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

Model Number	LOGIC TIBIA IMPLANT PSC INSERT, SZ 2, 11MM
Medical Device Problem Codes	Unstable (1667); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Failure of Implant (1924); Joint Laxity (4526)
Date of Event	08/31/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Legal case - (b)(6).Per a report from the legal department, this patient had a rt-knee replacement done on (b)(6) 2016.The patient had the rt-knee revised on (b)(6) 2022 which showed instability of the prosthetic knee joint.Serial #: (b)(4), category #: 02-012-44-2011 - logic tibia implant psc insert, sz 2, 11mm, serial number (b)(4) is confirmed to have been packaged in a vacuum bag that does not contain evoh.Pma-510k: k110547.No ebi results.
Additional Manufacturer Narrative
Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
Additional information- approximately 5 years and 8 months after the initial procedure the patient had the right knee revised on (b)(6) 2022 for instability of prosthetic knee, right revision total knee arthroplasty.There were no complications per the revision operative report and no unusual or notable issues in the report.The patient had a bulky compressive dressing applied and was then transferred to the recovery room in stable condition.The patient was admitted to the hospital on (b)(6) 2022 and then discharged on (b)(6) 2022.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.
Additional Manufacturer Narrative
Additional information- b5, d7a, d8, h2, h7, & h9.H6-investigation -the logic device with serial number (b)(6) is confirmed to have been packaged in a vacuum bag that does not contain evoh.The cause of the patient's condition and revision surgery as related to the devices cannot be conclusively determined, insufficient information.These devices are used for treatment not diagnosis.Correction - f10- should be blank.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: b1, d1, d4 (remove all from initial report-suspect device unknown), g2 (correcting initial report), g3 (remove from initial report-501k unknown) h4 (remove erroneous date from initial report), h6 clinical code, health impact code, device problem code, component code, type of investigation.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.

• Brand Name: LOGIC KNEE COMPONENTS
• 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 66 ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 16714260
• Report Number: 1038671-2023-00641
• Device Sequence Number: 16547891
• Product Code: JWH
• UDI-Device Identifier: 10885862173485
• UDI-Public: 10885862173485
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K110547
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/21/2025

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: 03/20/2022
• Device Model Number: LOGIC TIBIA IMPLANT PSC INSERT, SZ 2, 11MM
• Device Catalogue Number: 02-012-44-2011
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/21/2023
• Supplement Date Received by Manufacturer: 05/22/2023; 10/20/2025
• Initial Report FDA Received Date: 04/11/2023
• Supplement Report FDA Received Date: 05/22/2023; 10/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/24/2014
• 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: A
• 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
• Concomitant Medical Products and Therapy/Usage Dates: UNK.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female