MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIB INSERT IMPL CRC, SZ 2.5, 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-012-51-2509
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	08/14/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, approximately 1.5 years post op initial right tka, this 67 y/o female patient was revised.Patient presented with swelling and reduced rom.Dair procedure and lateral facetectomy performed.Liner was exchanged.Patient was last known to be in stable condition following the event.No other patient information/medical history reported.Photos & x-rays attached.Product not returning - sent to rph for analysis.
Additional Manufacturer Narrative
Section h10: (h3) pending evaluation (d10) concomitant device(s): (b)(6): 02-010-04-0325 - logic cr femoral por, right, sz 2.5.(b)(6): 02-012-45-2525 - lgc tibial fit tray cem sz 2.5f / 5t.(b)(6): 200-02-32 - three peg patella 32mm.(b)(6): 201-78-15 - holding pin mini sharp point 4 pk.(b)(6): 201-78-89 - 3 drill bit, mod.Hex 2 pack.(b)(6): 521-78-23 - threaded pin size 2.3 collared.(b)(6): 521-78-23 - threaded pin size 2.3 collared.(b)(6): a10012 - gps implant kit v2.
Additional Manufacturer Narrative
Section h10: h3: the cause of the patient¿s pain and subsequent revision cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition as 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.These devices are used for treatment not diagnosis.
Additional Manufacturer Narrative
Section h10: (g2) report source - company representative should have been checked (g4) date received by manufacturer ¿ date on final submission should have been (b)(6) 2023 (g6) type of report - 30-day should have been checked along with follow-up.

• Brand Name: LOGIC TIB INSERT IMPL CRC, SZ 2.5, 9MM
• 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 ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 17682006
• Report Number: 1038671-2023-02145
• Device Sequence Number: 16796589
• Product Code: JWH
• UDI-Device Identifier: 10885862230362
• UDI-Public: 10885862230362
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K123342
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/12/2024

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 Catalogue Number: 02-012-51-2509
• 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: 08/14/2023
• Supplement Date Received by Manufacturer: 08/14/2023; 01/12/2024
• Initial Report FDA Received Date: 09/05/2023
• Supplement Report FDA Received Date: 01/10/2024; 01/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/27/2021
• 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
• Patient Age: 67 YR
• Patient Sex: Female