BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOLOX DELTA MODULAR CERAMIC HEAD SZ 28MM

    MDR report key: 6208705 · Received December 28, 2016

    Report

    Report Number
    3002806535-2016-00920
    Event Type
    Injury
    Date Received
    December 28, 2016
    Date of Event
    October 2, 2014
    Report Date
    December 27, 2016
    Manufacturer
    BIOMET UK LTD.
    Product Code
    LZO
    PMA / PMN Number
    PK051411
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW UP REPORT IS BEING FILED TO RELAY ADDITIONAL AND CORRECTED INFORMATION. THIS REPORT IS 2 OF 2 MDRS FILED FOR THIS PATIENT (REFERENCE 3002806535-2016-00831 & 00920).

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. CONCOMITANT PRODUCTS: 103200 LOT 063580 TAPERLOC FEMORAL, 123748RF-X LOT 4AN2914775 EXCEED ABT STANDARD SHELL, 650-0790 LOT 3373475 BIOLOX DELTA INSERT.

    Description of Event or Problem · 1

    A PATIENT ENROLLED IN A CLINICAL STUDY EXPERIENCED A TROCHANTER FRACTURE DURING INITIAL TOTAL HIP ARTHROPLASTY. AT 6 MONTH FOLLOW UP, THE PATIENT REPORTED PAIN IN THE HIP AND THIGH, WHICH HAS BEEN ATTRIBUTED TO NON-UNION OF THE FRACTURE.

    Description of Event or Problem · 1

    PATIENT ENROLLED IN A CLINICAL STUDY RECEIVED AN ULTRASOUND GUIDED LOCAL ANAESTHETIC INJECTION APPROXIMATELY 6 MONTHS POST-IMPLANTATION DUE TO LEFT HIP AND GROIN PAIN AND NON-UNION OF TROCHANTER FRACTURE. NO REVISION HAS BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    859505 BIOLOX DELTA MODULAR CERAMIC HEAD SZ 28MM PROSTHESIS, HIP LZO BIOMET UK LTD. N/A 3177796

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention