MAUDE Adverse Event Report: ARTHREX, INC. IBALANCE TKA TIBIAL TRAY SIZE 7; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	AR-503-TTTH
Health Effect - Clinical Codes	Pain (1994); Swelling (2091); No Code Available (3191)
Date of Event	12/26/2016
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-ttth and lot number 1206181, 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 right tka procedure.On (b)(6) 2016 the surgeon performed a revision right tka due to tibial loosening.During the revision procedure the surgeon explanted the tibial tray ar-503-ttth lot 1206181 ((b)(6) (b)(4)), femoral implant ar-516-7r lot 108761338 ((b)(4) (b)(6)) and bearing implant ar-513-bh14 lot 113601336 ((b)(6) (b)(4)).The original patella implant was left in the patient.To complete the procedure the surgeon used another manufacturer's product.Patient was a female, age (b)(6), dob (b)(6) 1970.Patient medical records dated (b)(6) 2016 noted: patient has complained of chronic knee pain ever since the original surgery.Revision tka had been scheduled earlier but was postponed due to personal reasons.Records noted that a previous bone scan demonstrated possible loosening of the tibial component.Examination of the right knee demonstrated warmth and swelling but no erythema.Palpation of the right knee demonstrated inferior patella pole tenderness, medial and lateral joint line tenderness and medial tibial plateau tenderness.Mild effusion of the right knee was noted.Records also noted that the patient has pain through a limited passive range of motion with crepitus and swelling.It was noted that the x-rays showed periarticular osteophytes and joint space narrowing.Results from bone scan performed (b)(6) 2015: reported noted that the blood flow study was normal.The immediate and delayed images demonstrated increased uptake about both the femoral, tibial and patella portion of the prosthesis.Slight separation was noted between the tibial portion of the prosthesis and the adjacent tibial bone proper.Results noted that the findings is suspicious for loosening.

• Brand Name: IBALANCE TKA TIBIAL TRAY SIZE 7
• 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: 6272371
• Report Number: 1220246-2016-00612
• Device Sequence Number: 16165546
• Product Code: JWH
• UDI-Device Identifier: 00888867106710
• UDI-Public: 00888867106710
• 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): 01/24/2017

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-TTTH
• Device Lot Number: 1206181
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/20/2017
• Initial Report FDA Received Date: 01/24/2017
• 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-513-BH14, IBALANCE TKA BEARING, LOT 113601336; AR-516-7R, IBALANCE TKA FEMORAL, LOT 108761338
• Outcome Attributed to Adverse Event: Other
• Patient Age: 46 YR