BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VNGD PS TIB BRG 16X63/67MM

    MDR report key: 10567388 · Received September 22, 2020

    Report

    Report Number
    0001825034-2020-03592
    Event Type
    Injury
    Date Received
    September 22, 2020
    Report Date
    January 21, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    HRY
    PMA / PMN Number
    K023546
    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

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. DEVICES WERE NOT RETURNED BACK FOR EVALUATION. PHOTOGRAPHS PROVIDED SHOW EXPLANTED FEMORAL, TIBIA AND BEARING COMPONENT. THE TIBIAL COMPONENT SHOWS SIGNIFICANT BONE GROWTH ON THE DEVICE. REVIEW OF THE DEVICE HISTORY RECORD(S) IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. NO COMPATIBILITY ISSUES WERE SEEN. REVIEW OF COMPLAINT HISTORY FOR FOUND NO ADDITIONAL RELATED ISSUES FOR THIS ITEM AND THE REPORTED PART AND LOT COMBINATION. MEDICAL RECORDS PROVIDED WERE NOT PROVIDED. X-RAY EVALUATION BY THIRD PARTY HCP CONFIRMS THAT THERE WAS TIBIAL LOOSENING SEEN WITH SUBSIDENCE AND MALPOSITION RESULTING IN KNEE VARUS ALIGNMENT. ABNORMAL RADIOLUCENCY REFLECTING OSTEOLYSIS IS ALSO PRESENT AT THE MEDIAL FEMORAL CONDYLE HOWEVER FEMORAL FIT IS MAINTAINED BUT THE TIBIAL IMPLANT IS LOOSE. OSTEOPENIA WAS ALSO SEEN. ROOT CAUSE CANNOT BE DETERMINED. NO CORRECTIVE ACTIONS, PREVENTIVE ACTIONS, OR FIELD ACTIONS RESULTED AFTER INVESTIGATION OF THIS EVENT. THIS COMPLAINT IS CONFIRMED.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT

    Additional Manufacturer Narrative · 1

    CMP (B)(4).   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. ADDITIONAL MDRS HAVE BEEN SUBMITTED FOR THIS EVENT. --------------------------------------------------------------------- 141222 BIOMET CC I-BEAM TRAY 67MM LOT# J3929490. MDR# 0001825034-2020-03598 . ADDITIONAL ASSOCIATED PRODUCTS ----------------------------------------- 183124 VAN PS OPEN INTL FEM-LT 60 LOT# J3655084, 183099 VANGUARD FEM PEGS SET 2 LOT# 579740, 184764 SERIES A PAT STD 31 3 PEG LOT# 605430.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL KNEE ARTHROPLASTY. DURING THIS SURGERY, AN IMPLANT WAS USED. APPROXIMATELY A MONTH LATE, THE REP WAS NOTIFIED THAT THIS PARTICULAR IMPLANT WAS RECALLED. SUBSEQUENTLY, THE PATIENT IS BEING CONSIDERED FOR A REVISION DUE TO TIBIAL LOOSENING AND SUBSIDENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1032236 VNGD PS TIB BRG 16X63/67MM PROSTHESIS, KNEE HRY ZIMMER BIOMET, INC. N/A 293900

    Patients

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