EXPIRATION DATE: 2025-01-05. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ADDITIONAL IMPLANT INVOLVED: CUP: MPACT 01.32.160DH ACETABULAR SHELL Ø60 TWO-HOLES (K132879) LOT. 1904329. BATCH REVIEW PERFORMED ON 02 JULY 2021: ¨LOT 1904329: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 27-AUG-2019. EXPIRATION DATE: 2024-08-17. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH A SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. ABOUT 11 MONTHS AFTER PRIMARY THE SURGEON PERFORMED A WASHOUT AND REVISED THE CUP, HEAD, AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1046039 LINER: MPACT FLAT PE HC LINER 40/G ACETABULAR PE HC LINER LZO MEDACTA INTERNATIONAL SA 01.32.4052HCT 1900227 07630030812286

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention