BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VNGD CR LIP TIB BRG 10X63/67

    MDR report key: 6947332 · Received October 13, 2017

    Report

    Report Number
    0001825034-2017-08353
    Event Type
    Injury
    Date Received
    October 13, 2017
    Date of Event
    September 20, 2017
    Report Date
    November 29, 2017
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    PK113550
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. CONCOMITANT MEDICAL PRODUCTS: BIOMET ILOK PRI TIB TRAY 67 MM CATALOG #: 141212 LOT #: 144960, 2ND ASST DISP KNEE POSITIONER CATALOG #: 740026 LOT #: 25270, COBALT HV BONE CEMENT 40G CATALOG #: 402282 LOT #: 192260, SERIES A PAT STD 31 3 PEG CATALOG #: 184764 LOT #: 255870, BIOMET FINNED PRI STEM 40 MM CATALOG #: 141314 LOT #: 276560, VANGUARD CR POR FEM-RT 67.5 CATALOG #: 183050 LOT #: 453680.

    Additional Manufacturer Narrative · 1

    REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO TRENDS WERE IDENTIFIED. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. 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 PRODUCTS: UNKNOWN VANGUARD TIBIAL TRAY, CAT#: UNKNOWN LOT#: UNKNOWN. 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. 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: 0001825034-2017-08352, 0001825034-2017-08353. REMAINS IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT UNDERWENT A RIGHT TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT UNDERWENT A REVISION PROCEDURE APPROXIMATELY NINE YEARS POST-IMPLANTATION DUE TO INSTABILITY. THE POLYETHYLENE BEARING AND TIBIAL LOCKING BAR WERE REMOVED AND REPLACED. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT IS BEING CONSIDERED FOR A REVISION SURGERY ON AN UNKNOWN DATE FOR AN UNKNOWN REASON. NO PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    727451 VNGD CR LIP TIB BRG 10X63/67 PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 189900

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other