BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CER OPT TYPE 1 TPR SLEVE 0MM

    MDR report key: 8673877 · Received June 6, 2019

    Report

    Report Number
    3002806535-2019-00490
    Event Type
    Injury
    Date Received
    June 6, 2019
    Date of Event
    April 18, 2019
    Report Date
    August 28, 2019
    Manufacturer
    BIOMET UK LTD.
    Product Code
    LZO
    UDI-DI
    00880304520158
    PMA / PMN Number
    K141653
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL RIGHT HIP REPLACEMENT PROCEDURE. SUBSEQUENTLY, THE PATIENT WAS TREATED FOR A URINARY TRACT INFECTION 18 DAYS AFTER SURGERY.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: MEDICAL PRODUCT: CER BIOLOXD OPTION HD 36MM , CATALOG #:650-1057, LOT #:2950529. MEDICAL PRODUCT: G7 PPS LTD ACET SHELL 56F , CATALOG #: 010000665, LOT #: 6435946. MEDICAL PRODUCT: G7 NEUTRAL E1 LINER 36MM F, CATALOG #: 010000858, LOT #:6463319. MEDICAL PRODUCT:TPRLC 133 MP TYPE1 PPS HO 16.0 , CATALOG #: 51-107160, LOT #: 6450916. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 3002806535-2019-00489, 0001822565-2019-02267, 0001825034-2019-02371, 0001825034-2019-02374. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. DEVICE EVALUATED BY MANUFACTURER? REMAINS IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL RIGHT HIP REPLACEMENT PROCEDURE. SUBSEQUENTLY, THE PATIENT WAS TREATED FOR A URINARY TRACT INFECTION 18 DAYS AFTER SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    470369 CER OPT TYPE 1 TPR SLEVE 0MM HIP PROSTHESIS LZO BIOMET UK LTD. N/A 2954554 00880304520158

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention