BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINER: MPACT FLAT PE HC 40/G

    MDR report key: 12134401 · Received July 8, 2021

    Report

    Report Number
    3005180920-2021-00552
    Event Type
    Injury
    Date Received
    July 8, 2021
    Date of Event
    June 11, 2021
    Report Date
    July 8, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030812286
    PMA / PMN Number
    K122641
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 22 JUNE 2021: LOT 2009617: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28-OCT-2020. EXPIRATION DATE: 2025-10-18. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANOTHER SIMILAR REPORTED EVENT. OTHER DEVICES INVOLVED: BATCH REVIEW PERFORMED ON 22 JUNE 2021: BALL HEADS: MECTACER 01.29.233H HEAD BIOLOX OPTION Ø 40 (K131518) LOT 176860: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 16-APR-2018. EXPIRATION DATE: 2024-04-02. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT. BALL HEADS: MECTACER 01.29.242A SLEEVE SIZE L (K131518) LOT 19C0072: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 11-DEC-2019. EXPIRATION DATE: 2024-11-27. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT. CUP: MPACT 01.32.160DH ACETABULAR SHELL Ø60 TWO-HOLES (K132879) 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 WITHOUT ANY SIMILAR REPORTED EVENT. STEM: MASTERLOC 01.39.209 CEMENTLESS TI COATED LAT STEM SIZE 9 (K151531)LOT 1908741: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26-FEB-2020. EXPIRATION DATE: 2025-02-09. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    THE PATIENT HAD A PRIMARY HIP SURGERY ON (B)(6) 2021. ON (B)(6) 2021, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN WAS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY. 1 MONTH AFTER PRIMARY ON (B)(6) 2021, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REMOVED ALL COMPONENTS AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1034373 LINER: MPACT FLAT PE HC 40/G ACETABULAR LINER PE HC LZO MEDACTA INTERNATIONAL SA 01.32.4052HCT 2009617 07630030812286

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention