BEUDAMED
    FDA Adverse Event Injury Summary report: Y

    UNKNOWN NEXGEN LEGACY CONSTRAINED CONDYLAR KNEE ARTICULAR SURFACE

    MDR report key: 22708421 · Received August 4, 2025

    Report

    Report Number
    0001822565-2025-02782
    Event Type
    Injury
    Date Received
    August 4, 2025
    Date of Event
    October 16, 2024
    Report Date
    April 14, 2026
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED: B4, B5, D2, G1, G3, G6, H1, H2, H11. H1: THIS MDR IS BEING SUBMITTED AS A PART OF A RETROSPECTIVE LITERATURE MDR REPORTING REVIEW AND REMEDIATION EFFORT BASED ON MDR REPORTING PROCESS AND FDA ADVERSE EVENT REPORTING REQUIREMENT. CAPA -07984 WAS OPENED ON FEB 27, 2026 TO ADDRESS CORRECTIONS. DEVICE PERFORMANCE AND/OR RISK PROFILE ARE NOT IMPACTED. IF ANY FURTHER INFORMATION WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 0

    (B)(4). D10: MEDICAL PRODUCT: UNKNOWN NEXGEN LEGACY CONSTRAINED CONDYLAR KNEE (LCCK) FEMORAL COMPONENT: CATALOG#NI, LOT#NI; UNKNOWN NEXGEN LEGACY CONSTRAINED CONDYLAR KNEE (LCCK) TIBIAL TRAY: CATALOG#NI, LOT#NI. G2: FOREIGN: CANADA. G2: LITERATURE: MADANIPOUR S, HOWARD LC, MASRI BA, GREIDANUS NV, GARBUZ DS, NEUFELD ME. OUTCOMES OF LINER EXCHANGE VERSUS COMPONENT REVISION FOR THE TREATMENT OF STIFFNESS FOLLOWING PRIMARY TOTAL KNEE ARTHROPLASTY. J ARTHROPLASTY. 2025 APR;40(4):1014-1020. DOI: 10.1016/J.ARTH.2024.10.014. EPUB 2024 OCT 16. PMID: 39419417. THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE PRODUCT LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. UPON COMPLETION OF THE INVESTIGATION, 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; H10. ATTEMPTS HAVE BEEN MADE TO GATHER ALL PRODUCT IDENTIFICATION INFORMATION AND NO FURTHER INFORMATION HAS BEEN PROVIDED. THE EVENT CANNOT BE CONFIRMED. NO PRODUCT WAS RETURNED, OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. THE DEVICE HISTORY RECORD WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. 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.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    ON 10 JULY 2025 A JOURNAL ARTICLE WAS RETRIEVED FROM THE JOURNAL OF ARTHROPLASTY (16 OCTOBER 2024) THAT REPORTED A STUDY FROM CANADA. THE PURPOSE OF THE STUDY WAS TO COMPARE OUTCOMES OF REVISION TOTAL KNEE ARTHROPLASTY (TKA) WITH LINER EXCHANGE (LE) VERSUS COMPONENT REVISION (CREV) FOR STIFFNESS POST INITIAL TKA. THE STUDY REVIEWED RETROSPECTIVE PATIENT MEDICAL RECORDS FROM THERE INSTITUTIONAL DATABASE FOR TKAS PERFORMED BETWEEN 12 JUNE 2003-06 AUGUST 2021. THE STUDY INCLUDED A TOTAL OF 129 KNEES THAT UNDERWENT EITHER LE OR CREV. A TOTAL OF 91 LE AND 39 CREV WERE INCLUDED IN THE STUDY POPULATION. REVISION SURGERY WAS PERFORMED BY SUBSPECIALTY ARTHROPLASTY-TRAINED SURGEONS. THE AVERAGE TIME FROM PRIMARY TKA TO CREV WAS 27 MONTHS WITH 35 MONTH AVERAGE FROM PRIMARY TO LE. MULTIPLE MANUFACTURER CONSTRUCTS WERE INCLUDED IN THE STUDY, ZIMMER BIOMET SPECIFIC CONSTRUCTS INCLUDED THE FOLLOWING: NEXGEN, VANGUARD, LCCK AND PERSONA COMPONENTS. THE STUDY POPULATION HAD A MEAN AGE OF 63 YEARS AT TIME OF SURGERY WITH 78 OF THE 129 WERE WOMEN. FOLLOW-UP WAS CONDUCTED AT A MINIMAL OF 2 YEARS, WITH A MEAN LENGTH OF FOLLOW-UP FOR 8.5 YEARS (RANGE 2 TO 21). IT WAS REPORTED THAT TWENTY (20) PATIENTS UNDERWENT A SECOND REVISION OF COMPONENTS DUE TO STIFFNESS AND LIMITED RANGE OF MOTION ON AN UNKNOWN TIMEFRAME POST-IMPLANTATION. DUE DILIGENCE IS COMPLETE AS MULTIPLE ATTEMPTS HAVE BEEN MADE HOWEVER NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2153626 UNKNOWN NEXGEN LEGACY CONSTRAINED CONDYLAR KNEE ARTICULAR SURFACE PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. NI

    Patients

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