BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUP: MPACT ACETABULAR SHELL Ø50 TWO-HOLES

    MDR report key: 13357644 · Received January 26, 2022

    Report

    Report Number
    3005180920-2022-00040
    Event Type
    Injury
    Date Received
    January 26, 2022
    Date of Event
    December 28, 2021
    Report Date
    January 26, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630030810763
    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 BY MEDACTA REGULATORY AFFAIRS DEPARTMENT ON 30.DEC.2021: LOT 1907397: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28-NOV-2019. EXPIRATION DATE: 2024-11-19. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH ONE SIMILAR REPORTED EVENT. ADDITIONAL IMPLANT INVOLVED: LINER: MPACT 01.32.3241HCT FLAT PE HC LINER Ø32/D (K103721) LOT. 1902883. BATCH REVIEW PERFORMED BY MEDACTA REGULATORY AFFAIRS DEPARTMENT ON 30.DEC.2021: LOT 1902883: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 08-MAY-2019. EXPIRATION DATE: 2024-04-23. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH ONE SIMILAR REPORTED EVENT. ADDITIONAL IMPLANT INVOLVED: BALL HEADS: MECTACER 01.29.204 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 32 SIZE S -4 (K112115) LOT. 1907339. BATCH REVIEW PERFORMED BY MEDACTA REGULATORY AFFAIRS DEPARTMENT ON 30.DEC.2021: LOT 1907339: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 8-JAN-2020. EXPIRATION DATE: 2024-12-11. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ADDITIONAL IMPLANT INVOLVED: STEM: MASTERLOC 01.39.203 CEMENTLESS TI COATED LAT STEM SIZE 3 (K160289) LOT. 166778C. BATCH REVIEW PERFORMED BY MEDACTA REGULATORY AFFAIRS DEPARTMENT ON 30.DEC.2021: LOT 166778C: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20-APR-2020. EXPIRATION DATE: 2025-04-07. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT SINCE 2016. ADDITIONAL IMPLANT INVOLVED: SCREWS: MPACT 01.32.6530 CANCELLOUS BONE SCREW, FLAT HEAD Ø 6,5 L 30 (K103721) LOT. 1903942. BATCH REVIEW PERFORMED BY MEDACTA REGULATORY AFFAIRS DEPARTMENT ON 30.DEC.2021: LOT 1903942: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 14-JUN-2019. EXPIRATION DATE: 2024-05-19. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ADDITIONAL IMPLANT INVOLVED: SCREWS: MPACT 01.32.6520 CANCELLOUS BONE SCREW, FLAT HEAD Ø 6,5 L 20 (K103721) LOT. 2002400. BATCH REVIEW PERFORMED BY MEDACTA REGULATORY AFFAIRS DEPARTMENT ON 30.DEC.2021: LOT 2002400: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 04-JUN-2020. EXPIRATION DATE: 2025-05-18. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 0

    THE PATIENT CAME IN 1 YEAR AND 2 MONTHS AFTER THE PRIMARY SURGERY DUE TO SIGNS OF 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
    1034992 CUP: MPACT ACETABULAR SHELL Ø50 TWO-HOLES CEMENTLESS ACETABULAR CUP LPH MEDACTA INTERNATIONAL SA 01.32.150DH 1907397 07630030810763

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Female Required Intervention