MAUDE Adverse Event Report: ARTHREX, INC. IBALANCE TKA TIBIAL TRAY SIZE 3; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	AR-503-TTTD
Health Effect - Clinical Code	Pain (1994)
Date of Event	09/12/2016
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-tttd and lot number 1336453 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 due to tibial loosening.During the revision procedure, the surgeon explanted the tibial tray ar-503-ttte lot 1336453 ((b)(4)), femoral implant ar-516-4l lot 108761402((b)(4)), bearing implant ar-513-bd13 lot 113601339 ((b)(4)) and patella implant ar-504-psb8 lot 113601236 ((b)(4)).To complete the procedure the surgeon used another manufacturer's product.Patient was a female, (b)(6).Patient medical records dated (b)(6) 2016 noted x-ray findings of left knee as follows: mild tilt of patella, prosthesis in place in proper anatomical alignment without rotation, loosening or stress shielding.Patient medical records dated (b)(6) 2016 noted that a bone scan showed uptake.Report states patient continued to have pain walking, pain is with every step, and also noted patient has sharp pain medial anterior knee with rotation of knee.Patient also reported some instability in knee and difficulty standing up after prolonged sitting.Examination of the left knee demonstrated inferior pole patella tenderness and medial tibial plateau tenderness but no medial joint line tenderness.Mild effusion of the left knee was noted.It was noted in the report summary that x-rays showed periarticular osteophytes and joint space narrowing.

• Brand Name: IBALANCE TKA TIBIAL TRAY SIZE 3
• 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: 6013889
• Report Number: 1220246-2016-00408
• Device Sequence Number: 473651
• 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): 09/13/2016

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: 07/01/2019
• Device Catalogue Number: AR-503-TTTD
• Device Lot Number: 1336453
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/13/2016
• Initial Report FDA Received Date: 10/10/2016
• 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
• Concomitant Medical Products and Therapy/Usage Dates: AR-504-PSB8, IBAL. TKA PATELLA, LOT 113601236; AR-513-BD13, IBALANCE TKA BEARING, LOT 113601339; AR-516-4L, IBALANCE TKA FEMORAL, LOT 108761402
• Outcome Attributed to Adverse Event: Other
• Patient Age: 71 YR