MAUDE Adverse Event Report: EXACTECH, INC. LOGIC CR TIB INSERT STD, SZ 3, 13MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-012-47-3013
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Unspecified Infection (1930); Pain (1994)
Date of Event	04/14/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: concomitants: 02-012-47-3013 - logic cr tib insert std, sz 3, 13mm, (b)(6); 201-78-82 - collar fixation pin 2pk 40mm, quick release, (b)(6); 02-012-45-3030 - lgc tibial fit tray cem sz 3f / 3t, (b)(6); 02-010-04-0330 - logic cr femoral por, right, sz 3, (b)(6); 201-78-15 - holding pin mini sharp point 4 pk, (b)(6); 200-02-32 - three peg patella 32mm, (b)(6); 203-96-42 - 11-4132 stryker sys 6 90x13/21x1.19, (b)(6).
Event or Problem Description
It was reported via a legal notification that a 66 yo female patient, initial right knee implanted in (b)(6) 2017, underwent a revision procedure in (b)(6) 2017.The party stated that she has suffered pains after her knee surgery.She was revised to a different insert of the same size.No radiographs, or device images were provided.No further information known at this time.
Event or Problem Description
It was reported via a legal notification that a female patient had an initial right knee implanted and then underwent a revision procedure.The party stated that she has suffered pains after her knee surgery.She was revised to a different insert of the same size.No radiographs, or device images were provided.No further information known at this time.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated/corrected: b5, d1, h6.Mdr section codes updated/corrected: a, b, c, d, e.The reason for the reported revision due to infection cannot be conclusively determined; however, it may be related to an underlying patient condition and/or surgical procedure.Additionally, infection is a known surgical risk, as outlined in the ifu.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.

• Brand Name: LOGIC CR TIB INSERT STD, SZ 3, 13MM
• 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 court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66 court; gainesville, FL 32653
• MDR Report Key: 20904021
• Report Number: 1038671-2024-04761
• Device Sequence Number: 4120038
• Product Code: JWH
• UDI-Device Identifier: 10885862174369
• UDI-Public: 10885862174369
• Combination Product (Y/N): N
• Initial Reporter State: NV
• PMA/510(K) Number: K111400
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/02/2025

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/09/2020
• Device Catalogue Number: 02-012-47-3013
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/06/2024
• Supplement Date Received by Manufacturer: 12/01/2025
• Initial Report FDA Received Date: 12/11/2024
• Supplement Report FDA Received Date: 12/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/10/2012
• 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 H11
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR
• Patient Sex: Female