HEMICAP PATELLO-FEMORAL RESURFACING PROSTHESIS
Received Nov 16, 2015 · Event occurred Apr 8, 2014
Report 3004154314-2014-00004 · MDR key 5225521
Device
Generic name
Prosthesis, Knee, Patello/femoral, Semi-constrained, Cemented, Metal/polymer
Manufacturer
ArthrosurfaceModel number
PX11-9218/ PX02-0852/ P306-0090Catalog number
PX11-9218/ PX02-0852/P306-0090
Lot number
75CC0617, 75FB1506, 75LJ2217
Product problems
- Insufficient Device Problem Information
Patient
37 YR
- Joint Swelling
- Inadequate Pain Relief
Narrative
Additional Manufacturer Narrative
IT WAS LEARNED THAT THE PATIENT WAS NOT COMPLAINING SPECIFICALLY ABOUT THE HEMICAP PRODUCT BUT RATHER LOOKING FOR OTHER OPTIONS THEY COULD PURSUE INSTEAD OF A TOTAL KNEE IMPLANT. PATIENT HAS HAD 30 PREVIOUS KNEE SURGERIES AND THEREFORE, IT CANNOT BE ASSUMED THAT THE HEMICAP PRODUCT WAS CONTRIBUTING TO THE ISSUE. ARTHROSURFACE, INC'S CLINICAL AND SCIENTIFIC ADVISOR CONTACTED THE PATIENT TO DISCUSS FUTURE OPTIONS FROM THEM, BUT NEVER RECEIVED A RESPONSE. NO FURTHER ACTIONS WILL BE TAKEN AT THIS TIME.
Description of Event or Problem
THE CUSTOMER COMPLAINT RECORD WAS OPENED WHEN THE PATIENT'S SECOND EMAIL CAME IN ON THE (B)(6) 2014. PRIOR TO THIS, NOT ENOUGH INFORMATION WAS AVAILABLE TO DETERMINE IF THE EMAIL WAS A COMPLAINT. THE PATIENT COMPLAINED ABOUT THE POST OPERATIVE COMPLICATIONS THAT SHE WAS HAVING AFTER BEING IMPLANTED WITH HEMICAP PF.