MAUDE Adverse Event Report: EXACTECH, INC. SPECIFIC DEVICE NOT REPORTED; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	ADVANCED PATELLA 32MM 3 PEG IMPLANT
Medical Device Problem Codes	Patient-Device Incompatibility (2682); Naturally Worn (2988)
Health Effect - Clinical Codes	Pain (1994); Joint effusion (4849)
Date of Event	08/16/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reported event was unable to be confirmed due to limited information received from the customer.No device was returned for evaluation; further, photographs and/or radiograph images were not provided for review.Operative notes and/or medical records were not provided for review of usage/ technique.A definitive root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.If any further information is obtained that would change or alter any information provided, a suppl.
Event or Problem Description
It was reported that approximately 5 months after a left total knee replacement procedure, the patient underwent left knee arthroscopy.No additional information was received.No op notes or x-rays.No further issues or complications were reported.No additional information is available.
Additional Manufacturer Narrative
The reason for the reported event cannot be confirmed from the information provided but may be due to patellar tracking and/or inclusion of the polyethylene in the packaging recall.Potential contributions of manufacturing, user, and patient-related considerations to the event could not be assessed as the devices were not available for evaluation and images, radiographs, relevant clinical information, and product information were not provided.D10 concomitant devices: (b)(6), 02-020-11-0240 - truliant ps cem fem ps cem left sz 4; (b)(6), 02-022-45-4040 - truliant tib fit tray cem sz 4f/4t; (b)(6) 02-022-35-4009 - truliant tib imp ps insert sz 4 9 mm.

• Brand Name: SPECIFIC DEVICE NOT REPORTED
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC; 2320 nw 66th ct.; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653
• MDR Report Key: 20835690
• Report Number: 1038671-2024-04598
• Device Sequence Number: 18359151
• Product Code: JWH
• UDI-Device Identifier: 10885862314284
• UDI-Public: 10885862314284
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K160484
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/17/2025

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: 09/14/2025
• Device Model Number: ADVANCED PATELLA 32MM 3 PEG IMPLANT
• Device Catalogue Number: 200-07-32
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/24/2024
• Supplement Date Received by Manufacturer: 01/17/2025
• Initial Report FDA Received Date: 12/03/2024
• Supplement Report FDA Received Date: 01/17/2025
• 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 H11
• Patient Age: 54 YR
• Patient Sex: Male