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

Catalog Number	02-012-44-2009
Medical Device Problem Codes	Unstable (1667); Naturally Worn (2988)
Health Effect - Clinical Codes	Abdominal Pain (1685); Pain (1994); Synovitis (2094); Joint Laxity (4526); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581); Joint effusion (4849)
Date of Event	08/23/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: n/a 02-010-01-0320 - logic femoral ps cem right sz 2.N/a 02-012-41-2020 - logic tibia traptray cem sz 2f/2t.N/a 200-02-29 - three peg patella 29mm.The product associated with the reported event is within the scope of recall z-0021-2022; however, there is insufficient information to evaluate whether the subject issue of the recall was a cause or contributor to the reported event.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Event or Problem Description
Legal case ¿ usa.Patient id: (b)(6) + right knee.(b)(4) is associated with this case.It was reported that approximately 100 months after a bilateral total knee replacement procedure, the patient underwent a revision procedure to address prosthesis wear, pain, swelling, instability, buckling of right knee, and synovitis.Revision surgery operative notes were provided.Preoperative and postoperative diagnoses noted right knee polyethylene-associated synovitis.The insert showed some evidence of posteromedial wear.The femoral component and tibial component were tested manually for stability and did not demonstrate any instability intra-operatively.It was elected by the surgeon to proceed with a polyethylene insert exchange.No medical or surgical interventions were reported.No additional information is available.

• Brand Name: LOGIC TIBIA IMPLANT PSC INSERT, 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
• MDR Report Key: 21167239
• Report Number: 1038671-2025-00277
• Device Sequence Number: 11831242
• Product Code: JWH
• UDI-Device Identifier: 10885862173478
• UDI-Public: 10885862173478
• 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: 2015
• 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
• Report Date (Section B): 04/15/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/07/2023
• Device Catalogue Number: 02-012-44-2009
• 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: 10/21/2023
• Supplement Date Received by Manufacturer: 04/15/2025
• Initial Report FDA Received Date: 01/16/2025
• Supplement Report FDA Received Date: 04/15/2025
• Date Device Manufactured: 04/08/2015
• 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: Hospitalization; Required Intervention
• Patient Age: 83 YR
• Patient Sex: Female