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

Catalog Number	AR-503-TTTE
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	12/14/2016
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 device was not returned for evaluation and the contribution of the device to the reported event could not be determined.The catalog number, ar-503-ttte and lot number 913623, 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.Device expected but not yet returned.
Event or Problem Description
It was reported that on (b)(6) 2014 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 913623 ((b)(4)), femoral implant ar-503-psle lot 108761324 ((b)(4)), bearing implant ar-503-be15 lot 654425 ((b)(4)) and patella implant ar-504-psc9 lot 113601237 ((b)(4)).To complete the procedure the surgeon used another manufacturer's product.Patient was a female, (b)(6).Medical records dated (b)(6) 2016 noted: examination of the left knee with palpation demonstrated inferior pole patella and medial tibial plateau tenderness.Mild effusion of the left knee was noted.Range of motion examination of the left knee demonstrated crepitus with motion.Records noted that the x-rays showed periarticular osteophytes and joint space narrowing.Bone scan was performed on both knees on 10/25/16: results stated there was increased uptake involving both knee replacements, the left side more increased than the right.It was also noted that this may suggest loosening which is worse on the left than the right.
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 a follow-up submission for device evaluation.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-ttte and lot number 913623, 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 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 913623 ((b)(4)), femoral implant ar-503-psle lot 108761324 ((b)(4)), bearing implant ar-503-be15 lot 654425 ((b)(4)) and patella implant ar-504-psc9 lot 113601237 ((b)(4)).To complete the procedure the surgeon used another manufacturer's product.Patient was a female, (b)(6).Medical records dated (b)(6) 2016 noted: examination of the left knee with palpation demonstrated inferior pole patella and medial tibial plateau tenderness.Mild effusion of the left knee was noted.Range of motion examination of the left knee demonstrated crepitus with motion.Records noted that the x-rays showed periarticular osteophytes and joint space narrowing.Bone scan was performed on both knees on (b)(6) 2016: results stated there was increased uptake involving both knee replacements, the left side more increased than the right.It was also noted that this may suggest loosening which is worse on the left than the right.

• Brand Name: IBALANCE TKA TIBIAL TRAY 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: 6250940
• Report Number: 1220246-2016-00599
• Device Sequence Number: 865393
• 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: 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,Followup
• Report Date (Section B): 01/25/2017

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: 06/01/2018
• Device Catalogue Number: AR-503-TTTE
• Device Lot Number: 913623
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/19/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/13/2017
• Supplement Report FDA Received Date: 02/10/2017
• 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-503-BE15, IBALANCE TKA BEARING, LOT 654425; AR-503PSLE, IBALANCE TKA FEMORAL, LOT 108761324; AR-504-PSC9, IBALANCE TKA PATELLA LOT 113601237
• Outcome Attributed to Adverse Event: Other
• Patient Age: 55 YR