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

Catalog Number	02-012-35-4013
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Synovitis (2094); Joint effusion (4849)
Date of Event	06/29/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported via legal documentation the patient had a right knee replacement on (b)(6)2015.Approximately 7 years and 9 months after the initial procedure the patient had a right knee revision on (b)(6) 2023.There is no other patient demographic or medical history available.There is no device return.There are no photos or other images of the device provided.No additional information is available.Revision op report on (b)(6) 2023 diagnosis: aseptic failure status post right knee.A thorough synovectomy was performed."the polyethylene insert which exhibited significant we[ar] around the post medially was removed with an osteotome." a sterile dressing was applied.Patient tolerated the procedure well and there were no known complications.
Additional Manufacturer Narrative
D10: concomitants: (b)(6).02-010-01-0340 - logic femoral ps cem right sz 4.(b)(6).02-012-41-4040 - logic tibia traptray cem sz 4f/4t.(b)(6).200-02-32 - three peg patella 32mm.(b)(6).201-78-81 - 3" trocar, mod.Hex 2pk.(b)(6).201-78-81 - 3" trocar, mod.Hex 2pk.(b)(6).203-90-03 - 11-3978 stablecut gts osc system 6105x19x1.27.(b)(6).203-96-41 - (11-3974) stryker sys 6 90x13x1.27.(b)(6).203-96-42 - 11-4132 stryker sys 6 90x13/21x1.19.(b)(6).204-32-01 - fluted stem extension 11l x 12 mm.(b)(6).204-70-00 - tibial stem ext.Screw.Pending investigation.
Additional Manufacturer Narrative
The reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear and failure of the cement used to secure the femoral component to the femoral bone, which led to loosening at the cement-implant interface, or due to inclusion of the polyethylene in the packaging recall.Potential contributions of user and patient-related considerations to the event could not be assessed as the devices were not available for evaluation and images and radiographs were not provided.H6: corrected health effect, component, and investigation clinical codes.

• Brand Name: LOGIC TIBIA PS MOD INSRT SZ 4 13MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, CEMENTED, POLYMER/METAL/POLYMER
• 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 32653 ; 3523771140
• MDR Report Key: 17651859
• Report Number: 1038671-2023-02100
• Device Sequence Number: 7269243
• Product Code: JWH
• UDI-Device Identifier: 10885862001900
• UDI-Public: 10885862001900
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K033883
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/09/2025

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/17/2019
• Device Catalogue Number: 02-012-35-4013
• 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: 07/18/2023
• Supplement Date Received by Manufacturer: 01/09/2025
• Initial Report FDA Received Date: 08/30/2023
• Supplement Report FDA Received Date: 01/09/2025
• Date Device Manufactured: 03/18/2011
• 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: A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR
• Patient Sex: Male