HEMICAP PATELLO-FEMORAL RESURFACING PROSTHESIS
Received Dec 10, 2015 · Event occurred Nov 13, 2015
Report 3004154314-2015-00008 · MDR key 5285542
Device
Generic name
Prosthesis, Knee, Patello/femoral, Semi-constrained, Cemented, Metal/polymer
Manufacturer
Arthrosurface, Inc.Catalog number
P085-0017-W/ P202-3020-W
Lot number
75HB1618/ 75LB1807
Product problems
- Unstable
Patient
Not reported
- Inadequate Pain Relief
Narrative
Additional Manufacturer Narrative
DURING PATIENT'S LATEST VISIT TO THE TREATING SURGEON, IT WAS FOUND THAT THERE WAS A THICK LAYER OF SCAR TISSUE IN PATIENT'S KNEE IMPEDING THE HEMICAP COMPONENTS FROM ARTICULATION. SINCE SCAR TISSUE IS NOW REMOVED, THE PATIENT IS HAVING GOOD RANGE OF MOTION AND IS FEELING COMFORTABLE WITH THE IMPLANT. NO OTHER ISSUES WERE REPORTED REGARDING THE FUNCTIONALITY OF THE IMPLANT. FOLLOWING ARE THE DETAILS OF COMPONENTS IMPLANTED IN THE PATIENT: PART # P085-0017-W, LOT # 75HB1618, MFG DATE: 2012-08, EXP DATE: 2017-08; PART # P202-3020-W, LOT # 75LB1807, MFG DATE: 2012-12, EXP DATE: 2019-12. THE COMPLAINT IS CONSIDERED CLOSED AT THIS TIME. SHOULD THERE BE ANY ISSUES OR UPDATES, A SUPPLEMENTAL MDR WILL BE FILED ACCORDINGLY.
Description of Event or Problem
PATIENT CONTACTED ARTHROSURFACE TO REPORT CHRONIC PAIN IN THE KNEE JOINT IMPLANTED WITH PF HEMICAP IN (B)(6) 2015. THE PATIENT IS UNCOMFORTABLE WITH THE IMPLANT AND FEELS THAT THE KNEE IS POPPING OUT OF THE PLACE.