MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIBIA PS MOD INSRT SZ 5 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-012-35-5009
Medical Device Problem Codes	Unstable (1667); Naturally Worn (2988)
Health Effect - Clinical Codes	Pain (1994); Scar Tissue (2060); Discomfort (2330); Joint Laxity (4526); Swelling/ Edema (4577)
Date of Event	08/31/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: 1310475 200-02-41 three peg patella 41mm.02-012-41-5050 - logic tibia traptray cem sz 5f/5t 1732550, 204-34-02 - fluted stem extension 25l x 14 mm 1894530, 204-70-00 - tibial stem ext.Screw 1919687, 02-010-01-0350; logic femoral ps cem right sz 5, 1847393.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 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.
Event or Problem Description
Legal case ¿ usa (mdl no.3044).Patient id: richard b.Beasley + right knee.(b)(4) is associated with this case.It was reported via legal documentation that approximately 141 months after a right total knee replacement procedure, the patient underwent a revision procedure to address prosthesis wear.Revision surgery operative notes were provided.Patient left the operating room in stable condition.Post operative diagnosis noted wear of the implant.No further issues or complications were reported.No additional information is available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The revision reported was likely the result of the prosthesis wear of the tibial insert and patella over the course of almost 12 years of implantation.High contact pressure during flexion may have additionally caused joint instability, which may have contributed to the prosthesis wear of the tibial insert spine and/or patellar wear and loosening.Potential contributions of user and patient-related considerations to the sequence of events could not be assessed.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: LOGIC TIBIA PS MOD INSRT SZ 5 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: 20625259
• Report Number: 1038671-2024-04277
• Device Sequence Number: 8905843
• Product Code: JWH
• UDI-Device Identifier: 10885862001924
• UDI-Public: 10885862001924
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K033883
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2022
• 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
• Report Date (Section B): 07/28/2025

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: 08/31/2018
• Device Catalogue Number: 02-012-35-5009
• 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: 10/31/2024
• Supplement Date Received by Manufacturer: 07/25/2025
• Initial Report FDA Received Date: 11/06/2024
• Supplement Report FDA Received Date: 07/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2010
• 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: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 66 YR
• Patient Sex: Male