BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VGXP INTLK FEMORAL LT 67.5

    MDR report key: 13873721 · Received March 24, 2022

    Report

    Report Number
    0001825034-2022-00644
    Event Type
    Injury
    Date Received
    March 24, 2022
    Date of Event
    February 10, 2021
    Report Date
    July 8, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    MBH
    UDI-DI
    00880304580475
    PMA / PMN Number
    K141407
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORT: 0001825034-2022-00645, 0001825034-2022-00666. MEDICAL PRODUCT VGXP XP E1 TIB BRG LL 12X79 ITEM# 195824 LOT# 874780 VGXP AS E1 TIB BRG LM/RL 14X79 ITEM# 195568 LOT# 869170 SERIES A PAT THN 34 3 PEG ITEM# 184786 LOT# 213840 VNGD XP CR INTLK TIB TRAY 79MM ITEM# 195276 LOT# 320590 CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    NO PRODUCT WAS RETURNED, OR PICTURES PROVIDED; THEREFORE, VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. MEDICAL RECORDS/RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. A REVIEW OF THE AVAILABLE RECORDS IDENTIFIED FINDINGS OF THE REPORTED ISSUES, GLOBAL INSTABILITY, AVULSION OF MEDIAL FEMORAL CONDYLE WITH DISRUPTION OF MEDIAL COLLATERAL LIGAMENT, POSTERIOR CRUCIATE LIGAMENT WITH GLOBAL INSTABILITY, INTRA-ARTICULAR SCAR, HYPERTROPHIC SCAR SKIN INCISION. INDICATION FALL WITH PERIPROSTHETIC FRACTURE AS NOTED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED FOR DEVIATIONS AND/ OR ANOMALIES WITH NO RELATED DEVIATIONS / ANOMALIES IDENTIFIED. 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. H6: COMPONENT CODE: PROPOSED COMPONENT (ANNEX G) CODE IS MECHANICAL G4 FEMUR.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT WAS REVISED APPROXIMATELY TWO YEARS SEVEN AND A HALF MONTHS POST IMPLANTATION DUE TO DUE TO INSTABILITY, TISSUE DAMAGE, AND PERIPROSTHETIC FRACTURE CAUSED BY A FALL. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE INFORMATION IS AVAILABLE.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    925349 VGXP INTLK FEMORAL LT 67.5 PROSTHESIS, KNEE MBH ZIMMER BIOMET, INC. N/A 778660 00880304580475

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Hospitalization| R