BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORTHOPEDIC SALVAGE SYSTEM MAK SEGMENTAL FEMORAL COMPONENT

    MDR report key: 22144620 · Received June 4, 2025

    Report

    Report Number
    0001825034-2025-01581
    Event Type
    Injury
    Date Received
    June 4, 2025
    Report Date
    October 15, 2025
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KRO
    UDI-DI
    00880304654051
    PMA / PMN Number
    K131393
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10 - CONCOMITANT DEVICES - ORTHOPEDIC SALVAGE SYSTEM POLYETHYLENE TIBIAL BEARING 14MM CATALOG #: 150411 LOT #: 66071322, ORTHOPEDIC SALVAGE SYSTEM MAK BUMPER CATALOG #: CP113824 LOT #: 66152484, ORTHOPEDIC SALVAGE SYSTEM REINFORCED YOKE CATALOG #: 150493 LOT #: 66013906, ORTHOPEDIC SALVAGE SYSTEM POLYETHYLENE TIBIAL BUSHING CATALOG #: 150476 LOT #: 65725192, ORTHOPEDIC SALVAGE SYSTEM MAK SIDE LOCK STEM SCREW CATALOG #: CP113455 LOT #: 107070, ORTHOPEDIC SALVAGE SYSTEM MAK LOCK PIN CATALOG #: 110008542 LOT #: 66270288, PERSONA CENTRAL TIBIAL CONE SIZE MEDIUM CATALOG #: 42545000512 LOT #: 65115426, ORTHOPEDIC SALVAGE SYSTEM AXLE CATALOG #: 150480 LOT #: 65859999, PERSONA CENTRAL TIBIAL CONE CATALOG #: 42545000508 LOT #: 65871054, ORTHOPEDIC SALVAGE SYSTEM ARCOS IM FEMORAL ROD 28CM CATALOG #: 151869 LOT #: 65725357, ORTHOPEDIC SALVAGE SYSTEM ELLLIPTICAL DIAPHYSEAL SEGMENT 3CM CATALOG #: 150461 LOT #: 66058528, ORTHOPEDIC SALVAGE SYSTEM POLYETHYLENE FEMORAL BUSHINGS CATALOG #: 150477 LOT #: 66205647, ORTHOPEDIC SALVAGE SYSTEM SEGMENTAL STACKING ADAPTER CATALOG #: 150483 LOT #: 66244007. H6 - COMPONENT CODE - PROPOSED CODE IS MECHANICAL (G04) - FEMUR. THE COMPLAINANT HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE DEVICES REMAIN 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 INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, G3, G6, H2, H3, H6, H11. RADIOGRAPHIC EVALUATION NOTED A CRACK IN THE CEMENT MANTLE AND MEDICAL RECORDS CONFIRMED THE PATIENT WAS EXPERIENCING TENDERNESS IN THE MEDIAL AND LATERAL JOINT LINE AND RETINACULUM WITH SWELLING. 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 EXPERIENCING PAIN, SWELLING AND DIFFICULTY AMBULATING APPROXIMATELY SIXTEEN MONTHS FOLLOWING RIGHT KNEE ARTHROPLASTY. INITIAL OPERATIVE NOTES NOTE NO INTRAOPERATIVE COMPLICATIONS.

    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
    398371 ORTHOPEDIC SALVAGE SYSTEM MAK SEGMENTAL FEMORAL COMPONENT PROSTHESIS, KNEE KRO ZIMMER BIOMET, INC. N/A 898670 00880304654051

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other SEE H11 NARRATIVE