BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORTHOPEDIC SALVAGE SYSTEM IM STEM WITH SCREW 11MM X 150MM

    MDR report key: 22096957 · Received May 28, 2025

    Report

    Report Number
    0001825034-2025-01507
    Event Type
    Injury
    Date Received
    May 28, 2025
    Date of Event
    December 11, 2023
    Report Date
    November 12, 2025
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    UDI-DI
    00880304033702
    PMA / PMN Number
    K123501
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    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: B4, G3, G6, H2, H3, H6, H11. MEDICAL RECORDS PROVIDED CONFIRMED THE REPORTED EVENT. THE DEVICE HISTORY RECORDS WERE REVIEWED AND NO DISCREPANCIES WERE IDENTIFIED. THE IMPLANTS WERE NOTED TO HAVE BEEN USED WITH COMPETITOR IMPLANTS. THE INSTRUCTIONS FOR USE FOR THE IMPLANTS USED NOTE NOT TO NOT USE COMPONENTS OF ZIMMER BIOMET WITH COMPONENTS OF ANY OTHER SYSTEM OR MANUFACTURER UNLESS AUTHORIZED BY ZIMMER BIOMET, HOWEVER, 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 - MAK OSS RS SEGMENTAL ELLIPTICAL FEMORAL COMPONENT 7CM RIGHT CATALOG #: CP113814 LOT #: 236800, OSS RS NON-MODULAR TIBIAL PLATE LONG 71MM CATALOG #: 161041 LOT #: 748420, MAK OSS SIDE LOCK STEM SCREW CATALOG #: CP113455 LOT #: 007740, OSS REINFORCED YOKE CATALOG #: 150493 LOT #: 901630, OSS POLY TIBIAL BUSHING CATALOG #: 150476 LOT #: 923020, OSS MAK LOCK PIN CATALOG #: 110008542 LOT #: 250450, OSS POLYETHYLENE TIBIAL BEARING 16MM CATALOG #: 150412 LOT #: 153950, MAK OSS BUMPER CATALOG #: CP113824 LOT #: 976830, OSS RS AXLE CATALOG #: 161035 LOT #: 902650, OSS RS POLYETHYLENE FEMORAL BUSHINGS SET OF 2 CATALOG #: 161034 LOT #: 919000. H6 - COMPONENT CODE - PROPOSED CODE IS MECHANICAL (G04) STEM. 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.

    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 RIGHT KNEE ARTHROPLASTY REVISION TO ADDRESS PAIN, FEMORAL COMPONENT LOOSENING AND A RIGHT FEMORAL STRESS FRACTURE APPROXIMATELY THREE (3) YEARS POST-OPERATIVELY. ALL COMPONENTS WERE REVISED AND REPLACED. INITIAL OPERATIVE NOTES NOTED NO INTRAOPERATIVE COMPLICATIONS. REVISION OPERATIVE NOTES NOTED GROSS MOTION OF THE FEMORAL IMPLANT WITHIN THE BONE, INDICATIVE OF FIBROUS UNION. ASSESSMENT OF FEMORAL AND TIBIAL BONE DEFECTS WERE ADDITIONALLY NOTED. NO IMPLANTS WERE PLACED WITHOUT COMPLICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329269 ORTHOPEDIC SALVAGE SYSTEM IM STEM WITH SCREW 11MM X 150MM PROSTHESIS, KNEE JDI ZIMMER BIOMET, INC. N/A 733890 00880304033702

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Male Hospitalization| R SEE H11 NARRATIVE.