MAUDE Adverse Event Report: EXACTECH, INC. PS CEMENTED FEMORAL SZ 3; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	204-01-03
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Scar Tissue (2060); Osteolysis (2377)
Date of Event	08/28/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that approximately 205 months after a right total knee replacement procedure, the patient underwent a revision procedure to address valgus malalignment, extensor mechanism maltracking (patella maltracking), scar tissue and bone loss.Revision surgery operative notes were provided.Patient left the operating room in stable condition.It was later reported that the patient's femoral component was found to be debonded.No further issues or complications were reported.No additional information is available.
Additional Manufacturer Narrative
D10: 204-04-33 - trapezoid tibial tray sz 3f/3t.208-23-11 cc tibial insert sz 3, 11mm (b)(6).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.

• Brand Name: PS CEMENTED FEMORAL SZ 3
• 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 66 court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653
• MDR Report Key: 23594733
• Report Number: 1038671-2025-03373
• Device Sequence Number: 13156099
• Product Code: JWH
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K933494
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2006
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/15/2026

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: 07/11/2011
• Device Catalogue Number: 204-01-03
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/03/2025
• Supplement Date Received by Manufacturer: 04/21/2026
• Initial Report FDA Received Date: 11/19/2025
• Supplement Report FDA Received Date: 05/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/13/2006
• 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: 76 YR
• Patient Sex: Female