MAUDE Adverse Event Report: EXACTECH, INC. LOGIC FEMORAL PS CEM RIGHT SZ 4; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-010-01-0340
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Pain (1994); Osteolysis (2377); Ambulation or Postural Difficulties (2544); Inadequate Osseointegration (2646); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581); Joint effusion (4849)
Date of Event	12/18/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: 4312114 02-012-44-4009 - logic tibia implant psc insert, sz 4, 9mm, 5671484 02-012-45-4040 - lgc tibial fit tray cem sz 4f/4t, 4784011 200-02-35 - three peg patella 35mm, 315620 203-96-01 - saw blade new stryk.050 - 11-2222, 264318 203-96-03 - saw blade new stryker.050 - 11-2216.Multiple mdr reports were filed for this event, please see associated reports: 1038671-2021-00741.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.
Event or Problem Description
It was reported that approximately 30 months after a right total knee replacement procedure, the patient underwent a revision procedure to address prosthesis wear, chronic progressive pain, increasing ongoing swelling, frequent clicking and grinding, occasional locking and giving out of the knee, worsening pain with activity, twisting or changing direction, arising from a sitting to standing position, and going up or down the stairs, difficulty walking and bending, and increasing difficulty performing activities of daily living.No additional information is available.
Additional Manufacturer Narrative
Correction: please disregard this report as it was reported in error.Event was previously reported under report #1038671-2021-00741.

• Brand Name: LOGIC FEMORAL PS CEM RIGHT SZ 4
• 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 court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 21104517
• Report Number: 1038671-2025-00153
• Device Sequence Number: 9161636
• Product Code: JWH
• UDI-Device Identifier: 10885862001252
• UDI-Public: 10885862001252
• Combination Product (Y/N): N
• PMA/510(K) Number: K033883
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/05/2025

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: 03/24/2024
• Device Catalogue Number: 02-010-01-0340
• 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: 11/08/2023
• Supplement Date Received by Manufacturer: 03/05/2025
• Initial Report FDA Received Date: 01/08/2025
• Supplement Report FDA Received Date: 03/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/27/2019
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female