MAUDE Adverse Event Report: EXACTECH, INC. FLUTED STEM EXTENSION 25L X 14 MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	204-34-02
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Date of Event	03/06/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device pending evaluation.Concomitant device(s): serial #: (b)(4), category #: 02-022-35-4010 truliant tib imp ps insert sz 4 10mm, serial #: (b)(4), category #: 02-022-35-4510 truliant tib imp ps insert sz 4.5 10mm, serial #: (b)(4), category #: 201-78-98 2 pk, schanz pin, 4mm x 130mm, serial #: (b)(4), category #: 02-020-11-0240 truliant ps cem fem ps cem left sz 4, serial #: (b)(4), category #: 204-70-00 tibial stem ext.Screw, serial #: (b)(4), category #: 201-78-15 holding pin mini sharp point 4 pk, serial #: (b)(4), category #: 200-07-35 advanced patella 35mm 3 peg implant, serial #: (b)(4), category #: 02-022-45-4040 truliant tib fit tray cem sz 4f / 4t, serial #: (b)(4), category #: 521-78-32 threaded pin size 3.0 collarless 2pk, serial #: (b)(4), category #: 521-78-32 threaded pin size 3.0 collarless 2pk, serial #: (b)(4), category #: 521-78-23 threaded pin size 2.3 collared 2pk, serial #: (b)(4), category #: a10012 gps implant kit v2.
Event or Problem Description
As reported, approximately 3 years post op the initial tka, this male patient was revised due pain at the tip of the tibial stem.Revision occurred with no issues.Poly was in good shape when removed per surgeon.Explants not available.No further information.X-rays attached.
Additional Manufacturer Narrative
Section h10: (h3) based on review of all available information, there is no evidence to suggest that the reported event is related to any design or manufacturing issues; no device information was provided.The cause of the patient¿s pain cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition as associated with the interaction between the implanted device and the patient due to patient illness, unique anatomy, or other condition that impacts the performance of the device.The patient has bilateral knee replacements.These devices are used for treatment not diagnosis.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: b1, b2, h6: clinical code, medical device problem code, investigation findings, investigation conclusions.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: FLUTED STEM EXTENSION 25L X 14 MM
• 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 ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 16649410
• Report Number: 1038671-2023-00552
• Device Sequence Number: 5503822
• Product Code: JWH
• UDI-Device Identifier: 10885862048806
• UDI-Public: 10885862048806
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K933610
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/22/2026

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: 11/05/2024
• Device Catalogue Number: 204-34-02
• 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: 03/07/2023
• Supplement Date Received by Manufacturer: 08/02/2023; 01/16/2026
• Initial Report FDA Received Date: 03/30/2023
• Supplement Report FDA Received Date: 08/24/2023; 01/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/08/2019
• 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: Required Intervention; Hospitalization
• Patient Sex: Male