BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINER: MPACT FLAT PE HC LINER Ø36/E

    MDR report key: 17779522 · Received September 20, 2023

    Report

    Report Number
    3005180920-2023-00719
    Event Type
    Injury
    Date Received
    September 20, 2023
    Date of Event
    August 21, 2023
    Report Date
    September 20, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630030812118
    PMA / PMN Number
    K103721
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 28-AUG-2023 LOT 2247621: 100 ITEMS MANUFACTURED AND RELEASED ON 16-FEB-2023. EXPIRATION DATE: 2028-01-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 68 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. VISUAL INSPECTION PERFORMED BY R&D PROJECT MANAGER: THE CUP AND THE SLEEVE WERE ANALYZED. FROM THE RECEIVED PARTS, NO PARTICULAR SIGNS OF EVIDENCE OF DEVICE FAILURE WERE NOTICED: THE SHELL SHOWED SOME TISSUE IN THE PYRAMIDAL NET AND AN INTERNAL GROOVE DUE TO DAMAGES OCCURRED DURING THE REMOVAL (PROBABLY WITH THE SCREW), WHILE THE SLEEVE DID NOT PRESENT PARTICULAR SIGNS. ADDITIONAL ITEMS INVOLVED IN THE EVENT, BATCH REVIEW PERFORMED ON 28-AUG-2023 BALL HEADS: MECTACER 01.29.232H HEAD BIOLOX OPTION Ø 36 (K131518) LOT. 2248508 LOT 2248508: 20 ITEMS MANUFACTURED AND RELEASED ON 17-JAN-2023. EXPIRATION DATE: 2027-12-18. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 9 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. CUP: MPACT 3D METAL 01.38.352MH ACETABULAR SHELL Ø52 MULTI-HOLE THIN (K202568) LOT. 2007121 LOT 2007121: 52 ITEMS MANUFACTURED AND RELEASED ON 30-OTT-2020. EXPIRATION DATE: 2025-10-21. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 20 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. BALL HEADS: MECTACER 01.29.240A SLEEVE SIZE S (K131518) LOT. 176412B LOT 176412B: 3 ITEMS MANUFACTURED AND RELEASED ON 5-APR-2023. EXPIRATION DATE: 2028-03-18. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 2 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    DURING THE HIP SURGERY, THE TRIAL REDUCTION WAS PERFORMED USING A CUP 52MM, LINER 36MM, AND HEAD 36MM, SLEEVE S. SINCE THERE WAS NO DISLOCATION TENDENCY, THE IMPLANTS OF THE SAME SIZES WERE INSERTED IN THE SAME POSITIONS AS TRIALS. HOWEVER, IT WAS NOTICED THAT THE IMPLANT TENDED TO DISLOCATE. IN ADDITION, CUP FIXATION WAS POOR. THE SURGERY WAS SUCCESSFULLY COMPLETED USING A CUP 54 MM, LINER 36 MM AND HEAD, SLEEVE M.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2060323 LINER: MPACT FLAT PE HC LINER Ø36/E FLAT PE LINER LPH MEDACTA INTERNATIONAL SA 2247621 07630030812118

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Female Required Intervention