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	06/06/2016
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 four submissions for the same patient event.The others are 1220246-2016-00296 ((b)(4)), 1220246-2016-00297 ((b)(4)), 1220246-2016-00298 ((b)(4)).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 1379201 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 that on (b)(6) 2015, a patient underwent a left tka procedure.On (b)(6) 2016 the surgeon performed a revision left tka procedure due to patient pain.During the revision procedure the surgeon explanted the tibial tray ar-503-ttte (lot 1379201), femoral implant ar-516-5l (lot 1373716), bearing implant ar-513-be12 (lot 113601433) and patella implant ar- 504-psb8 (lot 113601439).Patient, female, (b)(6).During the revision procedure the following arthrex products were implanted: tibial tray ar-513-t5 (lot 10034400), femoral implant ar-516-5l (lot 1482387), bearing implant ar-513-bf18 (lot 113601335) and patella implant ar-504-psc9 (lot 113601511).Patient medical records of (b)(6) 2016 noted patient was experiencing recurrent swelling in left knee, any jarring motion of knee recreated pain in knee and patient is able to do stairs one at a time.Examination of the left knee demonstrated swelling and palpation of the left knee demonstrated medial tibial plateau tenderness and lateral tibial plateau tenderness.Mild effusion of the left knee was noted along with pain with flexion.It was noted patient may have micromotion tibial component.Patient medical records of (b)(6) 2016 noted patient continued to have recurrent swelling and pain.It was also noted that patient now has cracking under patella with mild pain.Patient assessment was ankylosis of left knee joint, effusion of left knee and left knee pain.

• 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: 5822739
• Report Number: 1220246-2016-00295
• Device Sequence Number: 774035
• 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
• Report Date (Section B): 07/01/2016

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: 09/01/2019
• Device Catalogue Number: AR-503-TTTE
• Device Lot Number: 137901
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/01/2016
• Initial Report FDA Received Date: 07/26/2016
• 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: 57 YR