BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COBALT G-HV BONE CEMENT 40G

    MDR report key: 11693597 · Received April 20, 2021

    Report

    Report Number
    0001825034-2021-01088
    Event Type
    Injury
    Date Received
    April 20, 2021
    Date of Event
    May 15, 2017
    Report Date
    August 18, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LOD
    PMA / PMN Number
    K051532
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. A REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED DEVIATIONS OR ANOMALIES DURING MANUFACTURING, THE DEVIATIONS OR ANOMALIES WOULD NOT HAVE ATTRIBUTED TO THE EVENT. MEDICAL RECORDS/RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: RIGHT KNEE REVISION, POLY REMOVED, NO PURULENCE, NO INFECTION. OSTEOTOMES TO BREAK UP CEMENT MANTLE AROUND FEMUR, REMOVED BOTH TIBIA AND FEMORAL COMPONENTS, AND RETAINED PATELLA. NO COMPLICATIONS. A DEFINITIVE ROOT CAUSE CANNOT 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 DEVICES: ITEM# 183053 / ITEM NAME VANGUARD CR POR FEM-RT 72.5 / LOT#813000; ITEM# 141224 / ITEM NAME BIOMET CC I-BEAM TRAY 75MM / LOT#J3252831; ITEM# 183440 / ITEM NAME VNGD CR TIB BRG 10X71/75 / LOT#447810. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS LOCATION UNKNOWN; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY LEGAL PRIMARY RIGHT TKA PERFORMED. SUBSEQUENTLY IT WAS REPORTED RIGHT REVISION OF TOTAL KNEE 2 YEARS LATER DUE TO PAIN, LOOSENING AND INSTABILITY. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    595339 COBALT G-HV BONE CEMENT 40G CEMENT, BONE CEMENT LOD ZIMMER BIOMET, INC. N/A 859830

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R SEE H10 NARRATIVE