BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET FINNED PRI STEM 40MM

    MDR report key: 16794886 · Received April 24, 2023

    Report

    Report Number
    0001825034-2023-00848
    Event Type
    Injury
    Date Received
    April 24, 2023
    Date of Event
    February 20, 2023
    Report Date
    June 12, 2023
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    UDI-DI
    00880304006706
    PMA / PMN Number
    K171054
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). CONCOMITANT MEDICAL PRODUCT: 141263 BIOMET POR PRI TIB TRAY 71MM - 021030. UNKNOWN FEMORAL COMPONENT. UNKNOWN ARTICULAR SURFACE. 184764 SERIES A PAT STD 31 3 PEG - 127140. REPORT SOURCE: FOREIGN COUNTRY: FRANCE. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. 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: 0001825034-2023-00849. 0001825034-2023-00850.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4; B5; D2; G1; G3; G6; H1; H2; H3; H6 H6 : MECHANICAL (G04) - STEM NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. THE DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. REVIEW OF COMPLAINT HISTORY FOUND NO ADDITIONAL RELATED ISSUES FOR THIS ITEM AND THE REPORTED PART AND LOT COMBINATION. MEDICAL RECORDS WERE NOT PROVIDED. AS IT IS UNKNOWN WHAT METAL HAS CAUSED THE POSITIVE TEST RESULT, A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT PRESENTED WITH CHRONIC PAIN THE FOLLOWING YEAR AND HAD AN ALLERGY TEST PERFORMED WHICH TESTED POSITIVE FOR METAL. THE PATIENT WAS THEN REVISED APPROXIMATELY ONE YEAR LATER AND WAS REVISED TO AN ANTI-ALLERGIC PROSTHESIS. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1935641 BIOMET FINNED PRI STEM 40MM PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 000580 00880304006706

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention| H SEE H10.