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	08/14/2019
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
On (b)(6) 2018 it was reported by the patient, via the arthrex website, that he underwent a bilateral tka procedure on (b)(6) 2013.Two years after the initial surgery the patient began having instability and pain in both knees (cc138269).On (b)(6) 2018 a revision left tka procedure was performed by the same surgeon due to tibial loosening.((b)(4), which was reported on medwatch 1220246-2018-00556).It has now been reported that the patient had a right tka revision on (b)(6) 2019 by the same surgeon at a different facility using another manufacturer¿s product.The revision was performed due to tibial loosening and pain.The original arthrex right tka devices were explanted and the patient requested they be returned to arthrex for evaluation.Arthrex has not received the implants to date.The following devices were explanted during the (b)(6) 2019 revision: ar-503-ttth, tibial tray (lot 108761238), ar-503-psrj femoral implant (lot 108761219), ar-503-bh10 bearing implant (lot 113601221), ar-504-psd0 patella implant (lot 654468).

• 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: 8970733
• Report Number: 1220246-2019-01302
• Device Sequence Number: 2559439
• 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: 2013
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 09/06/2019

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: 08/31/2015
• Device Model Number: IBAL PATELLA IMPL DOME,37X 10 MM
• Device Catalogue Number: AR-504-PSD0
• Device Lot Number: 654468
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/16/2019
• Initial Report FDA Received Date: 09/06/2019
• 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
• Patient Age: 58 YR