BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD LIPPED TIBIAL BEARING

    MDR report key: 6816748 · Received August 24, 2017

    Report

    Report Number
    0001825034-2017-06761
    Event Type
    Injury
    Date Received
    August 24, 2017
    Date of Event
    October 16, 2015
    Report Date
    October 10, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    PK113550
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS CONFIRMED BY REVIEW OF THE PROVIDED RADIOLOGY NOTES AND MEDICAL RECORDS. REVIEW OF THE DEVICE HISTORY RECORD IDENTIFIED NO DEVIATIONS OR ANOMALIES. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO WERE TRENDS IDENTIFIED. REVIEW OF RADIOLOGY REPORTS INDICATED THAT THE LEFT KNEE COMPONENTS WERE IMPLANTED WITH THE CORRECT FIT AND ORIENTATION. REVIEW OF MEDICAL RECORDS NOTED THAT PATIENT WAS EXPERIENCING PAIN. WITHOUT THE OPPORTUNITY TO EXAMINE THE COMPLAINT PRODUCT, THE 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.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCT: BIOMET FINNED PRI STEM 40 MM, CAT#: 141314 LOT#: 772460. BMET REGENX PRI TIB TRAY 79 MM, CAT#: 141275 LOT#: 001530. RGX 3 PEG SER A PATELLA 37 MM, CAT#: 141358 LOT#: 550140. VANGUARD CR POR FMRL-LT 72.5, CAT#: 183073 LOT#: 496070. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS IT REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. 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 SUFFERS FROM PAIN, SWELLING, RECURRING EFFUSION AND LAXITY OF THE KNEE. IT WAS FURTHER REPORTED THAT THE PATIENT WEARS A BRACE WHEN EXTENDED WALKING IS PERFORMED. ALSO THERE IS AN AUDIBLE NOISE AND TIGHTNESS NOTED. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT SUFFERS FROM PAIN, RECURRING EFFUSION AND LAXITY OF THE KNEE. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    597692 VANGUARD LIPPED TIBIAL BEARING PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS N/A 634870

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other