MAUDE Adverse Event Report: ARTHREX, INC. IBALANCE TKA TIBIAL TRAY SIZE 4; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	AR-503-TTTE
Health Effect - Clinical Codes	Pain (1994); Joint Swelling (2356)
Date of Event	07/11/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No further patient information was provided at the time of this report or made available in response to arthrex's follow-up requests.This is the first of two submissions from the same patient event.The other is line (b)(6) (1220246-2016-00317).The device was not returned for evaluation and the contribution of the device to the reported event could not be determined.The catalog number ar-503-ttte and lot number 1297366 associated with this event has been involved in recall number 1220246-1/29/16-001-r.The information received regarding the event is not sufficient to determine the cause of the event or whether it had any relation to the recall.If additional relevant information is received, a follow-up report will be submitted.Device being returned.Not yet received.
Event or Problem Description
It was reported that on (b)(6) 2015, patient underwent a left tka procedure.On (b)(6) 2016 surgeon performed a revision left tka due to patient pain.During the revision procedure, the surgeon explanted the tibial tray ar-503-ttte (lot 1297366 )((b)(6)), and bearing implant ar-513-be08 (lot 113601337a)((b)(6)).To complete the procedure, the surgeon implanted the following arthrex parts: tibial tray ar-513-t4 (lot 10038080), bearing implant ar-513-be13 (lot 113601414) and stem extension implant ar-513-1450 (lot 10036355).Patient was a female, age (b)(6).During the revision procedure when the ar-613-1 universal handle lot 1391544 ((b)(6)) was being used for the removal of the tibial punch head.The punch head was able to be removed but the handle broke in the process which did not result in patient harm.Handle is being returned for evaluation.Patient medical records of (b)(6) 2016 noted that patient was reporting continued knee pain and swelling.Patient was injected and aspirated at that time.On (b)(6) 2016 records noted that injection/aspiration helped with symptoms for only a few days.Examination of the left knee demonstrated swelling.Palpation of the left knee demonstrated inferior pole patella tenderness, medial joint line and medial tibial plateau tenderness.Mild effusion of the left knee was noted.Records also indicated patient had pain with flexion and no pain with extension.Patient had a positive patellar grind test.Patient was scheduled for the (b)(6) 2016 revision.
Additional Manufacturer Narrative
No further patient information was provided at the time of this report or made available in response to arthrex's follow-up requests.The evaluation revealed that the returned device's critical mating features on surface a (surface that mates with the bearing) are within specification.The damages observed on the surfaces were most likely caused during the extraction of the implant.The contribution of the device to the reported event could not be determined.The catalog number, ar-503-ttte and lot number 1297366, associated with this event has been involved in recall number 1220246-1/29/16-001-r.The information received regarding the event is not sufficient to determine the cause of the event or whether it had any relation to the recall.If additional relevant information is received, a follow-up report will be submitted.
Event or Problem Description
It was reported that on (b)(6) 2015, patient underwent a left tka procedure.On (b)(6) 2016 surgeon performed a revision left tka due to patient pain.During the revision procedure the surgeon explanted the tibial tray ar-503-ttte (lot 1297366 )((b)(4)), and bearing implant ar-513-be08 (lot 113601337a)((b)(4)).To complete the procedure the surgeon implanted the following arthrex parts: tibial tray ar-513-t4 (lot 10038080), bearing implant ar-513-be13 (lot 113601414) and stem extension implant ar-513-1450 (lot 10036355).Patient was a female, (b)(6).During the revision procedure when the ar-613-1 universal handle lot 1391544 ((b)(4)) was being used for the removal of the tibial punch head,.The punch head was able to be removed but the handle broke in the process which did not result in patient harm.Handle is being returned for evaluation.Patient medical records of (b)(6) 2016 noted that patient was reporting continued knee pain and swelling.Patient was injected and aspirated at that time.On (b)(6) 2016 records noted that injection/aspiration helped with symptoms for only a few days.Examination of the left knee demonstrated swelling.Palpation of the left knee demonstrated inferior pole patella tenderness, medial joint line and medial tibial plateau tenderness.Mild effusion of the left knee was noted.Records also indicated patient had pain with flexion and no pain with extension.Patient had a positive patellar grind test.Patient was scheduled for the (b)(6) 2016 revision.

• Brand Name: IBALANCE TKA TIBIAL TRAY SIZE 4
• 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: 5851598
• Report Number: 1220246-2016-00316
• Device Sequence Number: 13759782
• Product Code: JWH
• UDI-Device Identifier: 00888867106727
• UDI-Public: 00888867106727
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: health professional,user faci
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 08/24/2016

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: 06/01/2019
• Device Catalogue Number: AR-503-TTTE
• Device Lot Number: 1297366
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 07/12/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/05/2016
• Supplement Report FDA Received Date: 09/15/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 1220246-1/29/16-001-R.
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 61 YR