BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN POLY

    MDR report key: 20976751 · Received December 19, 2024

    Report

    Report Number
    0001825034-2024-03022
    Event Type
    Injury
    Date Received
    December 19, 2024
    Date of Event
    August 12, 2021
    Report Date
    March 21, 2025
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    NI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    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: A4; B4; B5; B6; B7; D1; D2; D4; D6A; D10; G1; G3; G6; H1; H2; H6 D10: 161073 - OSS AVL TIBIAL LOCK RING - 294120 161071 - OSS AVL POLY TIB BUSHING SET- 594260 161073 - OSS AVL TIBIAL LOCK RING - 385850 UNKNOWN - UNKNOWN YOKE - 382190 UNKNOWN - UNKNOWN RS DISTAL FEMUR - UNKNOWN UNKNOWN - UNKNOWN FEMORAL AXLE - UNKNOWN UNKNOWN - UNKNOWN FEMORAL BUSHINGS - UNKNOWN 178512 - CPS NUT CO-CR-MO ALLOY - 123500 178402 - CPS ANCHOR PLUG 12MM - 791910 178404 - CPS ANCHOR PLUG 14MM - 791920 178504 - CPS LG H F SPINDLE 12MM PC HA - 619550 178612 - EXP DSTL FEM 17CM LEFT ASSY - 279450 178527 - CPS TRANSVERSE PIN 6PK 32MM - 324740 178530 - CPS TRANSVERSE PIN 6PK 44MM - 933150 178537 - CPS CENTERING SLEEVE 15MM - 335580 178538 - CPS CENTERING SLEEVE 16MM - 131480 PM103043 - PLUYM CSTM TIB COMPRESS 400LB - 045130 CP114664 - MAXIM-OSS 3CM SEGMENT - 519990 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 HAVE BEEN UPDATED: B4; B5; G3; H2; H6; H11. VISUAL EXAMINATION OF THE PROVIDED PICTURES IDENTIFIED SIGNS OF IMPLANTATION AS THE SURFACE SHOWS NICKS, GOUGES, AND SCRATCHES. THE PRODUCT ETCHING IS FADED AND THE IMPLANT SHOWS DISCOLORATION ON ITS EDGES. AS THE PRODUCT WAS NOT RETURNED, FURTHER EVALUATIONS COULD NOT BE PERFORMED. DEVICE HISTORY RECORD REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. MEDICAL RECORDS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: REVISION OP REPORT: REVISION DUE TO DISLOCATION POLY OSS PROSTHESIS. INSPECTION: BREAK FIXATION RING TO FIX THE POLY OF THE OSS PROSTHESIS WITH DISLOCATION OF THE POLY. REMOVE OLD POLY AND OLD FIXATION RING AND RINSE THOROUGHLY. INSERT THICKER POLY +4MM AND REASSEMBLE SYSTEM WITH NEW FIXATION RING. ROOT CAUSE WAS UNABLE TO BE DETERMINED. REPORTED EVENT WAS CONFIRMED BY REVIEW OF PROVIDED MEDICAL RECORDS. 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.

    Additional Manufacturer Narrative · 0

    (B)(4). D10 : 161073 - OSS AVL TIBIAL LOCK RING - 385850; 161071 - OSS AVL POLY TIB BUSHING SET - 594260. G2 : FOREIGN COUNTRY : EUROPE : BELGIUM. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION AS IT HAS BEEN DISCARDED. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT UNDERWENT AN ARTHRODESIS KNEE PROCEDURE UTILIZING PATIENT MATCHED IMPLANTS. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO DISLOCATION OF THE POLY. THE HINGE COMPONENTS WERE REVISED. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AT TIME OF THIS REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A KNEE SURGERY. APPROXIMATELY 2 YEARS POST-OP, THE PATIENT WAS REVISED DUE TO A FRACTURED LOCKING RING AND TIBIAL BUSHING, POLY WEAR, AND LUXATION OF THE POLY. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2083067 UNKNOWN POLY PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Male Required Intervention| H SEE H11.| SEE H11.