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

Catalog Number	AR-513-BE12
Health Effect - Clinical Codes	Swelling (2091); Fluid Discharge (2686)
Date of Event	02/19/2016
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 contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The cause of the event could not be determined from the information available and without device evaluation.The device history record review revealed nothing relevant to the event.If the device is returned and additional information is obtained, a follow-up report will be submitted.
Event or Problem Description
It was reported by a patient that she had undergone a left tka procedure on (b)(6) 2015.Patient states that almost immediately after the surgery, within weeks, the patient began to have problems with swelling which required draining several times.Patient states therapy was very difficult with her joint continually popping out of place and she was experiencing a popping sound.Patient sought a second opinion and the second surgeon concluded that the joint was loose and would need to be replaced.Surgeon recommended waiting a year from original surgery to allow her body to heal.On (b)(6) 2016 patient underwent a revision left tka procedure at a different facility, performed by the second opinion surgeon.During the revision surgery the new surgeon explanted the following arthrex products: tibial tray, ar-503-ttte, lot 1191338 ((b)(4)), femoral implant, ar-516-4l, lot 108761334 ((b)(4)), bearing implant, ar-513-be12, lot 113601433 ((b)(4)) and patella implant, ar-504-psc9, lot 113601324 ((b)(4)).The new surgeon completed the procedure using another manufacturer's product.Patient had called the fda and was instructed to contact arthrex to report the revision surgery.Medical records dated 9/25/15 (last visit with original surgeon) noted: at time patient was 8 months post op left tkr with patella subluxation that developed 5 months post op.It was noted there was no history of any trauma.Patient had mild effusion of the left knee but no pain with flexion or extension.Also noted was that the patella relocated with active extension from flexion and remains located with motion with lateral patella pressure.Patient was noted to have clinical patella subluxation.Was able to ambulate reasonably well.At time of visit patient was to try a knee sleeve with patella buttress and be re-evaluated in three months.Patient has been asked to provide medical records from second surgeon as well as x-rays from second surgeon and operative reports for both surgeries.

• Brand Name: IBALANCE TKA BEARING IMPLANT 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: 6259670
• Report Number: 1220246-2016-00607
• Device Sequence Number: 955598
• Product Code: JWH
• UDI-Device Identifier: 00888867107274
• UDI-Public: 00888867107274
• 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: consumer
• Initial Reporter Occupation: Patient
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 01/18/2017

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: 09/01/2019
• Device Catalogue Number: AR-513-BE12
• Device Lot Number: 113601433
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/21/2016
• Initial Report FDA Received Date: 01/18/2017
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 66 YR