BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORTHOPEDIC SALVAGE SYSTEM REINFORCED YOKE

    MDR report key: 13548447 · Received February 17, 2022

    Report

    Report Number
    0001825034-2022-00354
    Event Type
    Injury
    Date Received
    February 17, 2022
    Date of Event
    February 7, 2022
    Report Date
    July 28, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KRO
    UDI-DI
    00880304240094
    PMA / PMN Number
    K052685
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). CONCOMITANT MEDICAL DEVICES - ORTHOPEDIC SALVAGE SYSTEM RS LS TIBIAL BEARING 20MM CATALOG #: 161098 LOT #: 967760, ORTHOPEDIC SALVAGE SYSTEM RS POLYETHYLENE FEMORAL BUSHINGS CATALOG #: 161034 LOT #: NI, ORTHOPEDIC SALVAGE SYSTEM RS AXLE CATALOG #: 161035 LOT #: NI, UNKNOWN ORTHOPEDIC SALVAGE SYSTEM LOCK PIN CATALOG #: NI LOT #: NI, UNKNOWN ORTHOPEDIC SALVAGE SYSTEM TIBIAL BUSHING CATALOG #: NI LOT #: NI, UNKNOWN ORTHOPEDIC SALVAGE SYSTEM RS SEGMENTAL DISTAL FEMUR CATALOG #: NI LOT #: NI, UNKNOWN ORTHOPEDIC SALVAGE SYSTEM RS NON-MODULAR TIBIA CATALOG #: NI LOT #: NI. REPORT SOURCE - FOREIGN: (B)(6). THE COMPLAINANT HAS NOT YET INDICATED WHETHER THE PRODUCT WILL 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS PATIENT; PLEASE SEE ALL REPORTS ASSOCIATED WITH THIS EVENT: 0001825034-2022-00355. INVESTIGATION INCOMPLETE.

    Additional Manufacturer Narrative · 0

    D10 - CONCOMITANT DEVICES - ORTHOPEDIC SALVAGE SYSTEM RS LS TIBIAL BEARING 20MM CATALOG #: 161098 LOT #: 967760, ORTHOPEDIC SALVAGE SYSTEM RS POLYETHYLENE FEMORAL BUSHINGS CATALOG #: 161034 LOT #: 685770, ORTHOPEDIC SALVAGE SYSTEM RS AXLE CATALOG #: 161035 LOT #: 994120, ORTHOPEDIC SALVAGE SYSTEM POLYETHYLENE TIBIAL BUSHING CATALOG #: 150476 LOT #: 604320, ORTHOPEDIC SALVAGE SYSTEM PROXIMAL MODULAR TIBIAL COMPONENT 9CM CATALOG #: CP113461 LOT #: 493800, ORTHOPEDIC SALVAGE SYSTEM DIAPHYSEAL SEGMENT LOCKING SCREW SET CATALOG #: 150481 LOT #: 065760, ORTHOPEDIC SALVAGE SYSTEM POLYETHYLENE LOCKING PIN CATALOG #: 150478 LOT #: 069270, UNKNOWN ORTHOPEDIC SALVAGE SYSTEM RS SEGMENTAL DISTAL FEMUR CATALOG #: NI LOT #: NI.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. D10 - CONCOMITANT DEVICES - ORTHOPEDIC SALVAGE SYSTEM RS LS TIBIAL BEARING 20MM CATALOG #: 161098 LOT #: 967760, ORTHOPEDIC SALVAGE SYSTEM RS POLYETHYLENE FEMORAL BUSHINGS CATALOG #: 161034 LOT #: 685770, ORTHOPEDIC SALVAGE SYSTEM RS AXLE CATALOG #: 161035 LOT #: 994120, UNKNOWN ORTHOPEDIC SALVAGE SYSTEM LOCK PIN CATALOG #: NI LOT #: NI, UNKNOWN ORTHOPEDIC SALVAGE SYSTEM TIBIAL BUSHING CATALOG #: NI LOT #: NI, UNKNOWN ORTHOPEDIC SALVAGE SYSTEM RS SEGMENTAL DISTAL FEMUR CATALOG #: NI LOT #: NI, UNKNOWN ORTHOPEDIC SALVAGE SYSTEM RS NON-MODULAR TIBIA CATALOG #: NI LOT #: NI.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. VISUAL INSPECTION OF THE RETURNED YOKE CONFIRMED THAT BOTH FINS HAD FRACTURED OFF THE DEVICE. ADDITIONAL FRACTURE ANALYSIS OF THE YOKE SHOWED TWO LATERAL FIN FRACTURE SURFACES AND BENDING HINGE ARTIFACTS AT THE OPPOSITE EDGE, INDICATING THE FRACTURE MODE TRANSITIONED FROM FATIGUE TO BENDING OVERLOAD BEFORE FINAL RUPTURE. 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 UNDERWENT A KNEE ARTHROPLASTY REVISION TO ADDRESS POST-OPERATIVE FRACTURE OF THE YOKE, DAMAGE TO THE TIBIAL BEARING, PAIN AND DIFFICULTY AMBULATING APPROXIMATELY ONE (1) YEAR POST-OPERATIVELY. ATTEMPTS HAVE BEEN MADE, HOWEVER, NO ADDITIONAL INFORMATION IS AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A LEFT KNEE ARTHROPLASTY REVISION TO ADDRESS POST-OPERATIVE FRACTURE OF THE YOKE, DAMAGE TO THE TIBIAL BEARING, PAIN AND DIFFICULTY AMBULATING, REQUIRING A CANE APPROXIMATELY ONE (1) YEAR POST-OPERATIVELY. INITIAL OPERATIVE NOTES NOTED THERE WERE NO INTRAOPERATIVE COMPLICATIONS PLACING THE COMPONENTS. REVISION OPERATIVE NOTES NOTED FRONTAL INSTABILITY AND THE TWO LATERAL METAL LOCKING FINS OF THE YOKE WERE BROKEN, WHICH RELEASED THE HINGE AND MADE IT UNSTABLE. THE COMPONENTS WERE REPLACED WITHOUT DIFFICULTY AND NO INTRAOPERATIVE COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A LEFT KNEE ARTHROPLASTY REVISION TO ADDRESS POST-OPERATIVE FRACTURE OF THE YOKE, DAMAGE TO THE TIBIAL BEARING, PAIN AND DIFFICULTY AMBULATING, REQUIRING A CANE APPROXIMATELY ONE (1) YEAR POST-OPERATIVELY. REVISION OPERATIVE NOTES NOTED FRONTAL INSTABILITY AND THE TWO LATERAL METAL LOCKING FINS OF THE YOKE WERE BROKEN, WHICH RELEASED THE HINGE AND MADE IT UNSTABLE. THE COMPONENTS WERE REPLACED WITHOUT DIFFICULTY AND NO INTRAOPERATIVE COMPLICATIONS WERE REPORTED. ATTEMPTS HAVE BEEN MADE, HOWEVER, NO ADDITIONAL INFORMATION IS AVAILABLE.

    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
    998016 ORTHOPEDIC SALVAGE SYSTEM REINFORCED YOKE PROSTHESIS, KNEE KRO ZIMMER BIOMET, INC. N/A 362040 00880304240094

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention| H SEE H10 NARRATIVE.