BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EPOLY RLC 36MM 10DEG SZ24

    MDR report key: 7352552 · Received March 20, 2018

    Report

    Report Number
    0001825034-2018-02051
    Event Type
    Injury
    Date Received
    March 20, 2018
    Date of Event
    August 13, 2014
    Report Date
    March 20, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    PK070399
    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) MULTIPLE MDR'S WERE SUBMITTED FOR THIS EVENT. PLEASE SEE REPORTS: 0001825034-2018-02048, 0001825034-2018-02049, 0001825034-2018-02050. CONCOMITANT MEDICAL PRODUCTS: 22-301355 ARCOS CON SZ E HI 80 MM HA, LOT 766400. THE 22-300920 ARCOS 20 X 190 MM SPL TPR DIST HA, LOT 530270. PT-106056 REGEN/RNGLC+ MULTI 56 MM SZ 24, LOT 187210. THE 650-0843 36 MM COCR BIOMET FEM HD +6 NK, LOT 3229357. (B)(6). REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. 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. DEVICE REMAINS IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A TOTAL LEFT HIP ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT DEVELOPED A URINARY TRACT INFECTION POST-IMPLANTATION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    198946 EPOLY RLC 36MM 10DEG SZ24 PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 251340

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other