BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD COMPLETE KNEE SYSTEM - CR TIBIAL BEARING 10X79/83

    MDR report key: 6573444 · Received May 17, 2017

    Report

    Report Number
    0001825034-2017-03322
    Event Type
    Injury
    Date Received
    May 17, 2017
    Date of Event
    December 27, 2016
    Report Date
    November 17, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    PK113550
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. ADVERSE EVENT ONLY; THIS DEVICE DID NOT MALFUNCTION IN THE EVENT.

    Additional Manufacturer Narrative · 1

    MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2017-03323. REPORTED EVENT WAS UNABLE TO BE CONFIRMED AS PART NUMBER / LOT NUMBER OF DEVICE INVOLVED IN THE INCIDENT IS UNKNOWN. DHR REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. 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

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. CONCOMITANT MEDICAL PRODUCTS - BIOMET CRUCIATE TRAY, CATALOG 141236, LOT J3639655; VANGUARD FEMUR, CATALOG 183016, LOT 598140; SERIES A PATELLA, CATALOG 184768, LOT 753490. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 1825034-2017-03322, 1825034-2017-03323, AND 1825034-2017-04482.

    Additional Manufacturer Narrative · 1

    REPORTED EVENT WAS CONFIRMED THROUGH RECEIPT OF OPERATIVE NOTES. PRODUCT WAS NOT RETURNED. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED. REVIEW OF THE PRIMARY/REVISION OPERATIVE NOTES INDICATES THAT THE SURGEON NOTED NO COMPLICATIONS. HOWEVER, THERE WAS MINIMAL ADHERENCE TO THE BONE, EXCEPT ON THE POSTERIOR CONDYLE. THE COMPONENTS WERE IMPLANTED WITH THE CORRECT FIT AND ORIENTATION AS PER THE SURGICAL TECHNIQUE. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT THIS TYPE OF EVENT CAN OCCUR AND RISKS ARE ADDRESSED IN RISK DOCUMENTATION. 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 PATIENT UNDERWENT AN INITIAL KNEE ARTHROPLASTY ON AN UNKNOWN DATE. SUBSEQUENTLY, PATIENT UNDERWENT REVISION TOTAL KNEE ARTHROPLASTY DUE TO AN UNKNOWN REASON. NO COMPLICATIONS/DELAYS REPORTED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A RIGHT KNEE REVISION APPROXIMATELY ONE YEAR POST IMPLANTATION DUE TO PERSISTENT PAIN AND COMPONENT LOOSENING. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED. OPERATIVE NOTES PROVIDED STATED THE PATIENT WAS PREVIOUSLY TREATED FOR SUPERFICIAL INFECTION, HOWEVER, WITH CONTINUED SYMPTOMS AND EVIDENCE OF FEMORAL LOOSENING, AS WELL AS CULTURES NEGATIVE FOR INFECTION, THE DIAGNOSIS WAS PRESENTED AS PAIN WITH PROBABLE FEMORAL LOOSENING. OPERATIVE NOTES FURTHER NOTED THAT THE TIBIAL AND FEMORAL COMPONENTS WERE EASILY REMOVED WITH MINIMAL BONE LOSS. THE FEMORAL AND TIBIAL COMPONENTS AS WELL AS THE TIBIAL BEARING WERE REMOVED AND REPLACED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A RIGHT KNEE REVISION APPROXIMATELY ONE YEAR POST IMPLANTATION DUE TO PERSISTENT PAIN AND POSSIBLE COMPONENT LOOSENING. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED. REVISION OPERATIVE NOTES PROVIDED STATED THE PATIENT WAS PREVIOUSLY TREATED FOR SUPERFICIAL INFECTION, HOWEVER, WITH CONTINUED SYMPTOMS AND EVIDENCE OF FEMORAL LOOSENING, AS WELL AS NEGATIVE CULTURES FOR INFECTION, THE PRE-OPERATIVE DIAGNOSIS WAS PRESENTED AS PAIN WITH PROBABLE FEMORAL LOOSENING. DURING THE REVISION, IT WAS FURTHER NOTED THAT THE TIBIAL AND FEMORAL COMPONENTS WERE EASILY REMOVED WITH MINIMAL BONE LOSS. THERE WAS MINIMAL ADHERENCE OF THE COMPONENTS WITH THE BONE, EXCEPT ON THE POSTERIOR CONDYLE. THE FEMORAL AND TIBIAL COMPONENTS, AS WELL AS THE TIBIAL BEARING WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352993 VANGUARD COMPLETE KNEE SYSTEM - CR TIBIAL BEARING 10X79/83 KNEE PROSTHESIS JWH BIOMET ORTHOPEDICS 829170

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention