BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OXF UNI PH3 FEMORAL IMPACTOR

    MDR report key: 8027324 · Received November 1, 2018

    Report

    Report Number
    3002806535-2018-01170
    Event Type
    Malfunction
    Date Received
    November 1, 2018
    Date of Event
    October 2, 2018
    Report Date
    September 4, 2019
    Manufacturer
    BIOMET UK LTD.
    Product Code
    HWA
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY CORRECTED INFORMATION. VISUAL INSPECTION CONFIRMED THE REPORTED EVENT. THE MOST LIKELY CAUSE OF THE REPORTED EVENT WAS THE WEAR AND TEAR OF THE INSTRUMENT. HOWEVER, THE EXACT ROOT CAUSE COULD NOT BE ESTABLISHED. 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.

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, D11, G4, G7, H1, H2, H3, H6, H10. VISUAL INSPECTION CONFIRMED THE REPORTED EVENT. THE INSTRUMENT LOT ZB170901 WAS IN THE FIELD FOR APPROXIMATELY 1 YEAR AND 6 MONTHS. THE MOST LIKELY CAUSE OF THE REPORTED EVENT WAS THE WEAR AND TEAR OF THE INSTRUMENT. 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 SMALL FRAGMENTS ARE DETACHING FORM BOTH THE TIPS OF THE FEMORAL IMPACTORS. NO HARM TO PATIENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SMALL FRAGMENTS ARE DETACHING FORM BOTH THE TIPS OF THE FEMORAL IMPACTORS. NO HARM TO PATIENT.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: OXF UNI PH3 FEMORAL IMPACTOR, ITEM 32-420127, LOT ZB 161203. REPORT SOURCE, FOREIGN - EVENT OCCURRED IN (B)(6). THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORT WERE FILED FOR THIS EVENT; PLEASE SEE ASSOCIATED REPORTS: 3002806535-2018-01171.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SMALL FRAGMENTS ARE DETACHING "FORM" BOTH THE TIPS OF THE FEMORAL IMPACTORS. NO HARM TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    868065 OXF UNI PH3 FEMORAL IMPACTOR BMET GENERAL KNEE INSTRUMENTS HWA BIOMET UK LTD. ZB170901

    Patients

    Seq Age Sex Outcome Treatment
    1 SEE H10