BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORTHOPAEDIC SALVAGE SYSTEM CEMENTED IM STEM 9MM X 90MM

    MDR report key: 17774919 · Received September 19, 2023

    Report

    Report Number
    0001825034-2023-02193
    Event Type
    Injury
    Date Received
    September 19, 2023
    Date of Event
    August 31, 2023
    Report Date
    January 10, 2024
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    PMA / PMN Number
    K002757
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND CORRECTED INFORMATION. D10 - CONCOMITANT DEVICES - ORTHOPAEDIC SALVAGE SYSTEM MODULAR TIBIAL BASEPLATE 75MM CATALOG #: 150423 LOT #: 026290, UNKNOWN ORTHOPAEDIC SALVAGE SYSTEM FEMORAL COMPONENT CATALOG #: NI LOT #:, ORTHOPAEDIC SALVAGE SYSTEM CEMENTED IM FEMORAL STEM 9MM X 90MM CATALOG #: 150358 LOT #: 489680, ORTHOPAEDIC SALVAGE SYSTEM TIBIAL POLYETHYLENE BEARING 16MM CATALOG #: 150412 LOT #: 768240, ORTHOPAEDIC SALVAGE SYSTEM TIBIAL POLYETHYLENE BEARING 12MM CATALOG #: 150410 LOT #: 262380, ORTHOPAEDIC SALVAGE SYSTEM AXLE CATALOG #: 150480 LOT #: 048510, ORTHOPAEDIC SALVAGE SYSTEM REINFORCED YOKE CATALOG #: 150493 LOT #: 778990, ORTHOPAEDIC SALVAGE SYSTEM POLY LOCKING PIN CATALOG #: 150478 LOT #: 010010, ORTHOPAEDIC SALVAGE SYSTEM POLYETHYLENE FEMORAL BUSHINGS CATALOG #: 150477 LOT #: 165410, ORTHOPAEDIC SALVAGE SYSTEM POLYETHYLENE TIBIAL BUSHING CATALOG #: 150476 LOT #: 097340.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND CORRECTED INFORMATION. H6 - COMPONENT CODE - PROPOSED CODE IS MECHANICAL (G04) - STEM. VISUAL EVALUATION OF PICTURES PROVIDED IDENTIFIED THE TIBIAL IMPLANT STILL ASSEMBLED TO THE STEM. BOTH DEVICES WERE COATED IN FOREIGN MATERIAL. MEDICAL RECORDS PROVIDED DID NOT PROVIDE ANY INFORMATION REGARDING THE PATIENT'S POST-OPERATIVE COMPLICATIONS. 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.

    Additional Manufacturer Narrative · 0

    (B)(4). D10 - CONCOMITANT DEVICES - UNKNOWN ORTHOPAEDIC SALVAGE SYSTEM TIBIAL TRAY CATALOG #: NI LOT #: NI, UNKNOWN ORTHOPAEDIC SALVAGE SYSTEM FEMORAL COMPONENT CATALOG #: NI LOT #: NI, UNKNOWN ORTHOPAEDIC SALVAGE SYSTEM FEMORAL STEM CATALOG #: NI LOT #: NI, UNKNOWN ORTHOPAEDIC SALVAGE SYSTEM FEMORAL AUGMENT CATALOG #: NI LOT #: NI G2 - REPORT SOURCE - FOREIGN: THE EVENT OCCURRED IN AUSTRALIA. THE COMPLAINANT HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS PATIENT; PLEASE SEE ALL REPORTS ASSOCIATED WITH THIS EVENT: 0001825034-2023-02192. 0001825034-2023-02194. 0001825034-2023-02195. 0001825034-2023-02196. H3 OTHER TEXT : INSUFFICIENT INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A KNEE ARTHROPLASTY REVISION TO ADDRESS TIBIAL IMPLANT LOOSENING APPROXIMATELY ELEVEN (11) YEARS POST-OPERATIVELY. INITIAL OPERATIVE NOTES NOTED NO INTRAOPERATIVE COMPLICATIONS. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A KNEE ARTHROPLASTY REVISION TO ADDRESS IMPLANT LOOSENING APPROXIMATELY ELEVEN (11) YEARS POST-OPERATIVELY. ATTEMPTS HAVE BEEN MADE; HOWEVER, NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1342733 ORTHOPAEDIC SALVAGE SYSTEM CEMENTED IM STEM 9MM X 90MM PROSTHESIS, KNEE JDI ZIMMER BIOMET, INC. N/A 489680
    2062166 ORTHOPAEDIC SALVAGE SYSTEM CEMENTED IM STEM 9MM X 90MM PROSTHESIS, KNEE JDI ZIMMER BIOMET, INC. N/A 489680

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention| H