BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VNGD CR TIB BRG 10X79/83

    MDR report key: 14675759 · Received June 13, 2022

    Report

    Report Number
    0001825034-2022-01390
    Event Type
    Injury
    Date Received
    June 13, 2022
    Date of Event
    January 9, 2017
    Report Date
    October 10, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    K113550
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). PATIENT YEAR OF BIRTH: (B)(6). CONCOMITANT MEDICAL PRODUCTS: 4710500394-3,141AAL1212 OPTIPAC 40 REFOB BONE CMT R-3. 183032 VANGUARD CR ILOK FEM-LT 70. 141255TNBN, 20120100 TNBN POL COCR FIN TIB TRAY 79. 4710500394, 141AAL1212 OPTIPAC 40 REFOBACIN BN CMT R. REPORT SOURCE: GERMANY. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION DUE TO THE DEVICE WAS DISCARDED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED AS NO PRODUCT WAS RETURNED NOR WERE PICTURES PROVIDED. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELATED TO THE REPORTED EVENT WERE FOUND. MEDICAL RECORDS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THAT THE PATIENT EXPERIENCED INSTABILITY AND PATELLOFEMORAL PAIN. PATELLA WAS RESURFACED AND BEARING WAS REPLACED. NO COMPLICATION WAS NOTED. ROOT CAUSE WAS UNABLE TO BE DETERMINED. PER PACKAGE INSERT, PAIN AND INSTABILITY ARE KNOWN ADVERSE EFFECTS OF THE SYSTEM. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PATIENT UNDERWENT INITIAL KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT WAS REVISED APPROXIMATELY 5 (FIVE) YEARS POST IMPLANTATION DUE TO PAINT AND IMPLANT INSTABILITY. DUE DILIGENCE IS COMPLETE AS MULTIPLE ATTEMPTS WERE MADE; HOWEVER, NO FURTHER INFORMATION IS AVAILABLE. AS NO ADDITIONAL INFORMATION IS AVAILABLE, WE ARE UNABLE TO PROVIDE FURTHER INFORMATION.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AT TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1365580 VNGD CR TIB BRG 10X79/83 PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 617270

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Female Hospitalization| R SEE H10 NARRATIVE.