MAUDE Adverse Event Report: EXACTECH, INC. ADVANCED PATELLA 32MM 3 PEG IMPLANT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED,

Model Number	ADVANCED PATELLA 32MM 3 PEG IMPLANT
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Scar Tissue (2060)
Date of Event	01/01/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported via clinical studies, exactech truliant knee clinical study, that a 53 yo female patient, height: 68 in, weight: 168 lbs, who had initial implant surgery on her right knee on (b)(6) 2019 for the primary indication of osteoarthritis, was seen approximately 6 months post the initial procedure.Patellar clunk syndrome indicated.Action taken, diagnostic and operative arthroscopy of the right knee with limited synovectomy.Related to device or procedure is unknown.The study indicates outcome resolved on (b)(6) 2020.
Additional Manufacturer Narrative
Concomitants: 02-020-11-0330 - truliant ps cem fem ps cem right sz 3.02-022-45-3020 - truliant tib fit tray cem sz 3f / 2t.02-022-35-3009 - truliant tib imp ps insert sz 3 9mm.Device not returning due to clinical study policies.Additional information, including the product investigation, will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
H2: based on review of all available information, there is no evidence to suggest that the reported event is related to any design or manufacturing issues.The cause of patella clunk and arthroscopy cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition.

• Brand Name: ADVANCED PATELLA 32MM 3 PEG IMPLANT
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED,
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 15259089
• Report Number: 1038671-2022-00946
• Device Sequence Number: 15121401
• Product Code: JWH
• UDI-Device Identifier: 10885862314284
• UDI-Public: 10885862314284
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K160484
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/27/2022

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: 03/03/2024
• Device Model Number: ADVANCED PATELLA 32MM 3 PEG IMPLANT
• Device Catalogue Number: 200-07-32
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/21/2022
• Supplement Date Received by Manufacturer: 08/22/2022; 08/22/2022
• Initial Report FDA Received Date: 08/19/2022
• Supplement Report FDA Received Date: 09/02/2022; 09/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/06/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female
• Patient Weight: 76 KG