MAUDE Adverse Event Report: ARTHREX INC. IBALANCE TKA, BEARING IMPLANT, PS, SZ 8, 8MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	AR-513-BJ08
Health Effect - Clinical Codes	Pain (1994); Swelling (2091); Joint Dislocation (2374)
Date of Event	12/08/2015
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 one of two mdr submissions from the same incident.The other is (b)(4).The device was not returned for evaluation and the contribution of the device to the reported event could not be determined.The information received regarding the event is not sufficient to determine the cause of the event.A dhr review for this catalog number, ar-513-bj08 and lot number 113401345 combination found no related information.
Event or Problem Description
It was reported by the patient's attorney that the patient underwent a right total knee arthroplasty on (b)(6) 2015.The following arthrex devices were implanted at the time of procedure: ar-503-tttj tibial tray lot 108761232; ar-513-bj08 tibial bearing lot 113401345; ar-516-8r femoral implant lot 108761339; ar-504-psd0 patella implant lot 113601323.On (b)(6) 2015, the patient had a follow up visit with the original surgeon with complaints of swelling and pain in the right knee.Radiographs were taken they showed the tibial poly insert was dislodged.The surgeon informed the patient it could take up to six months to heal and requested he follow up in three months.The patient returned to the original surgeon on (b)(6) 2015.X-rays were taken and revealed that the poly-insert was 50% subluxed anteriorly and had progressively migrated over the past several months.The surgeon believed that the locking mechanism of the polyethylene was not engaged.The surgeon recommended performing a poly-insert exchange.On (b)(6) 2015, the patient sought a second opinion from a different surgeon.The new surgeon recommended a total revision of the right knee due to the original surgeon's improper sizing and performance of the original knee replacement.A total revision of the right knee replacement was performed on (b)(6) 2015.Additional information obtained 4/27/2018: the revision operative report dated (b)(6) 2015 reported a painful right total knee arthroplasty secondary to mechanical failure with subsidence of tibial component with disassociation and gross wear of polyethylene liner.The operative report further noted the polyethylene component was grossly loose and the femoral component appeared to be well fixed.The surgeon used another manufacturer's product to complete the revision procedure.Patient was a (b)(6) year old male at time of revision.Dob: (b)(6).

• Brand Name: IBALANCE TKA, BEARING IMPLANT, PS, SZ 8, 8MM
• 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: 7506200
• Report Number: 1220246-2018-00178
• Device Sequence Number: 16212136
• Product Code: JWH
• UDI-Device Identifier: 00888867107632
• UDI-Public: 00888867107632
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: 2015
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Attorney
• Type of Report: Initial
• Report Date (Section B): 05/11/2018

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-513-BJ08
• Device Lot Number: 113401345
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/17/2018
• Initial Report FDA Received Date: 05/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AR-503-TTTJ, TIBIAL TRAY, LOT 108761232; AR-504-PSD0, PATELLA IMPLANT, LOT 113601323; AR-516-8R, FEMORAL IMPLANT, LOT 108761339
• Outcome Attributed to Adverse Event: Other
• Patient Age: 63 YR