BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PAT RMR BLD W/PILOT HLE

    MDR report key: 8750413 · Received July 1, 2019

    Report

    Report Number
    0001822565-2019-02770
    Event Type
    Malfunction
    Date Received
    July 1, 2019
    Date of Event
    June 4, 2019
    Report Date
    December 19, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    HTO
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS NOT CONFIRMED. VISUAL EXAMINATION OF THE RETURNED PRODUCT IDENTIFIED NO SIGN OF USE. INSTRUMENT PASSES BOTH FUNCTIONAL TESTS AND DIMENSIONAL ANALYSIS. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. A SUMMARY OF THE INVESTIGATION HAS BEEN SENT TO THE COMPLAINANT. 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

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: PATELLA REAMER BLADE; P/N: 00597909541, L/N: 64018812, PAT RMR BLD; P/N: 00597909546, L/N: 64270358. REPORT SOURCE: (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001822565 - 2019 - 02769, 0001822565 - 2019 - 02770.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING SURGERY THAT AN INSTRUMENT WILL NOT MATE WITH COMPATIBLE INSTRUMENT AS EXPECTED DURING USE. SUBSEQUENTLY, THE SURGERY WAS COMPLETED WITH A DIFFERENT INSTRUMENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    543292 PAT RMR BLD W/PILOT HLE KNEE INSTRUMENT HTO ZIMMER BIOMET, INC. N/A 64270358

    Patients

    Seq Age Sex Outcome Treatment
    1