MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIBIA PS MOD INSRT SZ 3.5 13MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	LOGIC TIBIA PS MOD INSRT SZ 3.5 13MM
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Synovitis (2094); Swelling/ Edema (4577); Joint effusion (4849)
Date of Event	05/17/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: logic femoral ps cem right sz 3.5 (cat# 02-010-01-0335 / serial# (b)(4).Lgc tibial fit tray cem sz 3.5f / 3.5t (cat# 02-012-45-3535 / serial# (b)(4).Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported by the exactech knee replacement study, approximately 3.5 years post tka, the (b)(6) y/o male patient experienced severe poly wear.Patent has severe wear creating a concaved surface on the posterior surface of the post.Neither the femoral nor tibial implants were loose.Medial and lateral tibial poly articular surfaces were severely worn particularly posterior lateral and anterior medial.(delamination) also severe wear of the anterior post.Natural patella.No unusual activities.Surgeon explored patient¿s knee because of pain and unexplained effusions.Replaced with a new insert.The event is related to the device and possibly related to the procedure.The device will not return due to study policy.
Additional Manufacturer Narrative
(h3) the evaluation noted that revision reported was likely the result of rotational mismatch between the femoral and tibial components, patient conditions, and third body wear, which resulted in the wear on the polyethylene insert.Additionally, a contributing factor to the severe wear may have been the result of being packaged in a non-conforming vacuum bag for more than five years.However, this cannot be confirmed as the device was not available for evaluation.The most probable root cause associated with the reported event of "prosthesis wear" is associated with material damage to a surface, usually involving progressive loss or displacement of material, due to relative motion between that surface and a contacting substance or substances.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.Additional information: a2, e1, g, g2, g3, h6 component code, h6 investigation codes.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The revision reported was likely the result of rotational mismatch between the femoral and tibial components, patient conditions, and third body wear, which resulted in the wear on the polyethylene insert.Additionally, a contributing factor to the severe wear may have been the result of being packaged in a nonconforming vacuum bag for more than five years.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 PS MOD INSRT SZ 3.5 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 66 court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66 court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 11920996
• Report Number: 1038671-2021-00275
• Device Sequence Number: 3215114
• Product Code: JWH
• UDI-Device Identifier: 10885862001863
• UDI-Public: 10885862001863
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K093360
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Study,Consumer,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/17/2025

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: 01/13/2019
• Device Model Number: LOGIC TIBIA PS MOD INSRT SZ 3.5 13MM
• Device Catalogue Number: 02-012-35-3513
• 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: 05/17/2021
• Supplement Date Received by Manufacturer: 09/28/2021; 01/24/2024; 04/16/2025
• Initial Report FDA Received Date: 06/02/2021
• Supplement Report FDA Received Date: 10/26/2021; 03/13/2025; 04/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/14/2011
• 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
• Outcome Attributed to Adverse Event: Disability; Required Intervention; Hospitalization
• Patient Age: 62 YR
• Patient Sex: Male
• Patient Weight: 119 KG
• Patient Ethnicity: Hispanic