BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN NEXGEN TRIAL TRAY

    MDR report key: 22990584 · Received September 8, 2025

    Report

    Report Number
    0001822565-2025-03304
    Event Type
    Injury
    Date Received
    September 8, 2025
    Date of Event
    September 4, 2024
    Report Date
    September 24, 2025
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). B3: EVENT DATE IS THE PUBLICATION DATE OF THE ARTICLE. D4: THE PRIMARY UNIQUE DEVICE IDENTIFICATION (UDI) NUMBER IS NOT APPLICABLE AS THE DEVICE'S PRODUCT NUMBER IS UNKNOWN. D10: UNKNOWN NEXGEN FEMORAL COMPONENT; ITEM NUMBER: UNKNOWN; LOT NUMBER: UNKNOWN UNKNOWN NEXGEN BEARING; ITEM NUMBER: UNKNOWN; LOT NUMBER: UNKNOWN G2: FRANCE. JOURNAL ARTICLE CITATION: RATE OF COMPLICATIONS AND SHORT-TERM FUNCTIONAL RESULTS OF REVISION TOTAL KNEE ARTHROPLASTY FOR TIBIO-FEMORAL INSTABILITY: DO STABILITY AND RANGE OF MOTION ARE RESTORED IN 62 REVISIONS. ANTOINE LABOUYRIE, JULIEN D RTUS, SOPHIE PUTMAN, TEDDY TROUILLEZ, HENRI MIG UD, GILLES PSQUIER. ORTHOPAEDICS & TRAUMATOLOGY: SURGERY & RESEARCH. HTTPS://DOI.ORG/10.1016/J.OTSR.2024.103986. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, G3, G6, H2, H6, H10, H11 D4: THE PRIMARY UNIQUE DEVICE IDENTIFICATION (UDI) NUMBER IS NOT APPLICABLE AS THE DEVICE'S PRODUCT NUMBER IS UNKNOWN. ATTEMPTS HAVE BEEN MADE TO GATHER ALL PRODUCT IDENTIFICATION INFORMATION, AND NO FURTHER INFORMATION HAS BEEN PROVIDED. NO PRODUCT WAS RETURNED, AND NO PICTURES WERE PROVIDED; THEREFORE, A PRODUCT EVALUATION COULD NOT BE PERFORMED. PART AND LOT IDENTIFICATION ARE NECESSARY FOR REVIEW OF DEVICE HISTORY RECORDS; NEITHER WAS PROVIDED. INSUFFICIENT INFORMATION PROVIDED. UNABLE TO PERFORM A COMPATIBILITY CHECK. A REVIEW OF COMPLAINT HISTORY CANNOT BE PERFORMED WITHOUT PRODUCT IDENTIFICATION. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND THAT 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

    A JOURNAL ARTICLE WAS RETRIEVED FROM ORTHOPAEDICS & TRAUMATOLOGY: SURGERY & RESEARCH (2024) THAT REPORTED A RETROSPECTIVE STUDY FROM FRANCE. THE PURPOSE OF THE STUDY WAS TO ANALYZE THE ONE YEAR FUNCTIONAL RESULTS, DETERMINE THE RATE OF COMPLICATIONS AFTER REVISION FOR TIBIO-FEMORAL INSTABILITY USING POSTERIOR-STABILIZED OR CONDYLAR CONSTRAINED KNEES, AND IDENTIFY THE FACTORS THAT COULD INFLUENCE THE FUNCTIONAL OUTCOME. THE STUDY REVIEWED 62 REVISION CASES DUE TO ISOLATED INSTABILITY BETWEEN DECEMBER 2015 TO DECEMBER 2021, PERFORMED BY EIGHT SENIOR SURGEONS. INSTABILITY WAS CLASSIED AS INSTABILITY IN EXTENSION (N = 28), MIDFLEXION (N = 12), FLEXION (N = 12) OR GLOBAL (N = 15). REVISION CONSISTED IN IMPLANT REVISION USING A CCK (N = 42), A HINGE PROSTHESIS (N = 12) OR AN ISOLATED POLYETHYLENE INSERT EXCHANGE (N = 8). REVISION TOTAL KNEE ARTHROPLASTY CONSISTED IN REVISION OF FEMORAL AND TIBIAL COMPONENTS USING A CCK TKA (N = 48) (LCCK, ZIMMER-BIOMET, WARSAW, IN, USA) OR ROTATING HINGE PROSTHESIS (N = 9) (5 GENUX-MUTARS¿, IMPLANCAST BUTHEXUDE, GERMANY AND 4 NEXGEN RHK [ZIMMER-BIOMET, WARSAW, IN, USA]). A HINGE PROSTHESIS WAS PREFERRED TO A CCK IN CASES OF ADVANCED AGE OR MAJOR CO-MORBIDITIES, SIGNIFICANT BONE LOSS AFTER IMPLANT REMOVAL, OR COMPLETE DEFICIENCY OF ONE OF THE COLLATERAL LIGAMENTS. AN ISOLATED POLYETHYLENE INSERT EXCHANGE (N = 8) WAS PERFORMED ON PATIENTS WITH MODERATE GLOBAL INSTABILITY THE STUDY POPULATION HAD A MEAN AGE OF 62.9 YEARS ± 8.2 YEARS AT TIME OF SURGERY (RANGE 45.7¿78.4)); (22 MALES/40 FEMALES). PATIENTS WERE ASSESSED AT ONE YEAR BY THE DIFFERENCE BETWEEN THE PREOPERATIVE OXFORD KNEE SCORE (OKS) AND THE SCORE AT ONE YEAR POSTOPERATIVELY. THE STUDY REPORTED ONE PATIENT WAS REREVISED AT TEN MONTHS POST-OPERATIVE DUE TO ASEPTIC LOOSENING. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.

    Description of Event or Problem · 0

    DILIGENCE IS COMPLETED, AND NO FURTHER INFORMATION ON THE REPORTED EVENT HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2055404 UNKNOWN NEXGEN TRIAL TRAY PROTHESIS, KNEE JWH ZIMMER BIOMET, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| H SEE H11 NARRATIVE.