BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET FINNED PRI STEM 40MM

    MDR report key: 18085157 · Received November 7, 2023

    Report

    Report Number
    0001825034-2023-02619
    Event Type
    Injury
    Date Received
    November 7, 2023
    Date of Event
    November 21, 2022
    Report Date
    April 24, 2024
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    UDI-DI
    00880304006706
    PMA / PMN Number
    K171054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. H6: PROPOSED COMPONENT (ANNEX G) CODE IS 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. MEDICAL RECORDS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: X-RAYS REVEAL GOOD FIT OF THE PROSTHESIS, KNEE STABLE WITHOUT EFFUSION, PATIENT TRIPPED BRUISING BOTH KNEES, PATIENT REPORTS HAVING TROUBLE SLEEPING WITH PAIN RADIATING DOWN THE SIDE OF HER KNEE AND USES A CANE FOR AMBULATION, MILDLY REACTIVE TO ALUMINUM, CHROMIUM, IRON AND REACTIVE TO NICKEL, PATIENT INJURED A DISC IN HER SPINE WHEN THEY FELL, KNEE SORENESS WITH STIFFNESS FROM FAVORING ONE SIDE WHILE WALKING, INSTABILITY ON VALGUS VARUS, CLICKING, FLEXION LIMITED TO 90 DEGREES, ARTHROFIBROSIS. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. HOWEVER, THE REPORTED PRODUCT CONTAINS THE ALLEGED ALLERGEN AND COULD BE A POSSIBLE CAUSE. THE COMPLAINT IS CONFIRMED VIA MEDICAL RECORDS. 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.

    Additional Manufacturer Narrative · 0

    (B)(4). D10: MEDICAL PRODUCT: VNGD TI FEM CR 65MM RT: CATALOG#CP113618, LOT#933290; TIBIAL BEARING CRUCIATE RETAINING (CR) 71/75 MM WIDTH 10MM THICKNESS: CATALOG#VE183440, LOT#64396956; BIOMET ILOK PRI TIB TRAY 71MM: CATALOG#141213, LOT#808980; SERIES A PAT STD 31 3 PEG: CATALOG#184764, LOT#539210. MULTIPLE MDR REPORTS HAVE BEEN FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2023-02420; 0001825034-2023-02421; 0001822565-2023-03098;. THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE PRODUCT LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. UPON RECEIPT OF ADDITIONAL INFORMATION OR COMPLETION OF THE INVESTIGATION, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT INITIAL RIGHT TOTAL KNEE ARTHROPLASTY. THE PATIENT DID WELL UNTIL NEARLY A YEAR LATER WHEN THE PATIENT BEGAN TO EXPERIENCE PAIN, INSTABILITY, AUDIBLE CLICKING, AND LIMITED FLEXION DUE TO ARTHROFIBROSIS. METAL ALLERGY TESTING CONFIRMED A REACTIVITY TO NICKEL. THE SURGEON ATTRIBUTED THE PATIENT¿S INSTABILITY TO NICKEL WITHIN THE TITANIUM COMPONENTS. SUBSEQUENTLY, ONE YEAR POST-IMPLANTATION, THE PATIENT UNDERWENT OPEN INCISIONAL BIOPSY FOLLOWED BY RADICAL DEBRIDEMENT AND A REVISION OF ALL TIBIAL AND FEMORAL COMPONENTS. A COMPETITOR SYSTEM WAS IMPLANTED AND THE ORIGINAL PATELLA WAS RETAINED. DUE DILIGENCE IS COMPLETE AS MULTIPLE ATTEMPTS HAVE BEEN MADE; NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    348367 BIOMET FINNED PRI STEM 40MM PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. 343790 00880304006706

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Hospitalization| R SEE H10 NARRATIVE.