BEUDAMED
    FDA Adverse Event Injury Summary report: N

    E1 VNGD CR TIB BRG 87/91X10

    MDR report key: 12711148 · Received October 28, 2021

    Report

    Report Number
    0001825034-2021-02989
    Event Type
    Injury
    Date Received
    October 28, 2021
    Date of Event
    October 30, 2019
    Report Date
    March 26, 2025
    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
    IN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: A1; A6; B1; B4; B5; B6; D2; E1; E3; G1; G3; G6; H1; H2; H6. 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. THE FOLLOWING SECTIONS WERE UPDATED: B4; B5; D2; G1; G3; G6; H1; H2; H3; H6. THE EVENT IS CONFIRMED. REVIEW OF COMPLAINT HISTORY FOUND NO ADDITIONAL RELATED ISSUES FOR THIS ITEM AND THE REPORTED PART AND LOT COMBINATION. MEDICAL RECORDS AND RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS REVEALED PAIN WITH IMPLANT LOOSENING AND STIFFNESS. THE PATIENT HAD AN EXCESSIVE AMOUNT OF SCAR TISSUE THAT WAS THOROUGHLY DEBRIDED. THE TIBIAL POLY WAS REMOVED AND SHOWED SIGNIFICANT PITTING AND DELAMINATION WEAR AND THE TIBIAL IMPLANT WAS FOUND TO BE GROSSLY LOOSE AND WAS REMOVED. THERE WAS A FAIR AMOUNT OF BONE LOSS ON THE TIBIAL SIDE IN ADDITION TO RETAINED CEMENT AND A BONE RESECTION WAS MADE AT THE BASE OF THIS AND TIBIAL AUGMENTS WERE PLACED. 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 FURTHER REPORTED THAT THE PATIENT UNDERWENT AN INITIAL KNEE SURGERY AND APPROXIMATELY 6 YEARS POST-OP, THE PATIENT WAS REVISED DUE TO PAIN, STIFFNESS, AND LOOSENING. DURING THE REVISION, OSSIFICATION, TIBIAL POLY WEAR, BONE LOSS POSSIBLY RELATED TO ARTHRITIS, AND SIGNIFICANT SCAR TISSUE WERE NOTED. THE INITIAL PATELLA WAS RETAINED AND ALL OTHER COMPONENTS WERE REVISED. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL DEVICES: 183054 - VANGUARD CR POR FEM-RT 75 - 896370; 141237 - BIOMET CC CRUCIATE TRAY 87MM - J2572563; 184704 - SERIES A PAT W/WR STD 31 1 PEG - 910590. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. THE DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. REVIEW OF COMPLAINT HISTORY FOUND NO ADDITIONAL RELATED ISSUES FOR THIS ITEM AND THE REPORTED PART AND LOT COMBINATION. MEDICAL RECORDS WERE NOT PROVIDED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2021-02987, 0001825034-2021-02988, 0001825034-2021-02990.

    Description of Event or Problem · 1

    IT WAS REPORTED A PATIENT UNDERWENT A RIGHT KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO PAIN, LOOSENING, AND STIFFNESS APPROXIMATELY 6 YEARS LATER. THERE WERE NO CONTRIBUTING CONDITIONS TO THE EVENT. THERE WAS NO SURGICAL DELAY. THE SURGICAL TECHNIQUE WAS UTILIZED. NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1608240 E1 VNGD CR TIB BRG 87/91X10 PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 980440

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Hospitalization| R