VAN PS OPEN INTL FEM-RT 62.5
Received Jan 20, 2020 · Event occurred Dec 8, 2015
Report 0001825034-2020-00308 · MDR key 9607977
Device
Generic name
Prosthesis, Knee
Manufacturer
Zimmer Biomet, Inc.Model number
183106Catalog number
183106
Lot number
882840
Product problems
- Loss of or Failure to Bond
- Malposition of Device
- Loss of or Failure to Bond
- Malposition of Device
Patient
Not reported
- Failure of Implant
- Reaction
- Failure of Implant
- Reaction
Narrative
Additional Manufacturer Narrative
(B)(4). MULTIPLE MDR'S ARE ASSOCIATED WITH THIS REPORTING. PLEASE ALSO REFERENCE: 1825034-2016-01524. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP/FINAL REPORT WILL BE SUBMITTED. NOT RETURNED TO MANUFACTURER.
Description of Event or Problem
IT WAS REPORTED THE PATIENT WAS REVISED DUE TO CEMENT LOOSENING CAUSING DEVICE MALPOSITION AND ALLERGIC REACTION. IT SHOULD BE NOTED THE CEMENT IS A COMPETITOR DEVICE. NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE AT THIS TIME.
Additional Manufacturer Narrative
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. UPDATED: H2, H3, H6, H10. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. REVIEW OF THE DEVICE HISTORY RECORD IDENTIFIED NO RELATED DEVIATIONS OR ANOMALIES DURING MANUFACTURING. LAB REPORTS PROVIDED FOR INFLAMMATION PRE-REVISION AND ANTICOAGULATION MONITORING POST-REVISION. 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
NO FURTHER INFORMATION AVAILABLE AT THE TIME OF THIS REPORTING.