MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIBIA IMPLANT PSC INSERT, SZ 3, 13MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-012-44-3013
Medical Device Problem Codes	Unstable (1667); Naturally Worn (2988); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Erosion (1750); Failure of Implant (1924); Pain (1994); Discomfort (2330); Ambulation or Postural Difficulties (2544); Joint Laxity (4526); Swelling/ Edema (4577)
Date of Event	02/07/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation.
Event or Problem Description
As reported by legal, approximately 7 years post op the initial tka, this female patient has been advised to undergo and will undergo revision surgery for issues including but not limited to polyethylene wear, bone loss, osteolysis, instability and/or component loosening.
Additional Manufacturer Narrative
Additional information d8 e3 h3: specific device information about the optetrak was not provided.The cause of the patient's condition and planned revision surgery as related to the devices cannot be conclusively determined, insufficient information.These devices are used for treatment not diagnosis.
Additional Manufacturer Narrative
H6.Investigation results -the logic tibia implant psc device with serial number (b)(6) is confirmed to have been packaged in a vacuum bag that does not contain evoh.The cause of the patient¿s pain cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition as associated with the interaction between the implanted device and the patient due to patient illness, unique anatomy, or other condition that impacts the performance of the device.These devices are used for treatment not diagnosis.
Event or Problem Description
The patient experience daily pain and discomfort in her knee which has limited her activities of daily living.There is no other patient demographic or medical history available.There are no radiographic images of the device provided.No additional information is available.

• Brand Name: LOGIC TIBIA IMPLANT PSC INSERT, SZ 3, 13MM
• 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: 16461542
• Report Number: 1038671-2023-00307
• Device Sequence Number: 12390818
• Product Code: JWH
• UDI-Device Identifier: 10885862173577
• UDI-Public: 10885862173577
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K110547
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 07/06/2026

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/08/2023
• Device Catalogue Number: 02-012-44-3013
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/08/2023
• Supplement Date Received by Manufacturer: 02/08/2023; 12/12/2023; 06/15/2026
• Initial Report FDA Received Date: 03/01/2023
• Supplement Report FDA Received Date: 06/19/2023; 12/12/2023; 07/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/08/2015
• 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
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Female