BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINER: MPACT HOODED 32/PE HC LINER C

    MDR report key: 10585023 · Received September 25, 2020

    Report

    Report Number
    3005180920-2020-00646
    Event Type
    Injury
    Date Received
    September 25, 2020
    Date of Event
    August 28, 2020
    Report Date
    September 25, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630030811838
    PMA / PMN Number
    K132879
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED BY MEDACTA REGULATORY AFFAIRS DEPARTMENT ON 09.SEP.2020 LOT 185991: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 27-SEP-2018. EXPIRATION DATE: 2023-09-16. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. ADDITIONAL ITEM INVOLVED IN THE EVENT, BATCH REVIEW PERFORMED ON 09 SEPTEMBER 2020. BALL HEADS: MECTACER 01.29.205 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 32 SIZE M 0 (K112115) LOT. 188242. LOT 188242: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22-JAN-2019. EXPIRATION DATE: 2024-01-09. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. STEM: MASTERLOC 01.39.206 CEMENTLESS TI COATED LAT STEM SIZE 6 (K151531) LOT. 184011. LOT 184011: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 02-OCT-2018. EXPIRATION DATE: 2023-09-20. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. CUP: MPACT 01.32.148DH ACETABULAR SHELL Ø48 TWO-HOLES (K1328799) LOT. 187891. LOT 187891: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20-FEB-2019. EXPIRATION DATE: 2024-02-06. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    REVISION SURGERY PERFORMED AFTER 1 YEAR AND 3 MONTHS AFTER THE PREVIOUS REVISION DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REMOVED ALL COMPONENTS AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE PREVIOUS REVISION SURGERY WAS PERFORMED DUE TO INFECTION AS WELL. THE HEAD AND LINER WERE REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1053628 LINER: MPACT HOODED 32/PE HC LINER C HOODED HC PE LINER LPH MEDACTA INTERNATIONAL SA 01.32.3239HCAT 185991 07630030811838

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention