BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUP: MPACT ACETABULAR SHELL Ø52 TWO-HOLES

    MDR report key: 13947494 · Received March 30, 2022

    Report

    Report Number
    3005180920-2022-00205
    Event Type
    Injury
    Date Received
    March 30, 2022
    Date of Event
    March 1, 2022
    Report Date
    March 30, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630030810794
    PMA / PMN Number
    K132879
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 04-MAR-2022: LOT 1903421: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 29-JUL-2019. EXPIRATION DATE: 2024-07-15. NO ANOMALIES WERE FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT OTHER SIMILAR REPORTED EVENTS. ADDITIONAL IMPLANT INVOLVED: LINER: MECTACER 01.29.413 CERAMIC LINER Ø 36 / E (NOT REGISTERED IN USA) LOT. 1903875: BATCH REVIEW PERFORMED ON 04-MAR-2022: LOT 1903875: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26-JUL-2019. EXPIRATION DATE: 2024-07-14. NO ANOMALIES WERE FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITH ANOTHER SIMILAR REPORTED EVENT. ADDITIONAL IMPLANT INVOLVED: STEM: QUADRA-H 01.12.033 CEMENTLESS, HA COATED LAT STEM SIZE 3 (K082792) LOT. 187837: BATCH REVIEW PERFORMED ON 04-MAR-2022: LOT 187837: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06-FEB-2019. EXPIRATION DATE: 2024-01-07. NO ANOMALIES WERE FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT OTHER SIMILAR REPORTED EVENTS. ADDITIONAL IMPLANT INVOLVED: BALL HEADS: MECTACER 01.29.208 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE S - 4 (K112115) LOT. 1902999: BATCH REVIEW PERFORMED ON 04-MAR-2022: LOT 1902999: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12-JUL-2019. EXPIRATION DATE: 2024-06-29. NO ANOMALIES WERE FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT OTHER SIMILAR REPORTED EVENTS. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DEPARTMENT: LATE INFECTION IN CEMENTLESS THA, 2 YEARS AFTER PRIMARY OPERATION IN A (B)(6) YEAR OLD PATIENT. PATIENT REPORTED PAIN AND INSTABILITY IN THE ARTICULATION. RADIOGRAPHIC IMAGES PROVIDED, SHOW CYST FORMATION IN THE LATERAL DYAPHISIS WHICH MAY BE CAUSED BY THE INFECTION. ALL IMPLANTS WERE REMOVED AND A SPACER WAS INSERTED. INFECTION IS A KNOWN POSSIBLE ADVERSE EVENT FOLLOWING EVERY SURGERY, INCLUDING THA'S. TO DATE, THERE IS NO REASON TO SUSPECT THAT THE CAUSE MAY BE LINKED TO THE IMPLANTED DEVICES.

    Description of Event or Problem · 0

    REVISION SURGERY WAS PERFORMED DUE TO CYST FORMATION AND LOOSENING OF THE FEMORAL COMPONENT, SECONDARY TO INFECTION. THE FIRST STAGE REVISION WAS COMPLETED ALMOST 2 YEARS AND 4 MONTHS AFTER PRIMARY, ALL COMPONENTS WERE REMOVED AND THE CEMENT SPACER WAS INSERTED. STAGE TWO IS TO BE COMPLETED AT A LATER STAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    783568 CUP: MPACT ACETABULAR SHELL Ø52 TWO-HOLES CEMENTLESS ACETABULAR CUP LPH MEDACTA INTERNATIONAL SA 01.32.152DH 1903421 07630030810794

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Female Required Intervention