BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORTHOPEDIC SALVAGE SYSTEM RS POLYETHYLENE FEMORAL BUSHINGS

    MDR report key: 8348416 · Received February 18, 2019

    Report

    Report Number
    0001825034-2019-00701
    Event Type
    Injury
    Date Received
    February 18, 2019
    Date of Event
    December 7, 2018
    Report Date
    November 13, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KRO
    PMA / PMN Number
    K021260
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE PRODUCT WAS EVALUATED THROUGH MANUFACTURING REVIEW AND THE REPORTED EVENT WAS CONFIRMED THROUGH REVIEW OF MEDICAL RECORDS. THE DEVICE HISTORY RECORDS WERE REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE IDENTIFIED. THE ROOT CAUSE IS ATTRIBUTED TO THE PROCEDURE PERFORMED WITH NO DEVICE FAILURE IDENTIFIED. 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

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

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL DEVICES ¿ ORTHOPEDIC SALVAGE SYSTEM MODULAR TIBIAL BASEPLATE 67MM, CATALOG #: 15042,1 LOT #: 523710; ORTHOPEDIC SALVAGE SYSTEM TIBIAL AUGMENT BLOCK 10 X 63/67MM, CATALOG #: 150426, LOT #: 225600; ORTHOPEDIC SALVAGE SYSTEM CEMENTED PROXIMAL TIBIAL STEM, CATALOG #: 150445, LOT #: 751190; ORTHOPEDIC SALVAGE SYSTEM 5CM REINFORCED YOLK, CATALOG #: 150493, LOT #: 065310; ORTHOPEDIC SALVAGE SYSTEM POLYETHYLENE TIBIAL BUSHING, CATALOG #: 150476, LOT #: 248130; ORTHOPEDIC SALVAGE SYSTEM RS AXLE, CATALOG #: 161035, LOT #: 257570; ORTHOPEDIC SALVAGE SYSTEM POLYETHYLENE LOCKING PIN, CATALOG #: 150510, LOT #: 211820; ORTHOPEDIC SALVAGE SYSTEM CEMENTED IM STEM 13MM X 225MM, CATALOG #: 150374, LOT #: 416160; ORTHOPEDIC SALVAGE SYSTEM DIAPHYSEAL LOCKING SCREW SET, CATALOG #: 150481, LOT #: 583850; ORTHOPEDIC SALVAGE SYSTEM 4CM DIAPHYSEAL SEGMENT, CATALOG #: 150482, LOT #: 034700; ORTHOPEDIC SALVAGE SYSTEM SEGMENTAL STACKING ADAPTER, CATALOG #: 150483, LOT #: 097170; ORTHOPEDIC SALVAGE SYSTEM 4CM DIAPHYSEAL SEGMENT, CATALOG #: 150482, LOT #: 899920, ORTHOPEDIC SALVAGE SYSTEM RS 7CM MODULAR SEGMENTED FEMORAL COMPONENT RIGHT CATALOG #: 161011, LOT #: 306670; ORTHOPEDIC SALVAGE SYSTEM POLYETHYLENE TIBIAL BEARING 16MM, CATALOG #: 150412, LOT #: 790410. THE COMPLAINANT HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS IT STILL REMAINS IMPLANTED. 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: 0001825034-2019-00696, 0001825034-2019-00697, 0001825034-2019-00698, 0001825034-2019-00699, 0001825034-2019-00700, 0001825034-2019-00702, 0001825034-2019-00703, 0001825034-2019-00704, 0001825034-2019-00705, 0001825034-2019-00706, 0001825034-2019-00707, 0001825034-2019-00708, 0001825034-2019-00709, 0001825034-2019-00710. DEVICE EVALUATED BY MFR? INVESTIGATION INCOMPLETE.

    Description of Event or Problem · 1

    IT IS REPORTED THAT DURING THE PATIENT¿S POST-OPERATIVE STAY FOR KNEE ARTHROPLASTY, THE PATIENT EXPERIENCED LOW HEMOGLOBIN AND HEMATOCRIT LEVELS AND REQUIRED A BLOOD TRANSFUSION FOR POST-OPERATIVE ANEMIA. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    140972 ORTHOPEDIC SALVAGE SYSTEM RS POLYETHYLENE FEMORAL BUSHINGS PROSTHESIS, KNEE KRO ZIMMER BIOMET, INC. N/A 261210

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention