MAUDE Adverse Event Report: EXACTECH, INC. LOGIC CR TIB INSERT SLOPE++, SZ 4, 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-012-49-4009
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Pain (1994); Synovitis (2094); Joint Laxity (4526); Swelling/ Edema (4577)
Date of Event	10/26/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned for evaluation and no medical or other records containing treatment information or patient information have been received; therefore, the reported event cannot be confirmed, nor can the circumstances or potential causes or contributors to the alleged event be evaluated.Should additional, material information become available that permits more analysis or conclusions, a supplemental report will be filed accordingly.
Event or Problem Description
Legal case ¿ usa (master case no.(b)(6)) the patient has filed a short-form complaint in a coordinated action in (b)(6) with master case no.(b)(6).The consolidated long form complaint that applies to cases filed in this coordinated action alleges that patients filing suits in this coordinated action were required ¿to undergo revision surgeries due to severe, pain, swelling, and instability¿ due to ¿wear of the polyethylene components and resulting component loosening and/or other failure failures causing serious complications including tissue damage, osteolysis, permanent bone loss, and other injuries.¿ because the patient has filed a short-form complaint in this coordinated action, the patient appears to allege that the patient was injured as a result of wear of an exactech polyethylene device.
Additional Manufacturer Narrative
D4: added catalog number, expiration date, serial number, and udi d10: 5035887 , 02-010-03-0240 - logic cr femoral cem, left, sz 4.4233734 , 02-012-45-4040 - lgc tibial fit tray cem sz 4f / 4t.5041199 , 200-02-41 - three peg patella 41mm.5073914 , 201-78-81 - 3" trocar, mod.Hex 2pk.G3: added 510k number.H4: added device manufacture date.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The revision reported cannot be confirmed based on the information provided but may be due to the inclusion of the polyethylene in the packaging recall.The tibial insert was packaged in a non-conforming bag for more than 5 years, which may have been a contributing factor in the reported wear and delamination.However, this cannot be confirmed because the component was not returned for evaluation.Potential contributions of user or patient-related considerations could not be assessed and no images, radiographs, or relevant clinical information was provided.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: LOGIC CR TIB INSERT SLOPE++, SZ 4, 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 66th court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th court; gainesville 32653
• MDR Report Key: 19811157
• Report Number: 1038671-2024-02491
• Device Sequence Number: 8380060
• Product Code: JWH
• UDI-Device Identifier: 10885862174512
• UDI-Public: 10885862174512
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K111400
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/15/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/13/2020
• Device Catalogue Number: 02-012-49-4009
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/09/2024
• Supplement Date Received by Manufacturer: 10/17/2024; 04/11/2025
• Initial Report FDA Received Date: 07/23/2024
• Supplement Report FDA Received Date: 11/12/2024; 04/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/14/2012
• 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; Hospitalization
• Patient Sex: Unknown