BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINER: MPACT FLAT PE HC LINER Ø36/F

    MDR report key: 17316329 · Received July 13, 2023

    Report

    Report Number
    3005180920-2023-00516
    Event Type
    Injury
    Date Received
    July 13, 2023
    Date of Event
    June 16, 2023
    Report Date
    July 13, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630030812132
    PMA / PMN Number
    K103721
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 04 JULY 2023: LOT 2116165: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 15-DEC-2021. EXPIRATION DATE: 2026-11-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH OTHER 2 SIMILAR REPORTED EVENT IN THE PERIOD OF REVIEW. ADDITIONAL DEVICES INVOLVED, BATCH REVIEW PERFORMED ON 04 JULY 2023: BALL HEADS: MECTACER 01.29.211 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE XL +8 (K112115) LOT 1907363 LOT 1907363: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20-NOV-2019. EXPIRATION DATE: 2024-11-10. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH ANOTHER SIMILAR REPORTED EVENT IN THE PERIOD OF REVIEW. STEM: SMS SOLID 01.36.045 SMS SOLID STEM STD SIZE 5 (K181693) LOT. 2114510 LOT 2114510: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 09-MAR-2022. EXPIRATION DATE: 2027-02-27. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT IN THE PERIOD OF REVIEW. CUP: MPACT 3D METAL 01.38.056DH ACETABULAR SHELL Ø56 TWO-HOLE (K171966) LOT. 2119570. LOT 2119570: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 31-JAN-2022. EXPIRATION DATE: 2027-01-18. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT IN THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    THE PATIENT HAD A PRIMARY HIP SURGERY ON (B)(6) 2022. ON (B)(6) 2022, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE HEAD AND LINER (EMDR 2022-00792). THE SURGERY WAS COMPLETED SUCCESSFULLY. PRESENTLY, ON (B)(6) 2023, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT, REMOVED ALL IMPLANTS, AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313336 LINER: MPACT FLAT PE HC LINER Ø36/F HIP LINER LPH MEDACTA INTERNATIONAL SA 01.32.3648HCT 2116165 07630030812132

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention