MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIBIA IMPLANT PSC INSERT, SZ 3, 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	02-012-44-3009
Medical Device Problem Code	Naturally Worn (2988)
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	01/04/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending investigation.Correction removal number:z-0021-2022.
Event or Problem Description
As reported, the male patient had an initial tka on (b)(6) 2017.The patient was revised on (b)(6) 2023 due to accelerated and preventable wear of the optetrak logic ps polyethylene tibial insert.The patient has suffered and continues to suffer permanent and debilitating injures and damages, including but not limited to, significant pain and discomfort; gait impairment; poor balance; difficulty walking; component part loosening; soft tissue damage; bone loss; and other injuries presently undiagnosed, which all require ongoing medical care.No other patient information/medical history reported.
Additional Manufacturer Narrative
There is no other patient demographic or medical history available.There is no information on the surgical procedure or patient outcome.There is no device return.There are no photos or other images of the device provided.No additional information is available.H6.Investigation - the revision reported may have been the result of prosthesis wear.However, the reported prosthesis wear and contributions of implant positioning and/or patient-related conditions to the sequence of events cannot be confirmed as the devices were not available for evaluation and limited information was provided at the time of evaluation.

• Brand Name: LOGIC TIBIA IMPLANT PSC INSERT, SZ 3, 9MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED
• 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: kate jacobson ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 16595625
• Report Number: 1038671-2023-00491
• Device Sequence Number: 5576879
• Product Code: JWH
• UDI-Device Identifier: 10885862173553
• UDI-Public: 10885862173553
• 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: 2017
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/13/2026

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/22/2025
• Device Model Number: 02-012-44-3009
• Device Catalogue Number: 02-012-44-3009
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 02/27/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/27/2023
• Supplement Date Received by Manufacturer: 04/05/2023; 06/23/2026
• Initial Report FDA Received Date: 03/22/2023
• Supplement Report FDA Received Date: 04/14/2023; 07/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/22/2017
• 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: Female