BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORTHOPAEDIC SALVAGE SYSTEM POLY TIBIAL BUSHING

    MDR report key: 21036058 · Received December 30, 2024

    Report

    Report Number
    0001825034-2024-03066
    Event Type
    Injury
    Date Received
    December 30, 2024
    Report Date
    June 6, 2025
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    UDI-DI
    00880304002258
    PMA / PMN Number
    K002757
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 0

    (B)(4). D10 - CONCOMITANT DEVICES - ORTHOPAEDIC SALVAGE SYSTEM COMPRESS SHORT ANCHOR PLUG 10MM CATALOG #: 178552 LOT #: 148690, ORTHOPEDIC SALVAGE SYSTEM COMPRESS NUT CATALOG #: 178512 LOT #: 269230, ORTHOPAEDIC SALVAGE SYSTEM COMPRESS TRANSVERSE PIN 6PK 24MM CATALOG #: 178525 LOT #: 173280, ORTHOPAEDIC SALVAGE SYSTEM COMPRESS SMALL SHORT SPINDLE WITH PINS 600LBF CATALOG #: 178366 LOT #: 151440, ORTHOPAEDIC SALVAGE SYSTEM COMPRESS SHORT ANCHOR PLUG 10MM CATALOG #: 178552 LOT #: 148700, ORTHOPAEDIC SALVAGE SYSTEM COMPRESS XS SHORT SPINDLE WITH PINS 400LBF CATALOG #: 178362 LOT #: 204810, ORTHOPAEDIC SALVAGE SYSTEM COMPRESS TRANSVERSE PIN 6PK 24MM CATALOG #: 178525 LOT #: 197590, ORTHOPAEDIC SALVAGE SYSTEM COMPRESS NUT CATALOG #: 178512 LOT #: 269230, ORTHOPAEDIC SALVAGE SYSTEM COMPRESS 5CM TAPER ADAPTOR WITH SCREW CATALOG #: 178711 LOT #: 080030, ORTHOPAEDIC SALVAGE SYSTEM RS 9CM PROXIMAL MODULAR TIBIA CATALOG #: CP113461 LOT #: 357890, ORTHOPEDIC SALVAGE SYSTEM RS DISTAL FEMUR RIGHT 15CM CATALOG #: CP114842 LOT #: 459150, ORTHOPAEDIC SALVAGE SYSTEM REINFORCED YOKE CATALOG #: 150493 LOT #: 896980, ORTHOPAEDIC SALVAGE SYSTEM RS AXLE CATALOG #: 161035 LOT #: 514100, ORTHOPAEDIC SALVAGE SYSTEM POLY LOCKING PIN CATALOG #: 150478 LOT #: 432220. E1 - THE SURGEON'S NAME IS DR. (B)(6). THE COMPLAINANT HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE DEVICE REMAINS IMPLANTED. 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 AND CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, G3, G6, H2, H3, H6, H11. THE FOLLOWING SECTIONS WERE CORRECTED: H4. THE PRODUCT WAS EVALUATED THROUGH MANUFACTURING REVIEW, HOWEVER, THE REPORTED EVENT COULD NOT BE CONFIRMED. THE DEVICE HISTORY RECORDS WERE REVIEWED AND NO DISCREPANCIES WERE IDENTIFIED. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED WITH THE INFORMATION PROVIDED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT IS BEING CONSIDERED FOR A RIGHT KNEE ARTHROPLASTY REVISION TO ADDRESS FLEXION CONTRACTURE AND STIFFNESS APPROXIMATELY TWENTY-TWO (22) MONTHS FOLLOWING KNEE ARTHROPLASTY. ATTEMPTS HAVE BEEN MADE, HOWEVER, NO ADDITIONAL INFORMATION IS AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT IS BEING CONSIDERED FOR A RIGHT KNEE ARTHROPLASTY REVISION DUE TO UNKNOWN REASONS. ATTEMPTS HAVE BEEN MADE, HOWEVER, NO ADDITIONAL INFORMATION IS AVAILABLE.

    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
    2211560 ORTHOPAEDIC SALVAGE SYSTEM POLY TIBIAL BUSHING PROSTHESIS, KNEE JDI ZIMMER BIOMET, INC. N/A 65718067 00880304002258

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other