BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTICULAR SURFACE MEDIAL CONGRUENT (MC) RIGHT 10 MM HEIGHT USE WITH TIBIA

    MDR report key: 15348129 · Received September 2, 2022

    Report

    Report Number
    3007963827-2022-00225
    Event Type
    Injury
    Date Received
    September 2, 2022
    Date of Event
    July 25, 2022
    Report Date
    February 13, 2023
    Manufacturer
    ZIMMER ORTHOPAEDIC MFG. LTD.
    Product Code
    MBH
    UDI-DI
    00889024468412
    PMA / PMN Number
    K150090
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). PERIPHERAL NERVE INJURY OR DISEASE CAN CAUSE SYMPTOMS OF PAIN, BURNING, DYSESTHESIAS, AND EITHER PARTIAL OR COMPLETE LOSS OF SENSORY AND MOTOR FUNCTION. FOOT DROP CAN BE CAUSED BY NERVE DAMAGE DURING THE ARTHROPLASTY PROCEDURE. IF PROCEDURAL NERVE DAMAGE IS DONE, THIS CAUSES NERVE PALSY AND THE INABILITY TO LIFT THE FOOT. FOOT DROP CAN ALSO BE CAUSED THE PATIENTS COMORBIDITIES, I.E. LIMITED MOBILITY, PARKINSON¿S, CVAS WITH PARALYSIS, OR SCIATIC/PINCHED NERVE. AS POSTOPERATIVE DEVELOPMENT OF FOOT DROP DEVELOPS WITH NO OTHER IDENTIFIED CAUSE, THIS SIGNIFIES A POSTOPERATIVE COMPLICATION. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 3007963827-2022-00223, 3007963827-2022-00224, 0002648920-2022-00184, 0001822565-2022-02429.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4; B5; G3; G6; H1; H2; H10 THE ADDITIONAL INFORMATION RECEIVED DOES NOT ALTER THE INVESTIGATION. THE ROOT CAUSE REMAINS THE SAME. 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

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A RIGHT TOTAL KNEE ARTHROPLASTY. APPROXIMATELY 5 DAYS POST IMPLANTATION, THE PATIENT DEVELOPED RIGHT FOOT DROP AND WAS PRESCRIBED PHYSICAL THERAPY AND AN ANKLE FOOT ORTHOSIS BRACE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A RIGHT TOTAL KNEE ARTHROPLASTY. APPROXIMATELY 5 DAYS POST IMPLANTATION, THE PATIENT DEVELOPED RIGHT FOOT DROP AND WAS PRESCRIBED PHYSICAL THERAPY AND AN ANKLE FOOT ORTHOSIS BRACE. THREE MONTHS LATER, THE PATIENT HAD AN ELECTROMYOGRAPHY NERVE STUDY IN WHICH THE PATIENT TOLERATED THE INTERVENTION. NO FURTHER COMPLICATIONS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1640258 ARTICULAR SURFACE MEDIAL CONGRUENT (MC) RIGHT 10 MM HEIGHT USE WITH TIBIA PROSTHESIS, KNEE MBH ZIMMER ORTHOPAEDIC MFG. LTD. N/A 65336388 00889024468412

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other