MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIBIA PS MOD INSRT SZ 2 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-012-35-2009
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Pain (1994); Synovitis (2094); Osteolysis (2377); Fibrosis (3167); Metal Related Pathology (4530); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581); Joint effusion (4849); Aseptic loosening (4883)
Date of Event	01/31/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that approximately 149 months after a right knee replacement procedure, the patient underwent a revision procedure to address prosthesis wear, pain, osteolysis, aseptic loosening, severe reactive synovitis and joint effusion and significant metallosis.No further issues or complications were reported.No additional information is available.
Additional Manufacturer Narrative
D10: concomitant devices unknown the device was not returned for evaluation and no medical or other records containing treatment information or patient information have been received; therefore, the reported event cannot be confirmed, nor can the circumstances or potential causes or contributors to the alleged event be evaluated.Should additional, material information become available that permits more analysis or conclusions, a supplemental report will be filed accordingly.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated: b5 the following sections were corrected: h6.
Event or Problem Description
Additional information received via operative report stated that the patient was evaluated by the surgeon and presented with significant periprosthetic osteolysis and aseptic loosening of their right total knee arthroplasty with associated pain refractory to comprehensive nonoperative management.The operative report further notes that there was severe reactive synovitis and joint effusion consistent with polyethylene wear and component loosening.Additionally, there was significant metalosis.There was no evidence of gross infection.A total synovectomy was performed and fibrotic tissue was removed.On inspection, the femoral component was grossly loose and was easily disimplanted.Notably, there was complete debonding of the femoral component with no evidence of an implant-cement interface.Upon removal of the cement, there were uncontained osteolytic defects involving the medial and lateral femoral condyles which were also thin and unsupportive.The tibial component was found to be loose.The cemented tibial component was explanted without difficulty using instruments to disrupt the implant-cement interface with minimal resultant bone loss.The patellar button was inspected and determined to be loose.As such, the patellar button was removed.The patient emerged from anesthesia and was transferred in stable condition.Additional information received from the facility states the patient was revised due to femoral knee debonding/loosening and polyethylene wear of the left knee joint prosthesis.The insert had no markings but visible fracture damage.

• Brand Name: LOGIC TIBIA PS MOD INSRT SZ 2 9MM
• 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 ; 3523771140
• MDR Report Key: 20086272
• Report Number: 1038671-2024-03135
• Device Sequence Number: 12676323
• Product Code: JWH
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/17/2026

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/06/2019
• Device Catalogue Number: 02-012-35-2009
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/13/2024
• Supplement Date Received by Manufacturer: 11/03/2025; 12/16/2025
• Initial Report FDA Received Date: 08/28/2024
• Supplement Report FDA Received Date: 11/12/2025; 06/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/07/2011
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 70 YR
• Patient Sex: Female