BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRANSDERMAL CPS FAILSAFE

    MDR report key: 7742502 · Received August 2, 2018

    Report

    Report Number
    0001825034-2018-05447
    Event Type
    Injury
    Date Received
    August 2, 2018
    Report Date
    January 29, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    PEXEMPT
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    FINALTHIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY UPDATED AND ADDITIONAL INFORMATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2018 - 05446 - 2, 0001825034 - 2019 - 00026 - 1.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PATIENT WAS IN A SEVERE ACCIDENT IN 2014 WHILE RIDING A RECLINED BIKE WHICH RESULTED IN HIS LEG AMPUTATION. SUBSEQUENTLY, THE PATIENT IS EXPERIENCING WOBBLE BETWEEN THE ABUTMENT AND THE LOWER PROSTHETIC KNEE DURING GAIT. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4). (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, BECAUSE IT REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS AND ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORT(S): 0001825034 - 2018 - 05446, 0001825034 - 2018 - 05447. REMAINS IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT UNDERWENT A KNEE REVISION 12 MONTHS POST-IMPLANTATION. SUBSEQUENTLY, THE PATIENT IS EXPERIENCING WOBBLE BETWEEN THE ABUTMENT AND THE LOWER PROSTHETIC KNEE DURING GAIT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    583498 TRANSDERMAL CPS FAILSAFE PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 229320

    Patients

    Seq Age Sex Outcome Treatment
    1 Other