BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BALL HEADS: MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE M

    MDR report key: 14101050 · Received April 13, 2022

    Report

    Report Number
    3005180920-2022-00254
    Event Type
    Injury
    Date Received
    April 13, 2022
    Date of Event
    March 16, 2022
    Report Date
    October 26, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030809200
    PMA / PMN Number
    K112115
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 21 MARCH 2022: LOT 1906932: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 27-JAN-2020. EXPIRATION DATE: 2025-01-18. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT. OTHER DEVICES INVOLVED: BATCH REVIEW PERFORMED ON 21 MARCH 2022: LINER: MPACT DM 01.26.2246MHC DOUBLE MOBILITY HC LINER 22.2/DMC (K092265) LOT 2109544: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 14-SEPT-2021. EXPIRATION DATE: 2026-08-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT. LINER: MPACT 01.32.3844MC DM CONVERTER LINER E/DMC (K131458) LOT 2103188: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 27-APR-2021. EXPIRATION DATE: 2026-04-15. 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 Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 9 OCTOBER 2023: LOT 2006694: 300 ITEMS MANUFACTURED AND RELEASED ON 09-OCT-2020. EXPIRATION DATE: 2025-09-24. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL THE ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH ANOTHER SIMILAR REPORTED EVENT IN THE PERIOD OF REVIEW. LOT 2000181: 121 ITEMS MANUFACTURED AND RELEASED ON 10-MAR-2020. EXPIRATION DATE: 2025-02-19. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL THE ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT IN THE PERIOD OF REVIEW. ON THE 6 OCOTBER 2023 WE HAVE THE CONFIRMATION FROM MEDACTA USA THAT THE PRODUCTS REPORTED IN THE EMDR WERE THE IMPLANTED ONES AND NOT THE EXPLANTED DURING THE REVISION SURGERY OF 16 MARCH 2022. WE KNOW ABOUT THIS MODIFICATION AFTER A SECOND REVISION ON THE PATIENT DONE ON 28TH SEPTEMBER 2023, THAT WILL BE REPORTED WITH MDR 2023-00782 (COMPLAINT 1906-23) .

    Description of Event or Problem · 0

    THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. AT 11 MONTHS FROM THE PRIMARY THE SURGEON PERFORMED A WASHOUT AND REVISED THE HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2564449 BALL HEADS: MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE M HIP FEMORAL HEAD LZO MEDACTA INTERNATIONAL SA 01.25.123 2006694 07630030809200
    2937857 BALL HEADS: MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE M HIP FEMORAL HEAD LZO MEDACTA INTERNATIONAL SA 01.25.123 2006694 07630030809200

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Female Required Intervention