BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINER: MPACT FLAT PE HC LINER Ø36/F

    MDR report key: 9652060 · Received January 31, 2020

    Report

    Report Number
    3005180920-2020-00021
    Event Type
    Injury
    Date Received
    January 31, 2020
    Date of Event
    January 7, 2020
    Report Date
    January 31, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630030812132
    PMA / PMN Number
    K103721
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 09 JANUARY 2020. LOT 188510: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 27-NOV-2018. EXPIRATION DATE: 2023-11-14. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITH ONE SIMILAR EVENT REPORTED. ADDITIONAL IMPLANT INVOLVED: STEM: MASTERLOC 01.39.009 CEMENTLESS TI COATED STD STEM SIZE 9 (K151531) LOT. 164830. BATCH REVIEW PERFORMED ON 09 JANUARY 2020. LOT 164830: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 19-SEP-2016. EXPIRATION DATE: 2021-09-07. 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: CUP: IMPACT 01.32.156DH ACETABULAR SHELL Ø56 TWO-HOLES (K132879) LOT. 186865. BATCH REVIEW PERFORMED ON 09 JANUARY 2020. LOT 186865: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 16-JAN-2019. EXPIRATION DATE: 2023-12-26. 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: SCREWS: IMPACT 01.32.6530 CANCELLOUS BONE SCREW, FLAT HEAD Ø 6,5 L 30 (K103721) LOT. 1902135. BATCH REVIEW PERFORMED ON 09 JANUARY 2020. LOT 1902135: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 02-APR-2019. EXPIRATION DATE: 2024-03-19. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITH ONE SIMILAR EVENT REPORTED. ADDITIONAL IMPLANT INVOLVED: BALL HEADS: MECTACER 01.29.209 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE M 0 (K112115) LOT. 1900805. BATCH REVIEW PERFORMED ON 09 JANUARY 2020. LOT 1900805:(B)(4) ITEMS MANUFACTURED AND RELEASED ON 08-MAY-2019. EXPIRATION DATE: 2024-04-22. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITH ONE SIMILAR EVENT REPORTED.

    Description of Event or Problem · 1

    THE PATIENT CAME IN, MORE THAN 4 MONTHS AFTER PRIMARY SURGERY, DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REMOVED ALL IMPLANTS AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    117823 LINER: MPACT FLAT PE HC LINER Ø36/F ACETABULAR LINER LPH MEDACTA INTERNATIONAL SA 01.32.3648HCT 188510 07630030812132

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention