BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BMT 360 TIBIAL TRAY 79MM

    MDR report key: 9756930 · Received February 26, 2020

    Report

    Report Number
    0001825034-2020-00869
    Event Type
    Injury
    Date Received
    February 26, 2020
    Report Date
    June 4, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    K093293
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. 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. D11: ITEM 185650, LOT 978700; ITEM 185212, LOT 760120; ITEM 141620, LOT 915560; ITEM 00597206535, LOT 63615079; ITEM 185211, LOT 479690; ITEM 141618, LOT 667930; ITEM 185263, LOT 6611371; ITEM 185423, LOT 157670; ITEM 185483, LOT 856810; ITEM 185463, LOT 157930. THIS COMPLAINT WAS CONFIRMED. VISUAL EXAMINATION OF THE RETURNED LOCKING BAR FOUND COSMETIC DAMAGES SUCH AS NICKS AND GOUGES. DEVICE WAS SUBMITTED FOR FURTHER ANALYSIS. ANALYSIS DETERMINED THE FEATURES OF THE LOCKING BAR SURFACE WEAR PATTERNS ALIGN WITH THE THOSE REPORTED IN SUMMARY OF VISUAL ANALYSIS OF TIBIAL LOCKING BARS, SHOWING CONTACT MARKS THAT APPEAR TO STOP SHORT OF THE LOCKING BAR CLASPS FULLY ENGAGED POSITION AND THE LOCKING BAR CLASPS SHOW LITTLE VISIBLE EVIDENCE THAT THE CLASP HAD LOCKED INTO PLACE AGAINST THE MEDICAL TIBIAL LUG. REVIEW OF THE DEVICE HISTORY RECORD(S) IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. A NEXGEN PATELLA (PART 00597206535) WAS USED WITH THE VANGUARD 360/SSK SYSTEM, WHICH IS NOT A COMPATIBLE COMBINATION. HOWEVER, THIS MOST LIKELY DID NOT CONTRIBUTE TO THE REPORTED EVENT. X-RAYS WERE PROVIDED AND REVIEWED BY A HEALTHCARE PROFESSIONAL. REVIEW FOUND DISASSEMBLY DEMONSTRATED BY REPOSITIONING OF THE LOCKING BAR, RESULTING IN MINIMAL (IF ANY) VALGUS ORIENTATION OF THE KNEE. A DEFINITIVE ROOT CAUSE CANNOT 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 · 0

    IT WAS REPORTED THAT THREE MONTHS AFTER CASE THE PATIENT WAS EXPERIENCING PAIN. AFTER X-RAYS IT WAS REVEALED THAT THE TIBIAL LOCKING BAR HAS COME LOOSE AND WORKED ITS WAY OUT OF THE TIBIAL PLATE AND POLY BEARING AND THE PATIENT WAS REVISED.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    (B)(4). UDI # (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION AS THE PRODUCT REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. CONCOMITANT MEDICAL PRODUCTS: ITEM 183904 LOT 767180, ITEM 3011630001-3 LOT 840EAG1904, ITEM 3011630001-3 LOT 840EAG1904. REPORT SOURCE: (B)(6). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2020-00870.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THREE MONTHS AFTER CASE THE PATIENT WAS EXPERIENCING PAIN. AFTER X-RAYS IT WAS REVEALED THAT THE TIBIAL LOCKING BAR HAS COME LOOSE AND WORKED ITS WAY OUT OF THE TIBIAL PLATE AND POLY BEARING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    221207 BMT 360 TIBIAL TRAY 79MM PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 923590

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R