VANGUARD PFR FEMORAL RT SM
Received Sep 26, 2014 · Event occurred Aug 20, 2007
Report 0001825034-2014-07886 · MDR key 4122211
Device
Generic name
Prosthesis, Knee
Manufacturer
Biomet OrthopedicsModel number
N/ACatalog number
11-150906
Lot number
026883
Product problems
- Loose or Intermittent Connection
Patient
Not reported
- No Code Available
Narrative
Description of Event or Problem
IT WAS REPORTED PATIENT UNDERWENT A RIGHT KNEE REVISION PROCEDURE ON (B)(6) 2007 DUE TO AN UNKNOWN REASON. ALL COMPONENTS WERE REMOVED AND REPLACED WITH A TOTAL KNEE SYSTEM. SUBSEQUENTLY, A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2014 DUE TO TIBIAL LOOSENING. THE TIBIAL TRAY AND FEMORAL COMPONENT WERE REMOVED AND REPLACED. ADDITIONAL INFORMATION RECEIVED NOTED PATIENT UNDERWENT A BILATERAL PATELLOFEMORAL PARTIAL KNEE ARTHROPLASTY ON (B)(6) 2005.
Additional Manufacturer Narrative
CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. THIS REPORT IS NUMBER 2 OF 2 MDRS FILED FOR THE SAME PATIENT (REFERENCE 1825034-2014- 06305 & 07886).