MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIBIA PS MOD INSRT SZ 4 11MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-012-35-4011
Medical Device Problem Codes	Unstable (1667); Naturally Worn (2988)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Failure of Implant (1924); Synovitis (2094); Osteolysis (2377); Joint Laxity (4526); Joint effusion (4849)
Date of Event	09/11/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported via legal documentation that a patient had a left total knee arthroplasty on (b)(6) 2011 and then experienced a revision surgical procedure on (b)(6) 2023 approximately 12 years and 2 months after initial implant.There is no specific device information provided.No images of the devices are provided.The device will not be returned.There is no other information available.
Additional Manufacturer Narrative
H10.Pending investigation.These devices are used for treatments, not diagnosis.There is no other information available.Serial # not confirmed.(b)(6) 02-012-35-4011 - logic tibia ps mod insrt.***serial number (b)(6) is confirmed to have been packaged in a vacuum bag that does not contain evoh.(b)(6) 02-012-35-4011 - logic tibia ps mod insrt ***serial number (b)(6) is confirmed to have been packaged in a vacuum bag that does not contain evoh.
Additional Manufacturer Narrative
The revision reported may have been the result of polyethylene wear, instability, osteolysis, loosening, and bone fracture.Loosening may have been the result of osteolysis, patient-related conditions, and/or insufficient bonds between the implants and the bones, which led to aseptic (non-infected) loosening.Possible causes for polyethylene wear include malalignment between the implants, high contact stresses during knee flexion, third body wear, patient-related conditions, instability, or any combination of these possibilities.The bone fracture may have resulted secondary to the reported osteolysis, but this cannot be confirmed.The extent and root cause of the reported polyethylene wear, osteolysis, loosening, instability, and bone fracture could not be determined as the explanted devices were not returned for evaluation, and radiographs and photographs were not provided.
Additional Manufacturer Narrative
The reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear, instability, patellar loosening, tibial loosening, and femoral 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 PS MOD INSRT SZ 4 11MM
• 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 court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; gainesville 32653
• MDR Report Key: 18985113
• Report Number: 1038671-2024-00675
• Device Sequence Number: 11486597
• Product Code: JWH
• UDI-Device Identifier: 10885862001894
• UDI-Public: 10885862001894
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K033883
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,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 Catalogue Number: 02-012-35-4011
• 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: 09/26/2023
• Supplement Date Received by Manufacturer: 05/22/2024; 01/21/2025
• Initial Report FDA Received Date: 03/27/2024
• Supplement Report FDA Received Date: 06/05/2024; 01/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: UNK.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR
• Patient Sex: Male