MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIBIA IMPLANT PSC INSERT, SZ 3, 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED

Catalog Number	02-012-44-3009
Medical Device Problem Codes	Naturally Worn (2988); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Synovitis (2094); Osteolysis (2377); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	03/01/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending investigation.
Event or Problem Description
As reported via legal documentation, a patient had right knee replacement surgery on (b)(6) 2012.They underwent right knee revision surgery on (b)(6) 2023, approximately 10 years 3 months post primary procedure.(b)(6) 2023 op report postoperative diagnosis: mechanical loosening of internal right knee prosthetic joint.The patient presented with right knee pain and effusion with polyethylene wear and osteolysis on imaging.Upon removal, the surgeon noted the polyethylene insert had significant wear on the medial greater than lateral articular surface.There were some free sheered off pieces of polyethylene within the joint as well.The femoral component was found to be significantly loose and was easily removed.There was no cement that remained on the backside of the implant.Removal of the femoral component revealed aori 2b bone loss from areas of significant osteolysis, most notable at the posterior lateral condyle.The tibial component was found to have significant osteolysis underneath the tray on the medial side.While drilling for the boss of the tibia, there was noted to be a breach of the posterior cortex of the tibia.The patella was also noted to be loose.
Additional Manufacturer Narrative
Report numbers: 1038671-2023-02094 multiple mdr reports were filed for this event, please see associated reports: 1038671-2023-02094 the reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear, femoral loosening, and patellar loosening or due to inclusion of the polyethylene in the packaging recall.Additionally, these devices appear to have been implanted for over ten years prior to the reported event.Potential contributions of user and patient-related considerations to the event could not be assessed as the devices were not available for evaluation and images and radiographs were not provided.H6: corrected health effect, medical device, component, and investigation clinical codes.

• Brand Name: LOGIC TIBIA IMPLANT PSC INSERT, SZ 3, 9MM
• 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, FL 32653 ; 3523782617
• MDR Report Key: 17650228
• Report Number: 1038671-2023-02094
• Device Sequence Number: 7380741
• Product Code: JWH
• UDI-Device Identifier: 10885862173553
• UDI-Public: 10885862173553
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K110547
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 01/07/2025

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
• Device Expiration Date: 03/29/2016
• Device Catalogue Number: 02-012-44-3009
• 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: 07/18/2023
• Supplement Date Received by Manufacturer: 01/07/2025
• Initial Report FDA Received Date: 08/30/2023
• Supplement Report FDA Received Date: 01/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/01/2011
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0021-2022
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR
• Patient Sex: Female