BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUP: MPACT ACETABULAR SHELL Ø56 NO-HOLE

    MDR report key: 15028626 · Received July 15, 2022

    Report

    Report Number
    3005180920-2022-00531
    Event Type
    Injury
    Date Received
    July 15, 2022
    Date of Event
    June 20, 2022
    Report Date
    July 15, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630030810886
    PMA / PMN Number
    K132879
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON (B)(6) 2022. LOT 2115967: 48 ITEMS MANUFACTURED AND RELEASED ON (B)(6) 2022. EXPIRATION DATE: 2027-01-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 22 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW. LOT 2116165: 180 ITEMS MANUFACTURED AND RELEASED ON (B)(6) 2021. EXPIRATION DATE: 2026-11-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 84 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW. LOT 2114373: 159 ITEMS MANUFACTURED AND RELEASED ON (B)(6) 2022. EXPIRATION DATE: 2026-12-21. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 82 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW. LOT 2010025: 40 ITEMS MANUFACTURED AND RELEASED ON (B)(6) 2021. EXPIRATION DATE: 2025-12-14. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 8 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    AT ABOUT 1 MONTH AFTER THE PRIMARY SURGERY, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A SUPERFICIAL INCISION AND DRAINAGE AND NO IMPLANTS WERE REVISED. THE CASE WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1047693 CUP: MPACT ACETABULAR SHELL Ø56 NO-HOLE HIP ACETABULAR CUP CEMENTLESS LPH MEDACTA INTERNATIONAL SA 01.32.156SH 2115967 07630030810886

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Male Required Intervention