MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIBIA IMPLANT PSC INSERT, SZ 4, 11MM; SEE H10

Model Number	LOGIC TIBIA IMPLANT PSC INSERT, SZ 4, 11MM
Medical Device Problem Codes	Flaked (1246); Peeled/Delaminated (1454); Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Insufficient Information (4580)
Date of Event	02/07/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a 82 yo male patient, initial right knee implanted on (b)(6) 2015, underwent a revision procedure on (b)(6) 2024, approximately 8 years 10 months post the initial procedure.The patient was revised due to poly wear as well as flaking and delamination.The patient was revised to a 38mm patella, and the tibial insert was revised to a sz 4, 11mm.Fragments of polyethylene were present in the knee joint which the surgeon removed.X-rays were provided.There were no surgical delays during the procedure.The patient was last known to be in stable condition following the event.No explanted devices are available for analysis.The surgeon kept them.Device images were provided.No further information.
Additional Manufacturer Narrative
D2b: prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer.D10: concomitants: 3766400 - 02-010-01-0340 - logic femoral ps cem right sz 4.3795289 - 02-012-45-4040 - lgc tibial fit tray cem sz 4f / 4t.3832369 - 200-02-35 - three peg patella 35mm.Additional information, including the product investigation, will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
H3: the revision reported may have been due to orientation of the femoral and tibial components, third body wear, instability, or any combination of these which led to wear of the tibial insert and patella component.However, this cannot be confirmed because the components were not returned for evaluation.
Additional Manufacturer Narrative
"this follow-up report is being submitted to relay additional and/or corrected information.The following sections were corrected: b1; b2; d1; h6.The revision reported may have been due to orientation of the femoral and tibial components, third body wear, instability, or any combination of these which led to wear of the tibial insert and patella component.However, this cannot be confirmed because the components were not returned for evaluation.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.".

• Brand Name: LOGIC TIBIA IMPLANT PSC INSERT, SZ 4, 11MM
• Common Device Name: SEE H10
• 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: miguel sosa ; 2320 nw 66 court; gainesville, FL 32653 ; 3523782617
• MDR Report Key: 18853045
• Report Number: 1038671-2024-00420
• Device Sequence Number: 7245822
• Product Code: JWH
• UDI-Device Identifier: 10885862173645
• UDI-Public: 10885862173645
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K110547
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/13/2025

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: 05/05/2022
• Device Model Number: LOGIC TIBIA IMPLANT PSC INSERT, SZ 4, 11MM
• Device Catalogue Number: 02-012-44-4011
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/11/2024
• Supplement Date Received by Manufacturer: 05/13/2024; 05/08/2025
• Initial Report FDA Received Date: 03/06/2024
• Supplement Report FDA Received Date: 05/30/2024; 05/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/06/2014
• 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; Hospitalization
• Patient Age: 82 YR
• Patient Sex: Male
• Patient Weight: 90 KG