MAUDE Adverse Event Report: ARTHREX, INC. IBALANCE PATELLA IMPLANT DOME, 30 X 8 MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	AR-504-PSB8
Health Effect - Clinical Codes	Pain (1994); Ambulation or Postural Difficulties (2544)
Date of Event	07/27/2016
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-504-psb8 and lot number 113601322 combination found no related information.If additional relevant information is received, a follow-up report will be submitted.Device was discarded by the facility.
Event or Problem Description
It was reported that on (b)(6) 2014 a patient underwent a right tka procedure.On (b)(6) 2016 the surgeon performed a revision right tka due to patient pain.During the revision procedure the surgeon explanted the tibial tray ar-503-tttd (lot 108761205)((b)(4)), bearing implant ar-503-bd12 (lot 77941235)((b)(4)) and patella implant ar-504-psb8 (lot 113601322)((b)(4)).To complete the procedure the surgeon implanted the following arthrex products: tibial tray ar-513-t3 (lot 10029431), bearing implant ar-513-bd18 (lot 113601330) and patella implant ar-504-psd0 (lot 113601430).Patient was a female, dob (b)(6) 1963.Explanted parts were discarded by the facility.Patient medical records dated (b)(6) 2016 noted patient had a bone scan which sows uptake consistent with loosening in mtp.Past aspiration and injection provided little relief.Fluid had been sent for cultures and was negative for infection.Patient has pain at night in mtp region and pain with daily activities, walking, stairs.Pain daily.Records noted a jolt was felt in mtp region of knee.Patient has some giving way of knee and instability.Examination with palpation demonstrated medial joint line tenderness and medial tibial plateau tenderness.No lateral tibial plateau tenderness.Trace effusion of the right knee.Some play noted mid flexion.

• Brand Name: IBALANCE PATELLA IMPLANT DOME, 30 X 8 MM
• 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: 5911797
• Report Number: 1220246-2016-00353
• Device Sequence Number: 18856
• Product Code: JWH
• UDI-Device Identifier: 00888867035553
• UDI-Public: 00888867035553
• 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
• Type of Report: Initial
• Report Date (Section B): 08/01/2016

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: 07/01/2018
• Device Catalogue Number: AR-504-PSB8
• Device Lot Number: 113601322
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/01/2016
• Initial Report FDA Received Date: 08/29/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 52 YR