BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN SMOOTH PEG

    MDR report key: 6997086 · Received November 2, 2017

    Report

    Report Number
    0001825034-2017-09855
    Event Type
    Injury
    Date Received
    November 2, 2017
    Date of Event
    October 5, 2017
    Report Date
    December 7, 2017
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KXE
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MULTIPLE MDRS WERE SUBMITTED FOR THIS EVENT. PLEASE SEE REPORTS: 0001825034 - 2017 - 09851, 0001825034 - 2017 - 09852, 0001825034 - 2017 - 09853, 0001825034 - 2017 - 09854, 0001825034 - 2017 - 09855, 0001825034 - 2017 - 09856, 0001825034 - 2017 - 09857. CONCOMITANT MEDICAL PRODUCTS: DVR ANATOMIC SHORT RIGHT, UNKNOWN PART/LOT, MULTI DIRECTIONAL SCREW, UNKNOWN PART/LOT, QTY: 2, SMOOTH PEG, UNKNOWN PART/LOT, QTY: 4, ULNAR COMPONENT, UNKNOWN PART/LOT. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. NOT RETURNED TO MANUFACTURER.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. X RAYS WERE EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. DHR REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. X-RAY REVIEW CONFIRMED FRACTURE OF THE DISTAL RADIUS; IT WAS FIXED WITH VOLAR PLATE AND SCREWS, AND HAS HEALED WITH MALALIGNMENT OF THE DISTAL FRACTURE FRAGMENT. POSITION OF THE PLATE AND ORIENTATION OF THE SCREWS SUGGESTS MALALIGNMENT OF THE DISTAL RADIUS LIKELY OCCURRED POSTOPERATIVELY, POSSIBLY DUE TO LACK OF ADEQUATE FIXATION OR OTHER ETIOLOGIES SUCH AS TRAUMA. LACK OF FRACTURE FIXATION COULD POSSIBLY BE DUE TO TOO SHORT OF DISTAL RADIUS VOLAR PLATE WITHOUT ADEQUATE PLATING PROXIMAL TO THE FRACTURE SITE. A DISTAL ULNAR ARTHROPLASTY PROSTHESIS IS ALSO PRESENT, THE HEAD OF WHICH ABUTS THE PROXIMAL CORTEX OF THE LUNATE. THERE IS SUBCHONDRAL LUCENCY OF THE PROXIMAL LUNATE, AS WELL AS DIFFUSE SCLEROSIS OF THE LUNATE. 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.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. 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 · 1

    IT WAS REPORTED THE PATIENT WAS REVISED TO ADDRESS IMPLANT FAILURE AND PAIN. BECAUSE OF THE WRIST COLLAPSING, THE ULNAR IMPLANT LEANED MEDIALLY AND WORN INTO THE BONE CAUSING WEAR/GROOVES INTO A COUPLE OF THE PEGS. NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    776041 UNKNOWN SMOOTH PEG PROSTHESIS, EXTREMITY KXE ZIMMER BIOMET, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization| R