MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIB INSERT IMPL CRC, SZ 3, 15MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	LOGIC TIB INSERT IMPL CRC, SZ 3, 15MM
Medical Device Problem Codes	Mechanical Problem (1384); Unstable (1667); Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Loss of Range of Motion (2032); Scar Tissue (2060); Osteolysis (2377); Ambulation or Postural Difficulties (2544); Balance Problems (4401); Joint Laxity (4526); Implant Pain (4561); Swelling/ Edema (4577)
Date of Event	05/18/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No device return anticipated due to this being a legal case.Concomitants: 4123716, 200-02-32 - three peg patella 32mm; 4184945, 02-012-45-3030 - lgc tibial fit tray cem sz 3f / 3t; 4186241, 02-010-03-0330 - logic cr femoral cem, right, sz 3.Recall: z-0021-2022.Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
It was reported via a legal notification that a female patient, initial right total knee replacement surgery, (b)(6) 2016, began to suffer from symptoms associated with the defects of exactech knee system as alleged in this complaint, including pain and lack of mobility.As a result of these symptoms, plaintiff underwent revision surgery on (b)(6) 2022 approximately 6 years 4 months post the initial procedure.No further information known.
Additional Manufacturer Narrative
H6: 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 pain and subsequent revision cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition.
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, instability, loss of range of motion, femoral loosening, and tibial loosening or due to inclusion of the polyethylene in the packaging recall.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 and radiographs 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 TIB INSERT IMPL CRC, SZ 3, 15MM
• 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 court; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 15503037
• Report Number: 1038671-2022-01196
• Device Sequence Number: 20772158
• Product Code: JWH
• UDI-Device Identifier: 10885862230430
• UDI-Public: 10885862230430
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K123342
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/11/2025

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: 09/25/2021
• Device Model Number: LOGIC TIB INSERT IMPL CRC, SZ 3, 15MM
• Device Catalogue Number: 02-012-51-3015
• 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: 08/31/2022
• Supplement Date Received by Manufacturer: 10/11/2022; 02/10/2025
• Initial Report FDA Received Date: 09/29/2022
• Supplement Report FDA Received Date: 11/07/2022; 02/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/30/2013
• 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 H10
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female