MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIBIA PS MOD INSRT SZ 2.5 11MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, CEMENTED, POLYMER/METAL/POLYMER

Model Number	LOGIC TIBIA PS MOD INSRT SZ 2.5 11MM
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Osteolysis (2377); Implant Pain (4561)
Date of Event	12/30/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitants: (b)(6), 02-010-01-0225 - logic femoral ps cem left sz 2.5; (b)(6), 02-012-45-2515 - lgc tibial fit tray cem sz 2.5f / 1.5t; (b)(6), 200-02-32 - three peg patella 32mm; (b)(6), 204-34-02 - fluted stem extension 25l x 14 mm; (b)(6), 204-70-00 - tibial stem ext.Screw.Pending investigation.
Event or Problem Description
As reported via legal department 64 y/o female patient had a left knee replacement on (b)(6) 2013.Approximately 7 years and 4 months after the initial procedure the patient had a left knee revision on (b)(6) 2020.There is no other patient demographic or medical history available.There is no device return.There are no photos or other images of the device provided.No additional information is available.Revision op report on (b)(6) 2020.Post-op diagnosis: failed left total knee arthroplasty secondary to osteolysis.Aseptic loosening femoral component left total knee.Large cortical osteolytic defect non-contained anterior medial tibia.Four large area of osteolysis in the lateral distal femur, contained defect.Findings: loose femoral component with de bonding from the implant between the implant and the cement mantle non-contained anterior medial tibial defect secondary to osteolysis severe polyethylene wear from the medial side of the polyethylene tray, large lytic defect in the anterior distal femur laterally this was a contained defect severe thinning of the lateral femoral condyle.The patient tolerated procedure well and transferred to recovery in stable condition.
Additional Manufacturer Narrative
The reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear and femoral loosening or due to inclusion of the polyethylene in the packaging recall.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, component, and investigation clinical codes.

• Brand Name: LOGIC TIBIA PS MOD INSRT SZ 2.5 11MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, CEMENTED, POLYMER/METAL/POLYMER
• 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 ; 3523771140
• MDR Report Key: 17088767
• Report Number: 1038671-2023-01292
• Device Sequence Number: 6070524
• Product Code: JWH
• UDI-Device Identifier: 10885862001771
• UDI-Public: 10885862001771
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K093360
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2020
• 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): 02/10/2025

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: 01/29/2015
• Device Model Number: LOGIC TIBIA PS MOD INSRT SZ 2.5 11MM
• Device Catalogue Number: 02-012-35-2511
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/11/2023
• Supplement Date Received by Manufacturer: 02/10/2025
• Initial Report FDA Received Date: 06/08/2023
• Supplement Report FDA Received Date: 02/10/2025
• Date Device Manufactured: 02/01/2010
• 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: A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 64 YR
• Patient Sex: Female
• Patient Race: White