MAUDE Adverse Event Report: EXACTECH, INC. LOGIC CR TIB INSERT SLOPE++, SZ 2, 11MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	02-012-49-2011
Medical Device Problem Codes	Naturally Worn (2988); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Osteolysis (2377); Swelling/ Edema (4577)
Date of Event	02/24/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported by legal, this female patient had an initial right tka on (b)(6) 2013.In or around on (b)(6) 2022, the patient was advised that her knee replacement failed for reasons related to the defective device.The patient had a revision on (b)(6) 2022 for issues including, but not limited to, polyethylene wear, bone loss, osteolysis, and/or component loosening.
Additional Manufacturer Narrative
Pending investigation.Concomitant medical products: 2535750 02-012-45-2020 - lgc tibial fit tray cem sz 2f / 2t; 2394098 200-02-35 - three peg patella 35mm; 2424017 201-78-15 - holding pin mini sharp point 4 pk; 2463075 201-78-80 - 3" trocar, hex 2pk; 2535017 201-78-81 - 3" trocar, mod.Hex 2pk; 2042701 201-78-82 - collar fixation pin 2pk 40mm, quick release; 11340 203-96-43 - 11-4137 sryker sys 6 90x13x1.19; 1865739 213-64-41 - axial patella reamer 41mm standard blade.Correction/removal number: z-0021-2022.
Additional Manufacturer Narrative
D10 concomitant addition of femoral component 2250864 02-010-03-0320 - logic cr femoral cem, right, sz 2.Removal of tibial insert as this is the suspect device.H3 based on review of all available information, there is no evidence to suggest that the reported event is related to any design issues.The cause of the subsequent revision cannot be conclusively determined, insufficient information.These devices are used for treatment not diagnosis.D1, d4 catalog #, serial # and expiration date f6, f8 not applicable, this is a manufacturing report h4 manufacture date.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear or due to inclusion of the polyethylene in the packaging recall.Potential contributions of user and patient-related considerations to the event could not be assessed as the devices were not available for evaluation and images and radiographs were not 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 2, 11MM
• 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 ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 15873466
• Report Number: 1038671-2022-01518
• Device Sequence Number: 2505644
• Product Code: JWH
• UDI-Device Identifier: 10885862174321
• UDI-Public: 10885862174321
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K111400
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/18/2025

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: 07/28/2019
• Device Model Number: 02-012-49-2011
• Device Catalogue Number: 02-012-49-2011
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 11/08/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/08/2022
• Supplement Date Received by Manufacturer: 11/08/2022; 04/17/2025
• Initial Report FDA Received Date: 11/28/2022
• Supplement Report FDA Received Date: 03/20/2023; 04/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/29/2011
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female