MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIBIA PS MOD INSRT SZ 4 13MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	LOGIC TIBIA PS MOD INSRT SZ 4 13MM
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/22/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 device was not returned for evaluation and no medical or other records containing treatment information or patient information have been received; therefore, the reported event cannot be confirmed, nor can the circumstances or potential causes or contributors to the alleged event be evaluated.Should additional, material information become available that permits more analysis or conclusions, a supplemental report will be filed accordingly.
Event or Problem Description
Experience report - usa.As reported, approximately 7 years post op initial left tka, this 61 y/o male patient was revised due to loose femur and recall of the tibial insert.Surgeon revised to a constrained size for femur with extension, stem and femoral augments.Also a femoral cone & cc tibial insert.Patient was last known to be in stable condition following the event.X-rays and images attached.No product return; lawyer.(b)(6), 02-010-01-0240 - logic femoral ps cem left sz 4.(b)(6), 02-012-35-4013 - logic tibia ps mod insrt sz 4 13mm.Serial number (b)(6) is confirmed to have been packaged in a vacuum bag that does not contain evoh.Insert and femoral 510k: k033883.Concomitants: (b)(6), 02-012-35-4011 - logic tibia ps mod insrt sz 4 11mm.Serial number (b)(6) is confirmed to have been packaged in a vacuum bag that does not contain evoh.(b)(6), 200-02-38 - three peg patella 38mm.(b)(6), 200-02-38 - three peg patella 38mm.(b)(6), 204-34-02 - fluted stem extension 25l x 14 mm.(b)(6), 204-34-02 - fluted stem extension 25l x 14 mm.(b)(6), 02-012-45-4030 - lgc tibial fit tray cem sz 4f / 3t.(b)(6), 02-012-45-4030 - lgc tibial fit tray cem sz 4f / 3t.(b)(6), 02-010-01-0340 - logic femoral ps cem right sz 4.(b)(6), 204-70-00 - tibial stem ext.Screw.(b)(6), 204-70-00 - tibial stem ext.Screw.
Event or Problem Description
As reported, approximately 7 years post op initial left tka, this 61 y/o male patient was revised due to loose femur and recall of the tibial insert.Surgeon revised to a constrained size for femur with extension, stem and femoral augments.Also a femoral cone & cc tibial insert.Patient was last known to be in stable condition following the event.X-rays and images attached.No product return; lawyer.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: b5.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.
Additional Manufacturer Narrative
D10 concomitants: (b)(6), 02-012-35-4011 - logic tibia ps mod insrt sz 4 11mm.(b)(6), 200-02-38 - three peg patella 38mm.(b)(6), 200-02-38 - three peg patella 38mm.(b)(6), 204-34-02 - fluted stem extension 25l x 14 mm.(b)(6), 204-34-02 - fluted stem extension 25l x 14 mm.(b)(6), 02-012-45-4030 - lgc tibial fit tray cem sz 4f / 3t.(b)(6), 02-012-45-4030 - lgc tibial fit tray cem sz 4f / 3t.(b)(6), 02-010-01-0340 - logic femoral ps cem right sz 4.(b)(6), 204-70-00 - tibial stem ext.Screw.(b)(6), 204-70-00 - tibial stem ext.Screw.

• Brand Name: LOGIC TIBIA PS MOD INSRT SZ 4 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 66th ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653
• MDR Report Key: 21197505
• Report Number: 1038671-2025-00317
• Device Sequence Number: 8325717
• Product Code: JWH
• UDI-Device Identifier: 10885862001900
• UDI-Public: 10885862001900
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K033883
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/12/2025

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: 10/12/2023
• Device Model Number: LOGIC TIBIA PS MOD INSRT SZ 4 13MM
• Device Catalogue Number: 02-012-35-4013
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 06/23/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/23/2023
• Supplement Date Received by Manufacturer: 01/21/2025; 03/12/2025
• Initial Report FDA Received Date: 01/21/2025
• Supplement Report FDA Received Date: 01/21/2025; 03/12/2025
• Date Device Manufactured: 10/13/2015
• Is the Device Labeled for Single Use? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 61 YR
• Patient Sex: Male