MAUDE Adverse Event Report: EXACTECH, INC. LOGIC FEMORAL PS CEM RIGHT SZ 2; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-010-01-0320
Medical Device Problem Codes	Unstable (1667); Naturally Worn (2988)
Health Effect - Clinical Codes	Inflammation (1932); Balance Problems (4401); Joint Laxity (4526); Metal Related Pathology (4530); Implant Pain (4561); Swelling/ Edema (4577)
Date of Event	08/18/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported via legal documentation approximately 29 months after a right total knee replacement procedure, the patient underwent a revision procedure to address prosthesis wear.The patient has experienced, joint pain, instability/balance issues, swelling, right knee pain with subsidence and loosening of tibial component and metallosis.No surgical or medical interventions were reported.No additional information is available.
Additional Manufacturer Narrative
D10: 02-012-42-2008 - sn (b)(6), logic pts, size 2, 8mm; 02-012-45-2020 - sn (b)(6), lgc tibial fit tray cem sz 2f / 2t; 200-02-32 - sn (b)(6), three peg patella 32mm; 02-012-35-2011 - sn (b)(6), logic tibia ps mod insrt sz 2 11mm.Multiple mdr reports were filed for this event, please see associated reports.The reported event was unable to be confirmed due to limited information received from the customer.No device was returned for evaluation; further, photographs and/or radiograph images were not provided for review.Operative notes and/or medical records were not provided for review of usage/ technique.A definitive root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated/corrected: h6.Mdr section codes updated/corrected: b, c, e.The reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear, instability, subsidence and/or tibial loosening.Potential contributions of user and patient-related considerations to the event could not be assessed as the devices were not available for evaluation and images, radiographs, and relevant clinical information were not provided.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: LOGIC FEMORAL PS CEM RIGHT SZ 2
• 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: 21584950
• Report Number: 1038671-2025-01552
• Device Sequence Number: 12951226
• Product Code: JWH
• UDI-Device Identifier: 10885862001214
• UDI-Public: 10885862001214
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K033883
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2016
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/23/2025

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: 11/05/2018
• Device Catalogue Number: 02-010-01-0320
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2024
• Supplement Date Received by Manufacturer: 05/22/2025
• Initial Report FDA Received Date: 03/12/2025
• Supplement Report FDA Received Date: 05/23/2025
• Date Device Manufactured: 11/13/2013
• 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 Sex: Female