BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCOS HA MODULAR REVISION SYSTEM CONE PROXIMAL BODY

    MDR report key: 7854754 · Received September 7, 2018

    Report

    Report Number
    0001825034-2018-01363
    Event Type
    Injury
    Date Received
    September 7, 2018
    Date of Event
    February 12, 2016
    Report Date
    September 7, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWY
    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

    ZIMMER BIOMET COMPLAINT (B)(4). MEDICAL DEVICES: 650-0871 32MM COCR BIOMET FEM HD -3 NK 1806301; 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. FOREIGN- (B)(4). THIS PRODUCT IS NOT CLEARED FOR DISTRIBUTION IN THE U.S. HOWEVER, THIS REPORT IS BEING SUBMITTED AS A SIMILAR DEVICE IS CLEARED FOR DISTRIBUTION UNDER 510K NUMBER K090757 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2018 - 01364, 0001825034 - 2018 - 01366, 0001825034 - 2018 - 01367, 0001825034 - 2018 - 08730, 0001825034 - 2018 - 08732.

    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
    699092 ARCOS HA MODULAR REVISION SYSTEM CONE PROXIMAL BODY PROSTHESIS, HIP KWY ZIMMER BIOMET, INC. N/A 633150

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Other