BEUDAMED
    FDA Adverse Event Injury Summary report: N

    32MM COCR BIOMET FEM HD -3 NK

    MDR report key: 7855465 · Received September 7, 2018

    Report

    Report Number
    3002806535-2018-01056
    Event Type
    Injury
    Date Received
    September 7, 2018
    Date of Event
    February 12, 2016
    Report Date
    September 7, 2018
    Manufacturer
    BIOMET UK LTD.
    Product Code
    KWA
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6). THIS PRODUCT IS MANUFACTURED BY ZIMMER BIOMET US AND IS NOT CLEARED OR DISTRIBUTED IN THE U.S. HOWEVER, THIS REPORT IS BEING SUBMITTED AS ZIMMER BIOMET IN (B)(4) MANUFACTURES A SIMILAR DEVICE IN THE UNITED STATES UNDER 510K NUMBER K042037. CONCOMITANT MEDICAL PRODUCTS: 22-301300, ARCOS CON SZ A STD 50MM HA, 633150; 22-300919, ARCOS 19X190MM SPL TPR DIST HA, 729090; EP-105833, EPOLY RLC 32MM 10DEG SZ23, 220060; UNKNOWN HIP SHELL; 350806, 2.0 MM SS CABLE/SLEEVE COMBO, 300410; UNKNOWN CABLE ATTACHMENT. THE COMPLAINT CANNOT BE CONFIRMED AS THE FOLLOW OP NOTES WERE NOT PROVIDED. X-RAYS WERE REVIEWED; OVERALL FIT AND ALIGNMENT OF THE IMPLANTS IS APPROPRIATE. OSTEOPENIA IS PRESENT ON ALL IMAGES. X-RAY DEMONSTRATES LUCENCY ALONG THE PROXIMAL FEMORAL COMPONENT WHICH CAN SUGGEST EARLY LOOSENING. OBLIQUE FRACTURE OF THE PROXIMAL FEMORAL DIAPHYSIS LATERALLY IS ALSO SEEN ON THIS IMAGE WHICH COULD MEAN THE PERIPROSTHETIC FRACTURE SUSTAINED CAUSING THE REVISION NEVER HEALED. THIS, HOWEVER, IS UNCONFIRMED. THE DEVICE HISTORY RECORDS REVIEWED AND IDENTIFIED NO ANOMALIES OR DEVIATIONS. ROOT CAUSE COULD NOT BE DETERMINED WITH INFORMATION AVAILABLE. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 1

    IT WAS REPORTED IN A CLINICAL STUDY THAT A PATIENT UNDERWENT RIGHT HIP REVISION SURGERY FOLLOWING A PERIPROSTHETIC FRACTURE, AND SUBSEQUENTLY, THE PATIENT REPORTED MODERATE PAIN AND INABILITY TO PERFORM USUAL ACTIVITIES AT A FOLLOW UP VISIT APPROXIMATELY TWO YEARS POST OPERATIVELY. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    699135 32MM COCR BIOMET FEM HD -3 NK PROSTHESIS, HIP KWA BIOMET UK LTD. N/A 1806301

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Other