MAUDE Adverse Event Report: EXACTECH, INC. LOGIC FEMORAL PS CEM RIGHT SZ 2.5; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-010-01-0325
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Aseptic loosening (4883)
Date of Event	03/08/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, approximately 6 years post op the initial right tka, this 72 y/o female patient was revised due a loose femur and recalled poly.Patient complained of pain.Patient was last known to be in stable condition following the event.Image and xrays attached.Devices are not returning - due to recall hospital will not release implants.
Additional Manufacturer Narrative
Pending evaluation: concomitant device(s): serial #: (b)(4), category #: 02-012-35-2511 - logic tibia ps mod insrt sz 2.5 11mm, serial #: (b)(4), category #: 02-012-45-2525 - lgc tibial fit tray cem sz 2.5f / 2.5t, serial #: (b)(4), category #: 204-70-00 - tibial stem ext.Screw, serial #: (b)(4), category #: 204-34-02 - fluted stem extension 25l x 14 mm, serial #: (b)(4), category #: 200-07-32 - advanced patella 32mm 3 peg implant.
Additional Manufacturer Narrative
Section h10: (h3) the revision reported was likely the result of an insufficient bond between the femoral component and the bone, which led to aseptic (non-infected) femoral loosening and pain.However, this cannot be confirmed as the devices were not available for evaluation.Another contributing factor to the revision may have been inclusion of the implanted polyethylene component in the packaging recall.
Event or Problem Description
Do not process.

• Brand Name: LOGIC FEMORAL PS CEM RIGHT SZ 2.5
• 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: 16655203
• Report Number: 1038671-2023-00556
• Device Sequence Number: 17772491
• Product Code: JWH
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K033883
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 06/02/2026

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: 05/04/2021
• Device Catalogue Number: 02-010-01-0325
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/08/2023
• Supplement Date Received by Manufacturer: 06/12/2023; 05/11/2026; 06/02/2026
• Initial Report FDA Received Date: 03/31/2023
• Supplement Report FDA Received Date: 06/29/2023; 06/01/2026; 06/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/06/2016
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0021-2022
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10; SEE H10.
• Patient Age: 72 YR
• Patient Sex: Female