BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VNGD SSK 360 R FEM 75MM

    MDR report key: 21431868 · Received February 21, 2025

    Report

    Report Number
    0001825034-2025-00410
    Event Type
    Injury
    Date Received
    February 21, 2025
    Date of Event
    January 8, 2024
    Report Date
    July 31, 2025
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    K093293
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10-MEDICAL PRODUCT BMT SMOOTH KNEE STEM 18X80 ITEM# 145028, LOT# 136580. VG 360 DST FM AG 75X5 LL/RM ITEM# 185328, LOT# 765410. VG 360 DST FM AG 75X10 RL/LM ITEM# 185388, LOT# 966850. VG 360 UNIV PST FM AUG 75X5 ITEM# 185348, LOT# 665610. BMT 360 TIB TRAY 71MM ITEM# 185203, LOT# 925800. BIOMET SMOOTH KNEE STEMS 14X40 ITEM# 145004, LOT# 608190. G2- UNITED KINGDOM. H3- 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

    THIS FOLLOW-UP IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. UPDATED: A2, B4, B5, B7, D2, G1, G3, G6, H1, H2, AND H11 A2- PATIENT WAS BORN IN 1934.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION. UPDATED: B4, B5, D2, D4, G1, G3, G6, H1, H2, H3, H4, H6, AND H11. NO PRODUCT OR PHOTOS WERE RETURNED; THEREFORE, VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. REVIEW OF PRIMARY NOTES STATE NO INTRA OPERATIVE COMPLICATIONS. POST OP PATIENT WAS DETECTED WITH BREAST CANCER AND WAS EXPERIENCING PAIN, SWELLING, AND DIFFICULTY WALKING. THE PATIENT FELL AND EXPERIENCED A FEMORAL HEAD FRACTURE AND LATER EXPERIENCED A SECOND FALL AND THEN HAD TO UNDERGO AMPUTATION. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO RELATED DEVIATIONS OR ANOMALIES DURING MANUFACTURING. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. THIS COMPLAINT IS CONFIRMED VIA THE PROVIDED MEDICAL NOTES. 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. PROPOSED ANNEX G CODE: MECHANICAL (G04): FEMUR.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT'S LEG WAS AMPUTATED ABOVE THE RIGHT KNEE APPROXIMATELY NINE AND A HALF YEARS POST IMPLANTATION DUE TO INJURIES SUSTAINED IN A FALL RESULTING IN A FRACTURE OF THE RIGHT FEMUR. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE INFORMATION IS AVAILABLE AT THIS TIME.

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1045017 VNGD SSK 360 R FEM 75MM PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. 2794979

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Female Hospitalization| R SEE H11