BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 18056339 · Received November 2, 2023

    Report

    Report Number
    3005180920-2023-00798
    Event Type
    Injury
    Date Received
    November 2, 2023
    Date of Event
    October 9, 2023
    Report Date
    November 2, 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 10 OCTOBER 2023. LOT 2206394: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 23-JUNE-2022. EXPIRATION DATE: 2026-06-07. 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. ADDITIONAL IMPLANTS INVOLVED, BATCH REVIEW PERFORMED ON 10 OCTOBER 2023: CUP: MPACT 01.32.152DH ACETABULAR SHELL Ø52 TWO-HOLES (K132879) LOT 2203921: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25-MAY-2022. EXPIRATION DATE: 2027-05-10. 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. LINER: MPACT 01.32.3644HCT FLAT PE HC LINER Ø36/E (K103721) LOT 2202298: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 09-MARCH-2022. EXPIRATION DATE: 2027-02-27. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH ANOTHER SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    AT ABOUT 1 YEAR AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO TA DISLOCATION OF THE HEAD FROM THE LINER AND THE CAUSE IS UNKNOWN. WHEN REVISING THE PATIENT THE SURGEON NOTICED THAT THE CUP HAD NOT ADHERED TO THE BONE IN ONE AREA, SO HE DECIDED TO REVISE THE CUP, HEAD, AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1889568 MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE M HIP BALL HEAD LZO MEDACTA INTERNATIONAL SA 2206394 07630030809200

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Female Required Intervention