BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORTHOPEDIC SALVAGE SYSTEM COMPRESS SEGMENTAL FEMORAL COMPONENT LEFT 8.5CM

    MDR report key: 8387329 · Received March 4, 2019

    Report

    Report Number
    0001825034-2019-00945
    Event Type
    Injury
    Date Received
    March 4, 2019
    Date of Event
    February 7, 2019
    Report Date
    July 23, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KRO
    PMA / PMN Number
    K080330
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT WAS CONFIRMED BY REVIEW OF RADIOGRAPHS RECEIVED. REVIEW OF THE PROVIDED RADIOGRAPHS BY A HEALTH CARE PROFESSIONAL NOTED THE FOLLOWING: "AP AND LATERAL FILM OF THE LEFT KNEE DEMONSTRATES A HINGED PROSTHESIS OF THE LEFT KNEE WITH DISTAL FEMORAL RESECTION. TIBIAL COMPONENT DEMONSTRATES SIGNIFICANT LUCENCY AT THE BONE CEMENT INTERFACE OF THE ENTIRE TIBIAL STEM AS WELL AS THE MEDIAL AND LATERAL TIBIAL PLATEAU SUGGESTING LOOSENING. NO DISLOCATION. CURVILINEAR OSSIFICATION ALONG THE ANTERIOR ASPECT OF THE JOINT, LIKELY RELATES TO RESIDUAL PATELLA. SIGNIFICANT FLUID WITHIN THE JOINT." AS THERE WAS NO INDICATION OF TIBIAL LOOSENING AFTER THE REVISION WAS PERFORMED IT IS BELIEVED THAT THE RADIOLUCENCY IDENTIFIED IS STABLE AND LOSS OF FIXATION OF THE TIBIAL COMPONENT IS NOT OCCURRING. VISUAL INSPECTION OF THE RETURNED FEMUR, CENTERING SLEEVE, AND SPINDLE SHOWED NO EVIDENCE OF BREAKAGE OR FRACTURE. FURTHER EXAMINATION OF THE SPINDLE SHOWS EVIDENCE OF BONY IN-GROWTH SUGGESTING FIXATION. THE ANCHOR PLUG WAS NOT RETURNED FOR EVALUATION. DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS - UNKNOWN ORTHOPEDIC SALVAGE SYSTEM TIBIAL COMPONENT CATALOG #: NI LOT #: 201250, ORTHOPEDIC SALVAGE SYSTEM COMPRESS CENTERING SLEEVE 21MM CATALOG #: 178543 LOT #: 775230, ORTHOPEDIC SALVAGE SYSTEM REINFORCED YOLK CATALOG #: 150493 LOT #: 813400, ORTHOPEDIC SALVAGE SYSTEM COMPRESS SPINDLE WITH PINS CATALOG #: 178363 LOT #: 281320. REPORT SOURCE - FOREIGN: (B)(6). THE COMPLAINANT HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT UNDERWENT A KNEE ARTHROPLASTY REVISION TO ADDRESS DIFFICULTY BENDING THE LEG AND POTENTIAL ROTATION OF THE FEMORAL COMPONENT APPROXIMATELY TWO (2) MONTHS POST-OPERATIVELY. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    181779 ORTHOPEDIC SALVAGE SYSTEM COMPRESS SEGMENTAL FEMORAL COMPONENT LEFT 8.5CM PROSTHESIS, KNEE KRO ZIMMER BIOMET, INC. N/A 709750

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R