MAUDE Adverse Event Report: ARTHREX, INC. IBALANCE TKA TIBIAL TRAY SIZE 2; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	AR-503-TTTC
Health Effect - Clinical Codes	Pain (1994); Joint Swelling (2356)
Date of Event	06/27/2016
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 1220246-2016-00300 ((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-tttc and lot number 982771 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) 2014, patient underwent a right tka procedure during which time the patella was not resurfaced.On (b)(6) 2016, the surgeon performed a revision right tka procedure due to loose tibia and femur.During the revision procedure the surgeon explanted the tibial tray ar-503-tttc (lot 982771), femoral implant ar-503-psrc (lot 108761219) and bearing implant ar-503-bc10 (lot 113601232).Patient, female, (b)(6).The following arthrex products were implanted during the revision: tibial tray ar-513-t1 (lot 10018251), femoral implant ar-516-1r (lot 1355279), bearing implant ar-513-bb16 (lot 113601513), patella implant ar-504-psb8 (lot 113601447) and stem extension implant ar-513-1050 (lot 10018102).Patient medical records of (b)(6) 2016 noted patient reported chronic anterior knee pain, knee swelling with activity, stairs are difficult and episodes of instability of knee.No report at that time of pain in plateau.Examination of right knee demonstrated swelling.Palpation of the right knee demonstrated inferior patellar pole tenderness but no medial tibial plateau or lateral tibial plateau tenderness.Moderate effusion of right knee, moderate crepitus with motion and pain with flexion but not with extension were noted.Records also noted a positive grind test.

• Brand Name: IBALANCE TKA TIBIAL TRAY SIZE 2
• 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: 5822774
• Report Number: 1220246-2016-00299
• Device Sequence Number: 16306525
• 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: 2014
• 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: 12/01/2018
• Device Catalogue Number: AR-503-TTTC
• Device Lot Number: 982771
• 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: 62 YR