VANGUARD POSTERIOR STABILIZED BOX CHISEL
Received Oct 22, 2025 · Event occurred Sep 30, 2025
Report 0001825034-2025-03293 · MDR key 23358597
Device
Product problems
- Fracture
- Fracture
Patient
NA · Male
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
(B)(4). THE COMPLAINANT HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.
Description of Event or Problem
IT WAS REPORTED DURING KNEE ARTHROPLASTY THAT THE BOX CHISEL FRACTURED IN HALF UPON COMPLETION OF USE. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION.
Additional Manufacturer Narrative
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, G3, G6, H2, H3, H6, H11. THE FOLLOWING SECTIONS WERE CORRECTED: D4 (EXPIRATION DATE WAS POPULATED ERRONEOUSLY ON PREVIOUS SUBMISSION). THE PRODUCT WAS EVALUATED THROUGH MANUFACTURING REVIEW, HOWEVER, THE REPORTED EVENT COULD NOT BE CONFIRMED. THE DEVICE HISTORY RECORDS WERE REVIEWED AND NO DISCREPANCIES WERE IDENTIFIED. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED WITH THE INFORMATION PROVIDED. 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
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.