BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTICULAR SURFACE SIZE EF 12 MM HEIGHT USE WITH PLATE 5

    MDR report key: 18610051 · Received January 30, 2024

    Report

    Report Number
    0001822565-2024-00301
    Event Type
    Injury
    Date Received
    January 30, 2024
    Date of Event
    February 8, 2023
    Report Date
    August 6, 2025
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    UDI-DI
    00889024635005
    PMA / PMN Number
    K173057
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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: A3; A4; B1; B3; B4; B5; B6; B7; D2; D6A; D6B; D10; G1; G3; G6; H1; H2; H6. D10: 3095-040 - GENTAMICIN BONE CEMENT - 8616326. 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. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. THE DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. 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.

    Additional Manufacturer Narrative · 0

    (B)(4). D10 : 00596401651 - FEMORAL COMPONENT OPTION SIZE F LEFT COMPATIBLE WITH LPS-FLEX PROLONG - 63889244. 00598604701 - STEMMED NONAUGMENTABLE TIBIAL COMPONENT OPTION CR/PS/LPS SIZE 5 FOR CEMENTED USE ONLY - 63879679. UNKNOWN - DEPUY CEMVAC VACUUM MIXING SYSTEM - UNKNOWN. G2 : FOREIGN COUNTRY : UNITED KINGDOM. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 3007963827-2024-00024, 0002648920-2024-00024.

    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; H6. THE EVENT IS CONFIRMED. MEDICAL RECORDS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: CLINIC VISIT NOTES NOTED ASEPTIC LOOSENING OF THE TIBIAL COMPONENT, NO SIGNS OF INFECTION, AND INCREASED PAIN. LEFT KNEE REVISION NOTES NOTED THE LINER HAD ''BACKSIDE WEAR, MEDIAL SURFACE PITTING'', THE TIBIAL COMPONENT WAS GROSSLY LOOSE, AND A THERE WAS A PERFORATION IN THE ANTEROMEDIAL TIBIA FROM KEEL. ROOT CAUSE REMAINS UNCHANGED. 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 REPORTED THAT THE PATIENT UNDERWENT AN INITIAL LEFT TOTAL KNEE ARTHROPLASTY . SUBSEQUENTLY, THE PATIENT REPORTED A PAINFUL LEFT KNEE WITH SWELLING. X-RAYS SHOWED LUCENCY AROUND THE TIBIAL COMPONENT. SUBSEQUENTLY, THE PATIENT UNDERWENT A LEFT TOTAL KNEE REVISION APPROXIMATELY 5 YEARS POST-OP. DURING THE REVISION, THE SURGEON NOTED SYNOVITIS, POLY WEAR AND PITTING, AND TIBIAL LOOSENING. ALL COMPONENTS WERE REVISED WITHOUT COMPLICATIONS. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL LEFT KNEE SURGERY AND WAS REVISED APPROXIMATELY 5 YEARS LATER DUE TO UNKNOWN REASONS. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1073370 ARTICULAR SURFACE SIZE EF 12 MM HEIGHT USE WITH PLATE 5 PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 63850428 00889024635005

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention| H