BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAK ORTHOPEDIC SALVAGE SYSTEM RS DISTAL FEMORAL COMPONENT LEFT 8.5

    MDR report key: 22108199 · Received May 29, 2025

    Report

    Report Number
    0001825034-2025-01521
    Event Type
    Injury
    Date Received
    May 29, 2025
    Report Date
    October 15, 2025
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KRO
    UDI-DI
    00880304653952
    PMA / PMN Number
    K083779
    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

    (B)(4). D10 - CONCOMITANT DEVICES - ORTHOPEDIC SALVAGE SYSTEM SMOOTH STRAIGHT IM STEM 11MM X 150MM, CATALOG #: CP111649, LOT #: 137310; ORTHOPEDIC SALVAGE SYSTEM RS NON-MODULAR TIBIAL PLATE 67MM, CATALOG #: 161039, LOT #: 688410; ORTHOPEDIC SALVAGE SYSTEM RS AXLE, CATALOG #: 161035, LOT #: 228810; ORTHOPEDIC SALVAGE SYSTEM RS POLYETHYLENE FEMORAL BUSHINGS, CATALOG #: 161034, LOT #: 685750; ORTHOPEDIC SALVAGE SYSTEM MAK LOCKING PIN, CATALOG #: 110008542 LOT #: 251420; ORTHOPEDIC SALVAGE SYSTEM REINFORCED YOKE, CATALOG #: 150493, LOT #: 911970; ORTHOPEDIC SALVAGE SYSTEM MAK SIDE LOCK STEM SCREW, CATALOG #: CP113455, LOT #: 603040; ORTHOPEDIC SALVAGE SYSTEM SEGMENTAL STACKING ADAPTER, CATALOG #: 150483, LOT #: 259360; ORTHOPEDIC SALVAGE SYSTEM POLYETHYLENE TIBIAL BUSHING, CATALOG #: 150476, LOT #: 221860; ORTHOPEDIC SALVAGE SYSTEM MAK BUMPER, CATALOG #: CP113824, LOT #: 151920; ORTHOPEDIC SALVAGE SYSTEM POLYETHYLENE TIBIAL BEARING 12MM, CATALOG #: 150410, LOT #: 050980; ORTHOPEDIC SALVAGE SYSTEM ELLIPTICAL DIAPHYSEAL SEGMENT 3CM, CATALOG #: 150461, LOT #: 328080; ORTHOPEDIC SALVAGE SYSTEM RS PROXIMAL TIBIAL SLEEVE 3CM, CATALOG #: 161023, LOT #: 620850. 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 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 INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, G3, G6, H2, H3, H4, H6, H11. RADIOGRAPHIC EVALUATION CONFIRMED A RADIOLUCENT LINE AROUND THE FEMORAL COMPONENT AND MEDICAL RECORDS CONFIRMED THE PATIENT WAS EXPERIENCING TENDERNESS WITH MODERATE 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 CONTINUED PAIN AND SWELLING WITH FEMORAL COMPONENT RADIOLUCENCY AND POSSIBLE LOOSENING APPROXIMATELY FIVE (5) YEARS FOLLOWING LEFT KNEE ARTHROPLASTY. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED. 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
    596942 MAK ORTHOPEDIC SALVAGE SYSTEM RS DISTAL FEMORAL COMPONENT LEFT 8.5 PROSTHESIS, KNEE KRO ZIMMER BIOMET, INC. N/A 230960 00880304653952

    Patients

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