BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUP: MPACT ACETABULAR SHELL Ø58 TWO-HOLES

    MDR report key: 18299556 · Received December 11, 2023

    Report

    Report Number
    3005180920-2023-01034
    Event Type
    Injury
    Date Received
    December 11, 2023
    Date of Event
    November 17, 2023
    Report Date
    February 15, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630030810893
    PMA / PMN Number
    K132879
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2024, PERMANENT IMPLANTS HAVE BEEN PLACED. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 24 NOVEMBER 2023. LOT 166611: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 01-FEB-2017. EXPIRATION DATE: 2022-JAN-22. 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 ITEMS INVOLVED IN THE COMPLAINTS, BATCH REVIEW PERFORMED ON 24 NOVEMBER 2023: LINER: MPACT 01.32.3648HCT FLAT PE HC LINER Ø36/F (K103721) LOT. 171741. LOT 171741: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 27-SEP-2017. EXPIRATION DATE: 2022-SEP-03. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. BALL HEADS: MECTACER 01.29.210 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE L + 4 (K112115) LOT. 172272. LOT 172272: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 31-JUL-2017. EXPIRATION DATE: 2022-SEP-03. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. STEM: MASTERLOC 01.39.208 CEMENTLESS TI COATED LAT STEM SIZE 8 (K151531) LOT. 171332. LOT 171332: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 04-OCT-2017. EXPIRATION DATE: 2022-SEP-24. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. ABOUT 5 YEARS AND 4 MONTHS AFTER THE PRIMARY SURGERY, THE SURGEON REMOVED ALL IMPLANTS AND PLACED AN ANTIBIOTIC SPACER PER THE 2-STAGE INFECTION PROTOCOL. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2179878 CUP: MPACT ACETABULAR SHELL Ø58 TWO-HOLES ACETABULAR SHELL LPH MEDACTA INTERNATIONAL SA 166611 07630030810893

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention