MAUDE Adverse Event Report: ARTHREX, INC. IBALANCE TKA,BEARING IMPLANT,PS,SZ 5, 8MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	AR-513-BF08
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	11/16/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient demographics (age at time of event, date of birth, weight) were requested but not provided.This is the third of three submissions for the same patient event.The others are 1220246-2016-00551 ((b)(4) (b)(6)) and 1220246-2016-00552 ((b)(4) (b)(6)).No further patient information was provided at the time of this report or made available in response to follow-up communication.No additional adverse consequences have been reported from this event.This device is used for treatment.No further patient information was provided at the time of this report or made available in response to arthrex's follow-up requests.The device was not returned for evaluation and the contribution of the device to the reported event could not be determined.The information received regarding the event is not sufficient to determine the cause of the event.A dhr review for this catalog number, ar-513-bg10 and lot number 113601341 combination found no related information.If additional relevant information is received, a follow-up report will be submitted.Device in patient's possession.
Event or Problem Description
It was reported that on (b)(6) 2015 the patient underwent a left tka procedure during which arthrex ibalance tka devices were implanted.On (b)(6) 2015, while at physical therapy, the patient's therapist noticed that the knee was not correcting.On (b)(6) 2015, the patient went to see the original surgeon who recommended either a lateral release or a total revision surgery to correct the knee.On (b)(6) 2016 patient was seen by a new surgeon for a second opinion and a left tka revision surgery was performed on (b)(6) 2016 by the new surgeon at a different facility than the original surgery facility.Patient reports that the following arthrex devices were explanted during the revision surgery: ar-503-tttf, ibalance size 5 tibial tray, lot: 108761211 ((b)(4) (b)(6)), ar-516-5l, femoral implant, lot 1373716 ((b)(4) (b)(6)) and ar-513-bg10, bearing implant, lot 113601341 ((b)(4) (b)(6)).The original arthrex patella implant was left in the patient and another manufacturer's product was used to complete the tka revision.The patient requested and has kept the explanted arthrex devices.
Additional Manufacturer Narrative
Patient demographics (age at time of event, date of birth, weight) were requested but not provided.This is a follow-up submission to update the part number and date of the original surgery (scrub sheet from original surgery has been obtained.Correct date of surgery was (b)(6) 2015, not (b)(6) 2015 as originally entered in the file.Bearing implant has been confirmed to be ar-513-bf08, not ar-513-bg10 as originally entered in the file) this is the third of three submissions for the same patient event.The others are 1220246-2016-00551 ((b)(4)) and 1220246-2016-00552 ((b)(4)).No further patient information was provided at the time of this report or made available in response to follow-up communication.No additional adverse consequences have been reported from this event.This device is used for treatment.No further patient information was provided at the time of this report or made available in response to arthrex's follow-up requests.The device was not returned for evaluation and the contribution of the device to the reported event could not be determined.The information received regarding the event is not sufficient to determine the cause of the event.A dhr review for this catalog number, ar-513-bg10 and lot number 113601341 combination found no related information.If additional relevant information is received, a follow-up report will be submitted.Device in patient's possession.
Event or Problem Description
It was reported that on (b)(6) 2015 the patient underwent a left tka procedure during which arthrex ibalance tka devices were implanted.On (b)(6) 2015, while at physical therapy, the patient's therapist noticed that the knee was not correcting.On (b)(6) 2015, the patient went to see the original surgeon who recommended either a lateral release or a total revision surgery to correct the knee.On (b)(6) 2016 patient was seen by a new surgeon for a second opinion and a left tka revision surgery was performed on (b)(6) 2016 by the new surgeon at a different facility than the original surgery facility.Patient reports that the following arthrex devices were explanted during the revision surgery: ar-503-tttf, ibalance size 5 tibial tray, lot: 108761211 ((b)(4)), ar-516-5l, femoral implant, lot 1373716 ((b)(4)) and ar-513-bg10, bearing implant, lot 113601341 ((b)(4)).The original arthrex patella implant was left in the patient and another manufacturer's product was used to complete the tka revision.The patient requested and has kept the explanted arthrex devices.Follow-up investigation/additional information: surgical scrub sheet from original surgery has been obtained.Correct date of surgery was (b)(6) 2015, not (b)(6) 2015 as originally entered in the file.Bearing implant has been confirmed to be ar-513-bf08, not ar-513-bg10 as originally entered in the file.

• Brand Name: IBALANCE TKA,BEARING IMPLANT,PS,SZ 5, 8MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 6157544
• Report Number: 1220246-2016-00553
• Device Sequence Number: 783807
• Product Code: JWH
• UDI-Device Identifier: 00888867107458
• UDI-Public: 00888867107458
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K081127
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date (Section B): 12/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 12/01/2018
• Device Catalogue Number: AR-513-BF08
• Device Lot Number: 113601341
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 11/16/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/09/2016
• Supplement Report FDA Received Date: 12/29/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other