BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUP: MPACT ACETABULAR SHELL Ø54 TWO-HOLES

    MDR report key: 19328373 · Received May 16, 2024

    Report

    Report Number
    3005180920-2024-00306
    Event Type
    Injury
    Date Received
    May 16, 2024
    Date of Event
    April 16, 2024
    Report Date
    May 16, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630030810824
    PMA / PMN Number
    K132879
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 23-APR-2024. LOT 2303387: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 04-JUL-2023. EXPIRATION DATE: 2028-06-18. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ADDITIONAL COMPONENTS REVISED: BALL HEADS: MECTACER 01.29.210 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE L + 4 (K112115) LOT 2317274: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13-JUL-2023. EXPIRATION DATE: 2028-06-24. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. LINER: MPACT 01.32.3644HCT FLAT PE HC LINER Ø36/E (K103721) LOT 2316736: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 08-AUG-2023. EXPIRATION DATE: 2028-07-23. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. STEM: SMS SOLID 01.36.048 SMS SOLID STEM STD SIZE 8 (K1816939 LOT 2219011: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 17-JAN-2023. EXPIRATION DATE: 2027-12-27. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL THE ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    AT ABOUT 4 MONTHS AFTER PRIMARY, 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
    648753 CUP: MPACT ACETABULAR SHELL Ø54 TWO-HOLES HIP ACETABULAR CUP LPH MEDACTA INTERNATIONAL SA 2303387 07630030810824

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention