BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 10136927 · Received June 10, 2020

    Report

    Report Number
    3005180920-2020-00324
    Event Type
    Injury
    Date Received
    June 10, 2020
    Date of Event
    June 5, 2020
    Report Date
    June 10, 2020
    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 · 1

    BATCH REVIEW PERFORMED BY MEDACTA REGULATORY AFFAIRS DEPARTMENT ON 25 MAY 2020: LOT 1900806: (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 ALREADY SOLD WITH NO OTHER SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    THE PATIENT CAME IN REPORTING INSTABILITY 7 MONTHS AFTER THE PRIMARY SURGERY WHICH WAS CAUSED BY A LEG LENGTH DISCREPANCY. THE PRIMARY SURGERY WAS NOT AMIS. DR. (B)(6) USES ORTHOGRID ON HIS C-ARM FLUOROSCOPY AND FELT THAT THE LENGTH AND OFFSET LOOKED GOOD DURING THE CASE. HE SAID THE POST-OP X-RAYS LOOKED GOOD AS WELL, BUT THE PATIENT EXPERIENCED A "SHORTENED" FEELING OF THE LEG WHEN SHE WAS WEIGHT-BEARING. THE SURGEON REVISED THE HEAD AND IMPLANTED THE OPTION SLEEVE. THE LINER WASN'T REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601781 BALL HEADS: MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 36 SIZE M CERAMIC BALL HEAD LZO MEDACTA INTERNATIONAL SA 01.29.209 1900806 07630030809200

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention