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); Swelling (2091)
Date of Event	10/24/2016
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.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 catalog number, ar-503-ttte and lot number 1336468 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.
Event or Problem Description
It was reported by a patient's wife that her husband, the patient, was scheduled for a tka revision surgery.Original left tka procedure took place on (b)(6) 2015.The following arthrex products were implanted during the (b)(6) 2015 procedure: tibial tray, ar-503-ttte lot 1336468 ((b)(4)), femoral implant, ar-516-5l lot 1373716 ((b)(4)), bearing implant, ar-513-be12 lot 113601403 ((b)(4)) and patella implant ar-504-psb8 lot 113601236 ((b)(4)).Additional information obtained (b)(6) 2016: revision surgery took place (b)(6) 2016.Revision was reported due to loose tibia.During the revision procedure the surgeon explanted the implants listed previously and completed the procedure using another manufacturer's product.Patient was a male, dob (b)(6) 1968, age (b)(6).Patient medical records date 8/16/16 noted: patient is a maintenance worker, heavy labor job, a lot of stairs, kneeling, lifting.He does walk up to 8 miles a day due to job-maintenance.Examination of the left knee demonstrated swelling, but no warmth.Palpation of the left knee demonstrated medial joint line tenderness and medial tibial plateau tenderness, but no lateral joint line tenderness.There was no pain with extension.Mild effusion and mid flexion laxity and pain were noted.Patient had pain through a limited passive range of motion with crepitus and swelling.Records noted the x-rays showed periarticular osteophytes and joint space narrowing.

• 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: 6105966
• Report Number: 1220246-2016-00510
• Device Sequence Number: 13623641
• Product Code: JWH
• UDI-Device Identifier: 00888867106703
• UDI-Public: 00888867106703
• 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
• Report Date (Section B): 10/27/2016

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: 07/01/2019
• Device Catalogue Number: AR-503-TTTE
• Device Lot Number: 1336468
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/27/2016
• Initial Report FDA Received Date: 11/16/2016
• 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
• Concomitant Medical Products and Therapy/Usage Dates: AR-504-PSB8, IBALANCE PATELLA , LOT 1136012; AR-513-BE-12, IBALANCE TKA BEARING, LOT 113601403; AR-516-5L, IBALANCE TKA FEMORAL, LOT 1373716
• Outcome Attributed to Adverse Event: Other
• Patient Age: 48 YR