HEMICAP PATELLO-FEMORAL RESURFACING PROSTHESIS
Received Aug 22, 2017 · Event occurred May 12, 2017
Report 3004154314-2017-00012 · MDR key 6810713
Device
Generic name
Knee Joint Patello-femoral Resurfacing Prosthesis
Manufacturer
Arthrosurface, Inc.Product problems
- Appropriate Device Problem Term/Code Not Available
Patient
Not reported
- Inadequate Pain Relief
- Inadequate Pain Relief
Narrative
Additional Manufacturer Narrative
ARTHROSURFACE HAS LIMITED INFORMATION REGARDING THIS CASE FROM THE SOURCE DOCUMENT RECEIVED. SINCE THE DEVICE WAS NOT RECEIVED FOR EVALUATION, REPORTED WEAR ON THE DEVICE (PATELLA CHUNK) COULD NOT BE CONFIRMED. AS NO PART NUMBER AND LOT NUMBER WERE PROVIDED, THE MANUFACTURING HISTORY OF THE IMPLANT DEVICE(S) INSTALLED IN THE PATIENT COULD NOT BE REVIEWED. THE REASONS FOR WORN PATELLA OR PAIN COULD NOT BE ASCERTAINED DUE TO LIMITED INFORMATION. ADDITIONAL INFORMATION PERTAINING TO DEVICES REMOVED FROM THE PATIENT WAS REQUESTED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL MDR WILL BE SUBMITTED.
Description of Event or Problem
ARTHROSURFACE WAS NOTIFIED OF THE INFORMATION THAT A PATIENT IMPLANTED WITH HEMICAP PFXL IMPLANT WAS REVISED DUE TO PAIN. THE SURGEON NOTED A PATELLA CHUNK AT THE TIME OF REVISION SURGERY.