MAUDE Adverse Event Report: ARTHREX, INC. IBAL PATELLA IMPL DOME,37X 10 MM; PROSTHESIS, KNEE, PATELLO/FEMORAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number	IBAL PATELLA IMPL DOME,37X 10 MM
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Date of Event	10/02/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.
Event or Problem Description
It was reported via the patient's legal representative that the patient had undergone a right total knee arthroplasty on (b)(6) 2014.During the procedure the following arthrex products were implanted: ar-503-tttj, tibial implant, lot 108761234.Ar-503-psrj, femoral implant, lot 108761219.Ar-503-bj12, bearing implant, lot 113601230.Ar-504-psd0, patella implant, lot 113601225.The patient underwent a revision right total knee arthroplasty on (b)(6) 2018 due to painful, loose right total knee arthroplasty.During the procedure the arthrex implants were removed and another manufacturer's products were implanted.The revision operative report findings noted that the tibial and patellar components were grossly loose and the femoral component was poorly fixed.The index and revision surgeries were performed by different surgeons at different locations.The explanted devices were not returned for inspection and the disposition is unknown at this time.

• Brand Name: IBAL PATELLA IMPL DOME,37X 10 MM
• Common Device Name: PROSTHESIS, KNEE, PATELLO/FEMORAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 8748848
• Report Number: 1220246-2019-01191
• Device Sequence Number: 16571013
• Product Code: KRR
• UDI-Device Identifier: 00888867035577
• UDI-Public: 00888867035577
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K160461
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/01/2019

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: 08/31/2017
• Device Model Number: IBAL PATELLA IMPL DOME,37X 10 MM
• Device Catalogue Number: AR-504-PSD0
• Device Lot Number: 113601225
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/06/2019
• Initial Report FDA Received Date: 07/01/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 65 YR