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

Catalog Number	9999
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Pain (1994); Synovitis (2094); Unspecified Musculoskeletal problem (4535); Swelling/ Edema (4577)
Date of Event	01/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: 6061609 02-010-06-0220 - logic cc femoral size 2, left, 6366036 02-012-61-4000 - logic offset stem ext coupler 4mm, 6366053 02-012-61-4000 - logic offset stem ext coupler 4mm, 6135451 02-012-64-1280 - tru fluted stm ext 12mm x 80mm blast, 6326926 02-012-64-1280 - tru fluted stm ext 12mm x 80mm blast, 6275482 02-022-45-2020 - truliant tib fit tray cem sz 2f / 2t, 6580336 201-78-15 - holding pin mini sharp point 4 pk, 6580449 204-70-00 - tibial stem ext.Screw, 6174947 208-05-02 - cc distal fem augment sz 2, 5mm, 6536532 208-05-02 - cc distal fem augment sz 2, 5mm.
Event or Problem Description
It was reported via clinical study, that the 54 yo female patient was experiencing synovitis and fixed flexion deformity causing constant pain and swelling.Bone scan shows increased uptake around tibiofemoral and patellar components on the left.The date of adverse event onset is unk-unk-2021.Revision was recommended and scheduled for (b)(6) 2021 but was deferred because hemoglobin a1c was >11 which is now better controlled.Therefore, the patient was rescheduled and revised on (b)(6) 2023.The patient¿s outcome was last known as continuing.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: b3(remove date of event from initial report was unk), b5, d1, d6b(remove explanted date from initial report was unk), d4 (remove all from initial report-suspect device unknown), g4 (remove 501k from initial report-unknown), h4 (remove manufacture date from initial report-unknown), h6 clinical code, health impact code, device problem code, component code, investigation findings, type of investigation, investigation conclusion codes.(b5): it was reported that the patient required a revision procedure which was rescheduled for a future date.There is no additional information that confirms a revision procedure took place at this time.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 revision cannot be conclusively determined, insufficient information.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, SEMI-CONSTRAINED, CEMENTED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66th ct.; gainesville FL 32563
• Manufacturer Contact: kate jacobson
• MDR Report Key: 16631585
• Report Number: 1038671-2023-00527
• Device Sequence Number: 5311129
• Product Code: JWH
• UDI-Device Identifier: 10885862304100
• UDI-Public: 10885862304100
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K152170
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/03/2026

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?: No
• Device Expiration Date: 04/24/2025
• Device Catalogue Number: 9999
• 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: 03/01/2023
• Supplement Date Received by Manufacturer: 02/02/2026
• Initial Report FDA Received Date: 03/28/2023
• Supplement Report FDA Received Date: 02/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/25/2017
• 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: Other; Required Intervention
• Patient Age: 54 YR
• Patient Sex: Female
• Patient Weight: 87 KG