MAUDE Adverse Event Report: ARTHROSURFACE HEMICAP PATELLO-FEMORAL RESURFACING PROSTHESIS; PROSTHESIS, KNEE, PATELLO/FEMORAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number PX11-9218/ PX02-0852/ P306-0090

Device Problem Insufficient Information (3190)

Patient Problems Joint Swelling (2356); Inadequate Pain Relief (2388)

Event Date 04/08/2014

Event Type  No Answer Provided  

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.

Event Description

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.

• Brand Name: HEMICAP PATELLO-FEMORAL RESURFACING PROSTHESIS
• Type of Device: PROSTHESIS, KNEE, PATELLO/FEMORAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): ARTHROSURFACE; 28 forge parkway; franklin MA 02038
• Manufacturer (Section G): ARTHROSURFACE; 28 forge parkway; franklin MA 02038
• Manufacturer Contact: phani puppala ; 28 forge parkway; franklin, MA 02038 ; 5085203003
• MDR Report Key: 5225521
• MDR Text Key: 31252578
• Report Number: 3004154314-2014-00004
• Device Sequence Number: 1
• Product Code: KRR
• Combination Product (y/n): N
• PMA/PMN Number: K060127
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 10/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: PX11-9218/ PX02-0852/ P306-0090
• Device Catalogue Number: PX11-9218/ PX02-0852/P306-0090
• Device Lot Number: 75CC0617, 75FB1506, 75LJ2217
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/08/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 37 YR