MAUDE Adverse Event Report: EXACTECH, INC. LOGIC CR TIB INSERT STD, SZ 3, 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	02-012-47-3009
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Insufficient Information (4580)
Date of Event	02/06/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending investigation.Logic cr femoral por, left, sz 3, category #: 02-010-04-0230, serial #: (b)(4), three peg patella, 32mm, category #: 200-02-32, serial #: (b)(4), tibial tray 3f/3t, category #: 02-012-45-3030, serial #: (b)(4), z-0021-2022.
Event or Problem Description
As reported, the patient had an initial left tka on (b)(6) 2021.The patient was revised on (b)(6) 2023 due to poly wear and the insert was replaced.There was no reported breakage of a device or surgical delay/prolongation.The patient was last known to be in stable condition following the event.No other patient information/medical history provided.
Additional Manufacturer Narrative
H3: the reason for the revision cannot be confirmed from the information provided, but may be due to prosthesis wear as reported, patient conditions, or inclusion of the polyethylene in the packaging recall.A contributing factor to the reported wear may have been due to the revised tibial insert having been packaged in a non-conforming bag for five years.However, the reported prosthesis wear could not be confirmed as no images or radiographs were provided and the devices were not available for evaluation.

• Brand Name: LOGIC CR TIB INSERT STD, SZ 3, 9MM
• 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 32653
• Manufacturer Contact: kate jacobson ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 16492654
• Report Number: 1038671-2023-00377
• Device Sequence Number: 17755316
• Product Code: JWH
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K111400
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/14/2026

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 Expiration Date: 03/09/2023
• Device Model Number: 02-012-47-3009
• Device Catalogue Number: 02-012-47-3009
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/21/2023
• Supplement Date Received by Manufacturer: 05/31/2023; 09/14/2026
• Initial Report FDA Received Date: 03/06/2023
• Supplement Report FDA Received Date: 06/06/2023; 09/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/10/2015
• 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: 51 YR
• Patient Sex: Female