BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD CR POR FEM-RT 62.5

    MDR report key: 10816875 · Received November 10, 2020

    Report

    Report Number
    0001825034-2020-04056
    Event Type
    Injury
    Date Received
    November 10, 2020
    Report Date
    November 25, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    UDI-DI
    00880304270602
    PMA / PMN Number
    K113550
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED B3: EVENT DATE (B)(6) 2016 D7: EXPLANT DATE (B)(6) 2016 IT WAS REPORTED BY THE PATIENT THAT THE SURGEON CUT A NERVE ON THE INTERIOR OF THE KNEE WHILE REMOVING IMPLANTS. THERE ARE NO ALLEGATIONS AGAINST THE DEVICES IN RELATION TO THIS EVENT. PROCEDURAL RELATED COMPLICATIONS ARE INFLUENCED BY THE TYPE OF SURGERY, PATIENTS PRE-EXISTING COMORBID STATE, AND PERIOPERATIVE MANAGEMENT. SURGICAL PROCEDURES HAVE A KNOW INHERIT RISK ASSOCIATED WITH POTENTIAL FOR NERVE INJURY. DEPENDING ON THE SEVERITY OF NERVE DAMAGE, PATIENT CAN EXPERIENCE A WIDE RANGE OF SIGNS AND SYMPTOMS. NERVE INJURY OR DISEASE CAN CAUSE SYMPTOMS OF PAIN, BURNING, DYSESTHESIAS, AND EITHER PARTIAL OR COMPLETE LOSS OF SENSORY AND MOTOR FUNCTION. PARALYSIS IS A CONDITION RELATED TO NERVE DAMAGE. THERE ARE MANY OTHER CAUSES THAT CAN ALSO CAUSE PARALYSIS IN ADDITION TO ACCIDENTAL CUTTING OF A NERVE SUCH AS, STROKE, TRAUMA WITH NERVE INJURY, POLIOMYELITIS, CEREBRAL PALSY, PERIPHERAL NEUROPATHY, PARKINSON'S DISEASE, ALS, BOTULISM, SPINA BIFIDA, MULTIPLE SCLEROSIS, AND GUILLAIN¿BARRÉ SYNDROME. PARALYSIS IS THE LOSS OF MUSCLE FUNCTION IN PART OF YOUR BODY. PARALYSIS CAN BE COMPLETE OR PARTIAL. IT CAN OCCUR ON ONE OR BOTH SIDES OF YOUR BODY. 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 PRODUCTS: EVENT DATE - (B)(6) 2016, 189022 - BEARING - 915660, 141271 - TIBIAL TRAY - 889640, 141369 - STEM - 568190. THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE PRODUCT LOCATION IS UNKNOWN. 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 EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2020-04057, 0001825034-2020-04059, 0001825034-2020-04060.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL KNEE ARTHROPLASTY. APPROXIMATELY 10 MONTHS POST IMPLANTATION, THE PATIENT UNDERWENT A REVISION PROCEDURE WHERE ALL DEVICES WERE REMOVED AND PATIENT WAS WITHOUT HARDWARE FOR APPROXIMATELY ONE YEAR TO CLEAR INFECTION. DURING THE REMOVAL OF IMPLANTS, THE PATIENT ALLEGES THE SURGEON CUT A NERVE ON THE INTERIOR OF HER KNEE AND SHE IS NOW PARALYZED FROM THE KNEE DOWN TO HER TOES AND HAS CRPS. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1284277 VANGUARD CR POR FEM-RT 62.5 PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 661180 00880304270602

    Patients

    Seq Age Sex Outcome Treatment
    1 Other SEE H10.