MAUDE Adverse Event Report: ARTHROSURFACE UNICAP UNICOMPARTMENTAL KNEE RESURFACING PROSTHESIS; PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number U202-0631-W/ U205-0505-W/ U110-0218-W

Device Problem Insufficient Information (3190)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/09/2013

Event Type  No Answer Provided  

Manufacturer Narrative

Limited information is available to conclusively evaluate the event occurence.The implanting surgeon had no evidence to suggest that the implant components had loosened.The patient had converted to a total knee implant uneventfully at 6 months post initial surgery.No further information was available.Attempts to follow-up with the patient and her husband have been made with no response received.

Event Description

Patient's husband contacted arthrosurface to inform that the patient did not receive pain relief as desired and was of the opinion that the implant had loosened, albeit without any radiographic or other diagnostic proof of the same.This mdr (fda medwatch form 3500a) is now being filed in accordance with the findings on form (b)(4), received during our fda inspection held in (b)(6) 2015.

• Brand Name: UNICAP UNICOMPARTMENTAL KNEE RESURFACING PROSTHESIS
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, NON-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: 5225438
• MDR Text Key: 31316973
• Report Number: 3004154314-2013-00004
• Device Sequence Number: 1
• Product Code: HSX
• Combination Product (y/n): N
• PMA/PMN Number: K050373
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient Family Member or Friend
• 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?: Yes
• Device Operator: Physician
• Device Model Number: U202-0631-W/ U205-0505-W/ U110-0218-W
• Device Catalogue Number: U202-0631-W/ U205-0505-W/ U110
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• 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; Required Intervention
• Patient Age: 53 YR