BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BALL HEADS: MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 40 SIZE M

    MDR report key: 18381849 · Received December 22, 2023

    Report

    Report Number
    3005180920-2023-01064
    Event Type
    Injury
    Date Received
    December 22, 2023
    Date of Event
    December 7, 2023
    Report Date
    December 22, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030809248
    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 20 DECEMBER 2023. LOT 2108591: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05-OCT-2021. EXPIRATION DATE: 2026-09-12. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ADDITIONAL COMPONENT INVOLVED: LINER: MPACT 01.32.4052HCT FLAT PE HC LINER Ø40/G (K122641) LOT 2304473: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 29-MARCH-2023. EXPIRATION DATE: 2028-03-07. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    AFTER THE PRIMARY HIP SURGERY, IN POST-OP RECOVERY, JOINT LUXATION OCCURRED. THE SAME DAY OF THE PRIMARY SURGERY, THE SURGEON REVISED HEAD (Ø 40 M TO Ø 40 L) AND UPSIZED THE STEM (SIZE 10 TO SIZE 11) TO SIT PROUD AND COMPENSATE FOR LACK OF TENSION. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    278100 BALL HEADS: MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 40 SIZE M HIP FEMORAL HEAD LZO MEDACTA INTERNATIONAL SA 2108591 07630030809248

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention