BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD SERIES A PAT W/WR STD 28 1 PEG

    MDR report key: 23537496 · Received November 12, 2025

    Report

    Report Number
    0001825034-2025-03591
    Event Type
    Injury
    Date Received
    November 12, 2025
    Date of Event
    April 29, 2024
    Report Date
    April 28, 2026
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    UDI-DI
    00887868343964
    PMA / PMN Number
    K171054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10: MEDICAL PRODUCT: VANGUARD CR POR FEM-RT 65: CATALOG# 183048, LOT #900670; BIOMET CC CRUCIATE TRAY 67MM: CATALOG# 141232, LOT# J7510816; VGD VE AS TIB BRG 67X10MM: CATALOG# VE189040, LOT# 65268828. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4; B5; G3; H2; H3; H6; H10; H11. VISUAL AND DIMENSIONAL EVALUATIONS OF THE PRODUCT COULD NOT BE PERFORMED AS NO PRODUCT WAS RETURNED NOR WERE PICTURES PROVIDED. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELATED TO THE REPORTED EVENT WERE FOUND. OFFICE VISIT POST INITIAL SURGERY PROVIDED STATES THAT PATIENT WAS EXPERIENCING RIGHT KNEE PAIN (ACHY/BURNING WITH NUMBNESS, TINGLING), SWELLING, DIFFICULTY AMBULATING AND THE KNEE WAS NEVER FULLY EXTENDED. A BAKER'S CYST WAS IDENTIFIED POST-SURGERY. THE PATIENT TRIED TO STAND UP ON THE BEACH BUT FELT SEVERE PAIN WITH LOUD NOISE FROM THE KNEE. SUBSEQUENTLY THE PATIENT FEELS PAIN WITH PROLONGED WALKING, EXPERIENCED SIGNIFICANT SWELLING POST-SURGERY, WHICH EXTENDED INTO HER ABDOMEN AND HIP. PATIENT ALSO DEVELOPED A RIGHT FOOT DROP, ATTRIBUTED TO NERVE DAMAGE, AND ALSO HAD RIGHT PERONEAL NEUROPATHY WHICH IS LOCATED AT THE LEVEL OF THE KNEE WITH DEEP INJURY TO THE DEEP PERONEAL NERVE. PATIENT ALSO REPORTS A LACK OF MOTION IN THE FOOT, WHICH PREVENTS STANDING UP. X-RAYS SHOW KNEE WITH EXCESSIVE TIBIAL SLOPE. PATIENT UNDERWENT MANIPULATION UNDER ANESTHESIA DUE TO FOOT DROP FROM PERONEAL NERVE PALSY AND ARTHROFIBROSIS. REPORTED EVENT WAS CONFIRMED BY REVIEW OF PROVIDED MEDICAL RECORDS. REGARDING THE PAIN, LIMITED RANGE OF MOTION, SWELLING, NERVE DAMAGE, AND NOISE, A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. REGARDING THE BAKER'S CYST, INVESTIGATION RESULTS CONCLUDED THAT THE ROOT CAUSE OF THE REPORTED EVENT IS UNRELATED TO THE DEVICE. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL RIGHT TOTAL KNEE ARTHROPLASTY. FOLLOWING THE PROCEDURE, THE PATIENT CONTINUED HAVING PAIN AND NEUROPATHY IN THE LEG WITH LIMITED RANGE OF MOTION. DIAGNOSTICS REVEALED DAMAGE TO THE PERONEAL NERVE RESULTING IN FOOT DROP AND DIFFICULTY AMBULATING. PHYSICAL EXAM REVEALED A PALPABLE BAKER¿S CYST, AND X-RAYS SHOWED EXCESSIVE TIBIAL SLOPE. SUBSEQUENTLY, APPROXIMATELY FOUR (4) MONTHS POST-IMPLANTATION, A MANIPULATION UNDER ANESTHESIA WAS PERFORMED DUE TO ANKYLOSIS AND ARTHROFIBROSIS. ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AT TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2034230 VANGUARD SERIES A PAT W/WR STD 28 1 PEG PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. 65783328 00887868343964

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention| H