MAUDE Adverse Event Report: ARTHREX, INC. IBALANCE TKA TIBIAL TRAY SIZE 8; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	AR-503-TTTJ
Health Effect - Clinical Codes	Pain (1994); Swelling (2091); Palpitations (2467)
Date of Event	06/09/2016
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 information received regarding the event is not sufficient to determine the cause of the event.A dhr review for this catalog number, ar-503-tttj and lot number 108761220 combination found no related information.If additional relevant information is received, a follow-up report will be submitted.Customer will not return the devices.
Event or Problem Description
It was reported that on (b)(6) 2013, patient underwent a left tka procedure.On (b)(6) 2016 surgeon performed a revision left tka due to tibial loosening.During the revision procedure the surgeon explanted the tibial tray ar-503-tttj (lot 108761220), femoral implant ar-503-pslj (lot 108761211), bearing implant ar-503-bj10 (lot 113601230) and patella implant ar-504-psd0 (lot 654468).To complete the procedure the surgeon used another manufacturer's product.Patient, male, (b)(6).Patient medical records of (b)(6) 2016 noted patient was complaining of persistent left knee pain, primarily with walking and descending stairs.Examination of left knee demonstrated warmth and swelling, palpation of the left knee demonstrated medial joint line tenderness and medial tibial plateau tenderness, but no lateral joint line tenderness.Records noted no pain with flexion or extension.Examination tests indicated unstable to varus stress at 30 degrees flexion, but a negative anterior drawer sign, a negative posterior drawer sign and stable to valgus stress at 30 degrees flexion.Prior to examination on (b)(6) 2016 patient had been sent for a ct scan.Records noted x-rays showed periarticular osteophytes and joint space narrowing.Upon examination completion patient was scheduled for a left knee tibial revision/possible full tka revision.
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 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-503-tttj and lot number 108761220 combination found no related information.If additional relevant information is received, a follow-up report will be submitted.
Event or Problem Description
It was reported that on (b)(6) 2013, patient underwent a left tka procedure.On (b)(6) 2016 surgeon performed a revision left tka due to tibial loosening.During the revision procedure the surgeon explanted the tibial tray ar-503-tttj (lot 108761220), femoral implant ar-503-pslj (lot 108761211), bearing implant ar-503-bj10 (lot 113601230) and patella implant ar-504-psd0 (lot 654468).To complete the procedure the surgeon used another manufacturer's product.Patient, male, (b)(6).Patient medical records of (b)(6) 2016 noted patient was complaining of persistent left knee pain, primarily with walking and descending stairs.Examination of left knee demonstrated warmth and swelling, palpation of the left knee demonstrated medial joint line tenderness and medial tibial plateau tenderness, but no lateral joint line tenderness.Records noted no pain with flexion or extension.Examination tests indicated unstable to varus stress at 30 degrees flexion, but a negative anterior drawer sign, a negative posterior drawer sign and stable to valgus stress at 30 degrees flexion.Prior to examination on (b)(6) 2016 patient had been sent for a ct scan.Records noted x-rays showed periarticular osteophytes and joint space narrowing.

• Brand Name: IBALANCE TKA TIBIAL TRAY SIZE 8
• 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: 5778268
• Report Number: 1220246-2016-00281
• Device Sequence Number: 25543
• Product Code: JWH
• UDI-Device Identifier: 00888867106765
• UDI-Public: 00888867106765
• 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: 2013
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/25/2016

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: 09/01/2017
• Device Catalogue Number: AR-503-TTTJ
• Device Lot Number: 108761220
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 06/10/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/08/2016
• Supplement Report FDA Received Date: 09/16/2016
• 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-504-PSDO, IBALANCE PATELLA DOME, LOT 654468
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 68 YR