InjuryHTG
UNKNOWN X3 ASSYMETRIC PATELLA
Received Jun 15, 2011 · Event occurred May 16, 2011
Report 2249697-2011-00885 · MDR key 2134890
Device
Generic name
Implant
Manufacturer
Stryker Orthopaedics MahwahModel number
NACatalog number
UNK
Lot number
UNK
Product problems
- Material Discolored
- Device Slipped
- Naturally Worn
Patient
UNK
- Pain
Narrative
Description of Event or Problem
IT WAS REPORTED THAT, "PT COMPLAINING OF ANTERIOR KNEE PAIN AND LAXITY. DR REVISED KNEE TO ADDRESS THIS. ON REMOVAL OF INSERT AND PATELLA, OXIDATION OF POLY WAS NOTED. NO MAJOR WEAR, BUT YELLOWING OF POLY HAD OCCURRED."
Additional Manufacturer Narrative
AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. THIS IS THE SAME PATIENT/EVENT AS MFR # 9610726-2011-00213.
Remedial action
- Other