MAUDE Adverse Event Report: EXACTECH, INC. LOGIC CC FEMORAL SIZE 5, RIGHT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-010-06-0350
Medical Device Problem Codes	Unstable (1667); Insufficient Device Problem Information (3190); Loosening of Implant Not Related to Bone-Ingrowth (4002); Lack of Effect (4065)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Discomfort (2330); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	04/07/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this male patient was forced to undergo a painful revision surgery on his right knee because the optetrak knee replacement device that was used in his total knee replacement failed prematurely.
Additional Manufacturer Narrative
Pending evaluation.
Event or Problem Description
It was reported via legal that this male patient underwent a right knee replacement using optetrak knee implant in 2020.The patient experienced pain and discomfort in his right knee, (b)(6) of 2022, patient had a revision.No additional information.
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 issues.The cause of the subsequent revision cannot be conclusively determined, insufficient information.Section h11: the following sections have corrected information: (b5) describe event or problem: it was reported via legal that this male patient underwent a right knee replacement using optetrak knee implant in 2020.The patient experienced pain and discomfort in his right knee, (b)(6) 2022, patient had a revision.No additional information.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear, femoral loosening, loss of range of motion, and tibial loosening.The reported prosthesis wear, femoral loosening, loss of range of motion, and tibial loosening could not be confirmed.Potential contributions of manufacturing, user, and patient-related considerations to the event could not be assessed as the devices were not available for evaluation and images, radiographs, and product 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 CC FEMORAL SIZE 5, RIGHT
• 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: 15372879
• Report Number: 1038671-2022-01048
• Device Sequence Number: 14971907
• Product Code: JWH
• UDI-Device Identifier: 10885862265739
• UDI-Public: 10885862265739
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K150890
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/23/2025

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/21/2020
• Device Catalogue Number: 02-010-06-0350
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/20/2022
• Supplement Date Received by Manufacturer: 09/28/2022; 04/22/2025
• Initial Report FDA Received Date: 09/07/2022
• Supplement Report FDA Received Date: 10/01/2022; 04/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/23/2015
• 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
• Patient Sex: Male