MAUDE Adverse Event Report: EXACTECH, INC. LOGIC KNEE COMPONENTS; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	02-012-47-2509
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Failure of Implant (1924); Insufficient Information (4580)
Date of Event	08/24/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation.Concomitant medical products: 5361391, 02-010-03-0225 - logic cr femoral cem, left sz 2.5; 4888642, 02-012-45-2515 - lgc tibial fit tray cem sz 2.5f / 1.5t; 5170248, 200-02-29 - three peg patella 29mm; 5148047, 201-78-81 - 3" trocar, mod.Hex 2pk; 5427510, 201-78-81 - 3" trocar, mod.Hex 2pk.
Event or Problem Description
As reported, approximately 4 years post op the initial tka, this 69 y/o female patient was revised due is scheduled to under go a revision of a total knee arthroplasty.
Additional Manufacturer Narrative
Section h10: (h3) based on review of all available information, there is no evidence to suggest that the reported event is related to any design issues.The cause of the subsequent planned revision cannot be conclusively determined; insufficient information.Section h11: the following sections have corrected information: (b5) describe event or problem: as reported via legal, approximately 4 years post op the initial tka, this 69 y/o female patient was scheduled to under go a revision of a total knee arthroplasty on (b)(6), 2022.No additional information is available.
Event or Problem Description
As reported via legal, approximately 4 years post op the initial tka, this 69 y/o female patient was scheduled to under go a revision of a total knee arthroplasty on (b)(6), 2022.No additional information is available.
Event or Problem Description
As reported, approximately 4 years post op the initial tka, this female patient was revised.No clinical symptoms reported.No device return.No additional patient information has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: b1, b2, b5, d1, d4 (remove all from initial report-suspect device unknown), d4: remove expiration date., d8, g1, g2, g4, h4: remove manufactured date, h6: clinical code and investigation findings.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: LOGIC KNEE COMPONENTS
• 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 66 ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 3523771140
• MDR Report Key: 15409950
• Report Number: 1038671-2022-01097
• Device Sequence Number: 5640316
• Product Code: JWH
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: UNK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/17/2026

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: 10/24/2019
• Device Model Number: 02-012-47-2509
• 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: 08/24/2022
• Supplement Date Received by Manufacturer: 10/13/2022; 02/04/2026
• Initial Report FDA Received Date: 09/13/2022
• Supplement Report FDA Received Date: 11/08/2022; 02/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/24/2011
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 69 YR
• Patient Sex: Female