MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIBIA PS MOD INSRT SZ 2.5 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-012-35-2509
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Synovitis (2094); Discomfort (2330); Osteolysis (2377); Aseptic loosening (4883)
Date of Event	09/14/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that approximately 100 months after a left knee replacement procedure, the patient underwent a revision procedure to address prosthesis wear, pain and suffering.No further issues or complications were reported.No additional information is available.
Additional Manufacturer Narrative
D10: concomitants: 3809396 02-010-01-0225 - logic femoral ps cem left sz 2.5 3958140 204-70-00 - tibial stem ext.Screw 3958587 02-012-45-2515 - lgc tibial fit tray cem sz 2.5f / 1.5t 3981224 204-34-02 - fluted stem extension 25l x 14 mm 3944817 200-02-32 - three peg patella 32mm 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 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 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 relevant clinical information was not provided.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.
Event or Problem Description
It was reported via legal documentation approximately 100 months after a left knee replacement procedure, the patient underwent a revision procedure to address prosthesis wear, pain and suffering.A revision op report was provided.Post operative diagnosis noted premature wear of the polyethylene liner and aseptic loosening of left total knee arthroplasty femoral component.Intraoperatively the surgeon observed significant wear to the liner and a loose femoral component.It was noted the patellar and tibial components were well fixed without any signs of significant osteolysis or loosening surrounding the implants.The liner and femoral components were revised.No medical or surgical intervention were reported.No additional information is available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.Additional information: b5, g2, g3, h10 corrected: h6 clinical codes.
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 relevant clinical information was not provided.H6: corrected health effect clinical codes.
Additional Manufacturer Narrative
The reason for the revision reported was most likely due to tibial insert prosthesis wear.The alleged femoral loosening cannot be confirmed from the information provided but may have occurred as a result of prosthesis wear 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.H6: corrected health effect clinical codes.H10: corrected.

• Brand Name: LOGIC TIBIA PS MOD INSRT SZ 2.5 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: 20008433
• Report Number: 1038671-2024-02898
• Device Sequence Number: 12529464
• Product Code: JWH
• UDI-Device Identifier: 10885862001764
• UDI-Public: 10885862001764
• 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: 2015
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 07/22/2025

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: 05/04/2023
• Device Catalogue Number: 02-012-35-2509
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/01/2024
• Supplement Date Received by Manufacturer: 01/04/2025; 04/01/2025; 05/23/2024; 07/22/2025
• Initial Report FDA Received Date: 08/20/2024
• Supplement Report FDA Received Date: 01/06/2025; 04/01/2025; 04/03/2025; 07/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/04/2015
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 64 YR
• Patient Sex: Unknown