MAUDE Adverse Event Report: EXACTECH, INC. LOGIC CC TIB INSERT SIZE 3, 21MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Catalog Number	02-012-65-3021
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	02/11/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitants: 5126729, 02-010-06-0330 - logic cc femoral size 3, right; 5022435, 02-010-06-0531 - logic post.Aug.Block size 3, 5mm; 4862759, 02-010-66-1002 - metaphyseal femoral cone, small, h42mm; 4805607, 02-012-60-1480 - logic stem ext 14mm x 80mm; 4996490, 02-012-60-1612 - logic stem ext 16mm x 120mm; 5091481, 02-012-66-1000 - metaphyseal tibial cone, ml29mm; 5248399, 02-022-45-3020 - truliant tib fit tray cem sz 3f / 2t; 4941793, 200-02-35 - three peg patella 35mm; 5147204, 208-05-03 - cc distal fem augment sz 3, 5mm; 5050368, 208-06-03 - cc distal fem augment sz 3, 10mm; 5050384, 208-06-03 - cc distal fem augment sz 3, 10mm.
Event or Problem Description
It was reported via clinical study, that the 69 yo female patient caught an infection.The date of adverse event onset is unk-unk-unk.The initial surgery date was on 02-20-2018.The patient was revised with exactech components (poly exchange) on 02-11-2020.The patient¿s outcome was last known as resolved.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: b2, d1, h6 - health effect - impact code, medical device problem code, component code, type of investigation, investigation findings, investigation conclusion and h11 the reported event was unable to be confirmed due to limited information received from the customer.No device was returned for evaluation; further, photographs and/or radiograph images were not provided for review.A definitive root cause was unable to be determined; however, may have resulted from an underlying condition associated with the interaction between the implanted device and the patient due to patient illness, unique anatomy, or other condition that impacts the performance of the device.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: LOGIC CC TIB INSERT SIZE 3, 21MM
• 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: ashley harris ; 2320 nw 66th ct; gainesville, FL 32653
• MDR Report Key: 16628493
• Report Number: 1038671-2023-00523
• Device Sequence Number: 14779998
• Product Code: JWH
• UDI-Device Identifier: 10885862266040
• UDI-Public: 10885862266040
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K150890
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2020
• 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): 04/15/2026

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/04/2025
• Device Catalogue Number: 02-012-65-3021
• 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: 02/28/2023
• Supplement Date Received by Manufacturer: 04/08/2026
• Initial Report FDA Received Date: 03/28/2023
• Supplement Report FDA Received Date: 04/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/05/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization; Other
• Patient Age: 69 YR
• Patient Sex: Female
• Patient Weight: 122 KG
• Patient Race: White