BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINER: MPACT FLAT PE HC LINER 36/E

    MDR report key: 11875877 · Received May 25, 2021

    Report

    Report Number
    3005180920-2021-00416
    Event Type
    Injury
    Date Received
    May 25, 2021
    Date of Event
    April 26, 2021
    Report Date
    May 25, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630030812118
    PMA / PMN Number
    K103721
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 07 MAY 2021: LOT 2009611: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 29-OCT-2020. EXPIRATION DATE: 2025-10-14. 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: STEM: MASTERLOC 01.39.208 CEMENTLESS TI COATED LAT STEM SIZE 8 (K151531) LOT. 2006740. BATCH REVIEW PERFORMED ON 07 MAY 2021: LOT 2006740: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 15-OCT-2020. EXPIRATION DATE: 2025-10-01. 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: BALL HEADS: COCR 01.25.030 COCR BALL HEAD 12/14 Ø 36 SIZE S -3.5 (K080885) LOT. 133983B. BATCH REVIEW PERFORMED ON 07 MAY 2021: LOT 133983B: (B)(4) ITEM MANUFACTURED AND RELEASED ON 20-NOV-2019. EXPIRATION DATE: 2024-11-06. NO ANOMALIES FOUND RELATED TO THE PROBLEM.

    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 REPORTING PAIN DUE TO A PERIPROSTHETIC FRACTURE THAT WAS CAUSED FROM FALLING. THE SURGEON CABLED THE FRACTURE AND REVISED THE 36MM BIOLOX DELTA HEAD M WITH A 36MM COCR HEAD S. THE SURGERY WAS COMPLETED SUCCESSFULLY. ON (B)(6) 2021, 11 DAYS AFTER PRECEDENT SURGERY, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE STEM, HEAD, AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    771700 LINER: MPACT FLAT PE HC LINER 36/E ACETABULAR PE HC LINER LPH MEDACTA INTERNATIONAL SA 01.32.3644HCT 2009611 07630030812118

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention