BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINER: MPACT FLAT PE HC LINER Ø36/G

    MDR report key: 8766615 · Received July 8, 2019

    Report

    Report Number
    3005180920-2019-00550
    Event Type
    Injury
    Date Received
    July 8, 2019
    Date of Event
    June 8, 2019
    Report Date
    July 8, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630030812156
    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 08 JULY 2019: LOT 180654: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 29-MAY-2018. EXPIRATION DATE: 2023-05-13. 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 DEVICE INVOLVED, BATCH REVIEW PERFORMED ON 08 JULY 2019 BALL HEADS: MECTACER 01.29.210 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE L + 4 (K112115) LOT 187090: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 19-DEC-2018. EXPIRATION DATE: 2023-12-06. 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

    THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION ABOUT 1 MONTH AFTER PRIMARY, THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    561335 LINER: MPACT FLAT PE HC LINER Ø36/G HIP SHELL INSERT LPH MEDACTA INTERNATIONAL SA 180654 07630030812156

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention