MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIBIA IMPLANT PSC INSERT, SZ 2.5, 13MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	02-012-44-2513
Medical Device Problem Codes	Unstable (1667); Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Discomfort (2330); Ambulation or Postural Difficulties (2544); Joint Laxity (4526); Swelling/ Edema (4577)
Date of Event	03/28/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, the patient had an initial right tka on (b)(6) 2016.The patient experienced progressive pain since fall 2021, intermittent swelling and instability.The patient was revised to a truliant tibial implant psc insert size 2.5, 12mm on (b)(6) 2023.There was no reported breakage of a device or surgical delay/prolongation.The patient was last known to be in stable condition following the event.
Additional Manufacturer Narrative
Pending investigation.Correction removal number: z-0021-2022.
Additional Manufacturer Narrative
The reason for the revision reported cannot be confirmed from the information provided but may be the result of instability or due to inclusion of the polyethylene in the packaging recall.The reason for revision does not appear to be related to prosthesis wear as the images of the explanted device are unremarkable for an implanted device.However, this cannot be confirmed as the devices were not available for evaluation and potential contributions of user and patient-related considerations to the event could not be assessed as radiographs and relevant clinical information were not provided.D10: (b)(6) 02-012-45-2515 - lgc tibial fit tray cem sz 2.5f / 1.5t; (b)(6) 02-010-01-0325 - logic femoral ps cem right sz 2.5; (b)(6) 200-02-32 - three peg patella 32mm; (b)(6) 203-96-21 - (11-2714) stryker 2000 90x13/21x 1.9mm.This follow-up report is being submitted to relay corrected information.The following sections were corrected: h6 clinical code, problem code, component code this follow-up report is being submitted to relay additional information.The following sections were updated: d10.

• Brand Name: LOGIC TIBIA IMPLANT PSC INSERT, SZ 2.5, 13MM
• 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: 16773877
• Report Number: 1038671-2023-00757
• Device Sequence Number: 6849817
• Product Code: JWH
• UDI-Device Identifier: 10885862173539
• UDI-Public: 10885862173539
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: K110547
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 04/28/2025

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: 06/05/2022
• Device Model Number: 02-012-44-2513
• Device Catalogue Number: 02-012-44-2513
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 03/30/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/30/2023
• Supplement Date Received by Manufacturer: 04/14/2025
• Initial Report FDA Received Date: 04/19/2023
• Supplement Report FDA Received Date: 04/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/09/2014
• 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
• Patient Age: 66 YR
• Patient Sex: Female