MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIBIA IMPLANT PSC INSERT, SZ 4, 11MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	LOGIC TIBIA IMPLANT PSC INSERT, SZ 4, 11MM
Medical Device Problem Codes	Unstable (1667); Naturally Worn (2988)
Health Effect - Clinical Codes	Granuloma (1876); Failure of Implant (1924); Synovitis (2094); Joint Laxity (4526)
Date of Event	10/03/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section d10: concomitant products: rotule 3 plots diam 35 8.5mm optetrak (cat# 200-02-35 / serial# (b)(6)).Composant femoral logic sans ciment t4 gauche (cat# 02-010-02-0240 / serial# (b)(6)).Embase tibiale fit logic cimentee 4f/4t (cat# 02-012-45-4040 / serial# (b)(6)).Tige extension diam 14 lg 40 (cat# 204-34-04 / serial# (b)(6)).Vis pour tige extension tibiale (cat# 204-70-00 / serial# (b)(6)).Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported, approximately three years post initial left tka, the 71 y/o male patient had a full revision surgery.Patient experienced laxity, painful synovitis and extensive granuloma requesting excision.Patient's pe tibial and patella implants presented excessive early wear.Patient was revised to competitor's devices.No further information provided.Images received.Sales rep was unable to obtain x-rays.The devices will be return.
Additional Manufacturer Narrative
H3: the revision reported was likely the result of joint instability, which allowed for extensive wear of the tibial insert.Additionally, a contributing factor to the wear and delamination may have been the result of being packaged in a non-conforming vacuum bag for more than five years.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and corrected information.The revision reported was likely the result of extensive wear of the tibial insert, which may have been the result of joint instability.The noted patella deformation may have been the result of normal contact pressure/articulation with the femur.However, the reported instability cannot be confirmed, and the sequence of events cannot be determined.Additionally, a contributing factor to the insert wear and delamination may have been the result of being packaged in a non-conforming vacuum bad for more than five years.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated/corrected: h6.Mdr section codes updated/corrected: a, e.The revision reported was likely the result of extensive wear of the tibial insert, which may have been the result of joint instability.The noted patella deformation may have been the result of normal contact pressure/articulation with the femur.However, the reported instability cannot be confirmed, and the sequence of events cannot be determined.Additionally, a contributing factor to the insert wear and delamination may have been the result of being packaged in a non-conforming vacuum bad for more than five years.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.

• Brand Name: LOGIC TIBIA IMPLANT PSC INSERT, SZ 4, 11MM
• 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 66 court; gainesville, FL 32653
• Manufacturer Contact: geoff gannon ; 3525541928
• MDR Report Key: 17981107
• Report Number: 1038671-2023-02575
• Device Sequence Number: 14320242
• Product Code: JWH
• UDI-Device Identifier: 10885862173645
• UDI-Public: 10885862173645
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K110547
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 11/20/2025

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: 01/08/2022
• Device Model Number: LOGIC TIBIA IMPLANT PSC INSERT, SZ 4, 11MM
• Device Catalogue Number: 02-012-44-4011
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/05/2023
• Supplement Date Received by Manufacturer: 05/16/2024; 06/21/2024; 09/08/2025; 11/20/2025
• Initial Report FDA Received Date: 10/20/2023
• Supplement Report FDA Received Date: 06/21/2024; 06/24/2024; 10/02/2025; 11/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/14/2014
• 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
• 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
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Weight: 103 KG