BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CABLE CERCLAGE CABLE WITH CRIMP 1.8 MM DIA. 635 MM LENGTH

    MDR report key: 7886715 · Received September 18, 2018

    Report

    Report Number
    0001822565-2018-05058
    Event Type
    Injury
    Date Received
    September 18, 2018
    Report Date
    February 7, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KTT
    PMA / PMN Number
    PK151907
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT WAS CONFIRMED BY REVIEW OF MEDICAL RECORDS. PHYSICAL THERAPY REPORT NOTED PAIN AND ROM NOTED POSTOPERATIVELY. REVIEW OF DEVICE HISTORY RECORDS FOUND THESE UNITS WERE RELEASED TO DISTRIBUTION WITH NO DEVIATIONS OR ANOMALIES. ROOT CAUSE COULD NOT BE DETERMINED. 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- VNGD SSK PS TIB BRG 10X71/75 CATALOG#:185080 LOT#:034860, BMT 360 2.5MM OFFSET ADAPTER CATALOG#:185210 LOT#:759770, BMT 360 TIB SM CRUCIATE WING CATALOG#:185650 LOT#:725770, BMT 360 TIB TRAY 71MM CATALOG#:185203 LOT#:937920, BMT 360 TIB AUG 71X10MM CATALOG#:185233 LOT#:602330, VG 360 UNIV PST FM AUG 67.5X5 CATALOG#:185345 LOT#:190200, VNGD SSK 360 FEMUR L 67.5 CATALOG#:185285 LOT#:3357685, BMT SPLINED KNEE STM V2 17X40 CATALOG#:148292 LOT#:979960, VG 360 DST FM AG 67.5X15 LL/RM CATALOG#:185485 LOT#:761910, BMT 360 TIB AUG 71X10MM CATALOG#:185233 LOT#:115500, VG 360 DST FM AG 67.5X5 RL/LM CATALOG#:185305 LOT#:661740, BMT SPLINED KNEE STM V2 18X120 CATALOG#:148321 LOT#:070920, VG 360 DST FM AG 67.5X5 LL/RM CATALOG#:185325 LOT#:577550. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS IT REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT LEFT REVISION KNEE ARTHROPLASTY, AND SUBSEQUENTLY IS EXPERIENCING PAIN. ACTIVITIES OF DAILY LIVING ARE EFFECTED BY THE PAIN AND AMBULATION IS REPORTED TO BE DIFFICULT. PATIENT REPORTEDLY EXPERIENCED NERVE DAMAGE AFTER THE PROCEDURE AS WELL, HOWEVER THIS WAS REPORTED TO HAVE RESOLVED. NO ADDITIONAL INFORMATION HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    724985 CABLE CERCLAGE CABLE WITH CRIMP 1.8 MM DIA. 635 MM LENGTH APPLIANCE, FIXATION KTT ZIMMER BIOMET, INC. N/A 63222752

    Patients

    Seq Age Sex Outcome Treatment
    1 Other