MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIBIA IMPLANT PSC INSERT, SZ 1.5, 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-012-44-1509
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: (b)(6), 02-010-01-0215 - logic femoral ps cem left sz 1.5, (b)(6), 02-012-45-1515 - lgc tibial fit tray cem sz 1.5f / 1.5t, (b)(6), 200-02-32 - three peg patella 32mm, (b)(6), 201-78-15 - holding pin mini sharp point 4 pk, (b)(6), 201-78-82 - collar fixation pin 2pk 40mm, quick release, (b)(6), 201-78-88 - 4" drill bit, mod.Hex 2-pk, (b)(6), 201-78-89 - 3" drill bit, mod.Hex 2 pack.The product associated with the reported event is within the scope of recall z-0021-2022; however, there is insufficient information to evaluate whether the subject issue of the recall was a cause or contributor to the reported event.The reported event was unable to be confirmed due to limited information received from the customer.No device was returned for evaluation; further, photographs and/or radiograph images were not provided for review.Operative notes and/or medical records were not provided for review of usage/ technique.A definitive root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.
Event or Problem Description
Legal case ¿ usa (master case no.(b)(4), patient id: (b)(6) + left knee, (b)(4) rh is associated with this case.It was reported via legal documentation that approximately 95 months after a left total knee replacement procedure, the patient has experienced prosthesis wear.No medical or surgical interventions were reported.No additional information is available.
Additional Manufacturer Narrative
The prosthesis wear alleged cannot be confirmed as the devices have not been revised.The reason for the legal filing may have been due to the inclusion of the polyethylene in the packaging recall.Potential contributions of user or patient-related considerations could not be assessed as the devices remain implanted and no images, radiographs, or relevant clinical information was provided.B3: corrected.H6: corrected health effect and investigation clinical codes.

• Brand Name: LOGIC TIBIA IMPLANT PSC INSERT, SZ 1.5, 9MM
• 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 66th ct.; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; gainesville, FL 32653
• MDR Report Key: 21394581
• Report Number: 1038671-2025-00936
• Device Sequence Number: 15522201
• Product Code: JWH
• UDI-Device Identifier: 10885862173430
• UDI-Public: 10885862173430
• 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
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/15/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/16/2023
• Device Catalogue Number: 02-012-44-1509
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/24/2024
• Supplement Date Received by Manufacturer: 04/15/2025
• Initial Report FDA Received Date: 02/18/2025
• Supplement Report FDA Received Date: 04/15/2025
• Date Device Manufactured: 03/17/2015
• 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: A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown