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

Model Number	LOGIC CC TIB INSERT SIZE 4, 17MM
Medical Device Problem Codes	Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	10/16/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: 7022756, 02-020-11-0240, truliant ps cem fem ps cem left sz 4, 5818048, 02-022-44-4015, truliant tib imp psc insert sz 4, 15mm, 7049316, 02-022-45-4040, truliant tib fit tray cem sz 4f / 4t, 7005224, 200-07-35, advanced patella 35mm 3 peg implant, 7099323, 201-78-15, holding pin mini sharp point 4 pk, s316792, 521-78-23, threaded pin size 2.3 collared 2pk, s279236, 521-78-32, threaded pin size 3.0 collarless 2pk, s317591, 521-78-32, threaded pin size 3.0 collarless 2pk.Based on review of all available information, there is no evidence to suggest that the reported event is related to any design or manufacturing issues.The cause of the infection and subsequent revision cannot be conclusively determined; however, it is most likely related to patient conditions.
Event or Problem Description
It was reported that a 75 yo male, had an initial left knee implanted on (b)(6) 2021, and underwent a revision procedure on (b)(6) 2022, approximately 1 year post the initial procedure due to infection.The joint had to be opened and debridement was necessary.The wound was washed out and the polyethylene was swapped.There were no reported issues with the revision surgical procedure.The patient was last known to be in stable condition following the event.The product not returning; the hospital policy will not allow for the explant to leave the hospital.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: b1, g1, h6 - medical device problem code, component code, type of investigation, investigation findings, investigation conclusions and h11.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.

• Brand Name: LOGIC
• 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: ashley harris ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 15770222
• Report Number: 1038671-2022-01442
• Device Sequence Number: 17797523
• Product Code: JWH
• UDI-Device Identifier: 10885862266149
• UDI-Public: 10885862266149
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K150890
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/27/2026

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 Model Number: LOGIC CC TIB INSERT SIZE 4, 17MM
• Device Catalogue Number: 02-012-65-4017
• 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: 10/16/2022
• Supplement Date Received by Manufacturer: 03/25/2026
• Initial Report FDA Received Date: 11/10/2022
• Supplement Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/15/2019
• 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: Required Intervention
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Weight: 54 KG