BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUP: MPACT ACETABULAR SHELL Ø54 TWO-HOLES

    MDR report key: 18281395 · Received December 7, 2023

    Report

    Report Number
    3005180920-2023-00960
    Event Type
    Injury
    Date Received
    December 7, 2023
    Date of Event
    November 14, 2023
    Report Date
    February 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

    ADDITIONAL INFORMATION REPORTED IN THIS FOLLOW UP: - EVENT DESCRIPTION UPDATED BECAUSE WE HAVE BEEN INFORMED THAT PERMANENT IMPLANTS WERE PLACED ON (B)(6) 2024. THE NEW DESCRIPTION IS: AT ABOUT 4 YEARS FROM THE PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON EXPLANTED ALL IMPLANTS AND PLACED AN ANTIBIOTIC SPACER FOR A 2-STAGE INFECTION PROTOCOL. THE SURGERY WAS COMPLETED SUCCESSFULLY. ON (B)(6) 2024, PERMANENT IMPLANTS WERE PLACED (ABOUT 4 YEARS AND 2 MONTHS AFTER THE PRIMARY SURGERY).

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 20 NOVEMBER 2023: LOT 1811190: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 21-MAR-2019. EXPIRATION DATE: 2024-03-11. 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 20 NOVEMBER 2023: LINER: MPACT 01.32.3644HCT FLAT PE HC LINER Ø36/E (K103721) LOT. 1903449 LOT 1903449: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 23-MAY-2019. EXPIRATION DATE: 2024-05-08. 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. BALL HEADS: COCR 01.25.031 COCR BALL HEAD 12/14 Ø 36 SIZE M 0 (K080885) LOT. 1902383 LOT 1903234: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 17-JUL-2019. EXPIRATION DATE: 2024-07-07. 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: AMISTEM P 01.18.435 AMISTEM-P COLLARED STD STEM SIZE 5 (K173794) LOT. 1903234 LOT 1902383: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28-AUG-2019. EXPIRATION DATE: 2024-08-18. 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.

    Description of Event or Problem · 0

    AT ABOUT 4 YEARS FROM THE PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON EXPLANTED ALL IMPLANTS AND PLACED AN ANTIBIOTIC SPACER FOR A 2-STAGE INFECTION PROTOCOL. THE SURGERY WAS COMPLETED SUCCESSFULLY. ON (B)(6) 2024, PERMANENT IMPLANTS WERE PLACED (ABOUT 4 YEARS AND 2 MONTHS AFTER THE PRIMARY SURGERY).

    Description of Event or Problem · 0

    AT ABOUT 4 YEARS FROM THE PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON EXPLANTED ALL IMPLANTS AND PLACED AN ANTIBIOTIC SPACER FOR A 2-STAGE INFECTION PROTOCOL. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1086027 CUP: MPACT ACETABULAR SHELL Ø54 TWO-HOLES ACETABULAR SHELL LPH MEDACTA INTERNATIONAL SA 1811190 07630030810824

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention