BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET MAXIM FEMORAL COMPONENT

    MDR report key: 7605493 · Received June 15, 2018

    Report

    Report Number
    0001825034-2018-03976
    Event Type
    Injury
    Date Received
    June 15, 2018
    Date of Event
    May 14, 2018
    Report Date
    July 5, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    PK915132
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS- VANGUARD STABILIZED BEARING 18X75, CATALOG # 189088, LOT # 335000, BIOMET TIBIAL LOCKING BAR: CATALOG # 141205, LOT # 598670, BIOMET CC CRUCIATE TIBIAL TRAY, CATALOG # 141233, LOT # 955820, BIOMET AP PATELLA, CATALOG # 11-150828, LOT # 991210. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION DUE TO THE DEVICE BEING DISCARDED. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2018-03974, 0001825034-2018-03975.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY CORRECTED AND ADDITIONAL INFORMATION. REPORTED EVENT WAS CONFIRMED BY REVIEW OF PRE-REVISION X-RAYS. REVIEW OF X-RAYS INDICATES LOOSENING OF BOTH THE TIBIA AND FEMORAL COMPONENTS. ALSO THE PROMINENT SOFT TISSUE SWELLING AND WIRE INFERIOR TO THE PATELLA. DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. 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 · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A RIGHT KNEE ARTHROPLASTY FIVE YEARS AGO. THE PATIENT HAS BEEN REVISED DUE TO INSTABILITY AND LOOSENING. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    449473 BIOMET MAXIM FEMORAL COMPONENT PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. NI 027780

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization| R