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

Model Number	LOGIC TIBIA IMPLANT PSC INSERT, SZ 5, 15MM
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Naturally Worn (2988); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Scar Tissue (2060); Synovitis (2094); Osteolysis (2377); Implant Pain (4561)
Date of Event	01/04/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported via legal documentation, a patient had right knee replacement on (b)(6) 2014.They subsequently underwent right knee revision on (b)(6) 2023, approximately 9 years after their initial procedure.Preoperative x-rays showed increasing lucency along the anterior portion of the right femoral prosthesis, suggesting loosening, as well as severe profound osteolysis and radiolucencies around both components.Intra-operative findings reported include extensive wear posteriorly on the femur and some undersurface wear.It was noted that the tibial polyethylene component was not engaged in the locking mechanism and the metal cap covering the tibial tray holes had become loose.Extensive synovitis and extensive osteolysis were also reported.There is no other patient demographic or medical history available.There is no additional information on the surgical procedure or patient outcome.There is no device return.There are no photos or other images of the device provided.No additional information is available.
Additional Manufacturer Narrative
Pending investigation.
Additional Manufacturer Narrative
The reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear, disassembly, femoral loosening, or due to inclusion of the polyethylene in the packaging recall.Potential contributions of user-related considerations to the event could not be assessed as the devices were not available for evaluation and images and radiographs were not provided.D4: corrected, g4: corrected, h6: corrected health effect, medical device, component, and investigation clinical codes.

• Brand Name: SPECIFIC DEVICE NOT REPORTED
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED
• 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 ; gainesville 32653 ; 3523782617
• MDR Report Key: 17143902
• Report Number: 1038671-2023-01374
• Device Sequence Number: 1931846
• Product Code: JWH
• UDI-Device Identifier: 10885862173744
• UDI-Public: 10885862173744
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K110547
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/21/2025

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: 08/04/2019
• Device Model Number: LOGIC TIBIA IMPLANT PSC INSERT, SZ 5, 15MM
• Device Catalogue Number: 02-012-44-5015
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/19/2023
• Supplement Date Received by Manufacturer: 01/21/2025
• Initial Report FDA Received Date: 06/16/2023
• Supplement Report FDA Received Date: 01/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown