MAUDE Adverse Event Report: EXACTECH, INC. CEMENTED FINNED TIB. TRA SZ 3F/2T; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	CEMENTED FINNED TIB. TRA SZ 3F/2T
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	02/16/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.D10 concomitants: (b)(6), 204-23-09 - ps tibial inserts sz 3, 9mm.(b)(6), 620-00-02 - platelet rich plasma kit with spray tips.(b)(6), 200-02-29 - three peg patella 29mm.(b)(6), 204-01-03 - ps cemented femoral sz 3.(b)(6), 620-11-02 - accelerate conc.Sys rep by 620-12-02.(b)(6) - sterile disposable containers.(b)(6), 1510-s - cemex system fast 70 gm.
Event or Problem Description
Legal case - (b)(6).As reported via legal documentation, a patient had right knee replacement on (b)(6) 2013.They had right knee revision on (b)(6) 2023, approximately 9 years 6 months after their initial procedure.(b)(6) 2023 v simms, rn/ revision operative report of (b)(6) 2023- failed right knee replacement.The spacer was completely worn out medially and somewhat laterally, posteriorly.After the femur was taken out, the tibia popped out on its own.All debris was removed.The patella was removed, it was completely worn.Hospital care: admitted (b)(6) 2023; discharged (b)(6) 2023.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.Ebi initial surgery attached.Historical record & smartsolve searched for sn/patient name with no results.
Additional Manufacturer Narrative
B4: corrected.
Event or Problem Description
As reported via legal documentation, a patient had right knee replacement on (b)(6) 2013.They had right knee revision on (b)(6) 2023, approximately 9 years 6 months after their initial procedure.The spacer was completely worn out medially and somewhat laterally, posteriorly.After the femur was taken out, the tibia popped out on its own.All debris was removed.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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.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 that approximately 115 months after a right total knee replacement procedure, the patient underwent a revision procedure to address loosening and failure of implant.Revision surgery operative notes were provided.Patient left the operating room in stable condition.No further issues or complications were reported.No additional information is available.

• Brand Name: CEMENTED FINNED TIB. TRA SZ 3F/2T
• 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: 21246279
• Report Number: 1038671-2025-00444
• Device Sequence Number: 17044449
• Product Code: JWH
• UDI-Device Identifier: 10885862039729
• UDI-Public: 10885862039729
• Combination Product (Y/N): N
• PMA/510(K) Number: K932776
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/19/2025

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: 08/27/2017
• Device Model Number: CEMENTED FINNED TIB. TRA SZ 3F/2T
• Device Catalogue Number: 200-04-32
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 05/19/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/19/2023
• Supplement Date Received by Manufacturer: 02/03/2025; 03/19/2025
• Initial Report FDA Received Date: 01/27/2025
• Supplement Report FDA Received Date: 02/03/2025; 03/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/29/2012
• 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: Hospitalization; Required Intervention
• Patient Age: 60 YR
• Patient Sex: Female