VG 360 5N1 LK TIB TRL 79/83X10
Received Jun 7, 2021 · Event occurred May 11, 2021
Report 0001825034-2021-01713 · MDR key 11945920
Device
Generic name
Prosthesis Knee
Manufacturer
Zimmer Biomet, Inc.Model number
N/ACatalog number
32-360560
Lot number
352630
Product problems
- Fracture
- Fracture
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
(B)(4). REPORT SOURCE: (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED BECAUSE PRODUCT LOCATION IS UNKNOWN. REPORTED EVENT WAS CONFIRMED BY REVIEW OF PICTURES PROVIDED. VISUAL EVALUATION OF THE DEVICE PICTURES SHOWS SIGNS OF REPEATED USE AND A PIECE HAS FRACTURED OFF. DEVICE WAS NOT RETURNED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. 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.
Description of Event or Problem
IT WAS REPORTED THAT THE DEVICE WAS FRACTURED DURING TRIALING. THE KNEE WAS VERY TIGHT AND THE DEVICE FRACTURED WHILE THE SURGEON WAS TRYING TO REMOVE IT FROM THE PATIENT. ATTEMPT FOR FURTHER INFORMATION HAS BEEN MADE, BUT NO FURTHER INFORMATION HAS BEEN PROVIDED.