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

Model Number	LOGIC CR TIB INSERT SLOPE++, SZ 2, 11MM
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	05/01/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, the patient had an initial tka on (b)(6) 2015.The patient was revised on (b)(6) 2022 due to the recall.No other patient information/medical history reported.
Additional Manufacturer Narrative
Pending investigation.Concomitant medical products: 02-010-03-0320 - logic cr femoral cem, right, sz 2 4139525, 02-012-45-2020 - lgc tibial fit tray cem sz 2f / 2t 3718586, 200-02-29 - three peg patella 29mm 4155989, 203-96-42 - 11-4132 stryker sys 6 90x13/21x1.19 43332, h7: z-0021-2022.
Additional Manufacturer Narrative
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 poly swap/revision has been reported to be due to the device recall; no other reason reported.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information: please disregard this report as it was submitted in error.Event was previously reported under report #1038671-2022-00966.

• Brand Name: LOGIC CR TIB INSERT SLOPE++, SZ 2, 11MM
• 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: 15526199
• Report Number: 1038671-2022-01215
• Device Sequence Number: 6079336
• Product Code: JWH
• UDI-Device Identifier: 10885862174321
• UDI-Public: 10885862174321
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K111400
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/14/2025

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: 11/08/2019
• Device Model Number: LOGIC CR TIB INSERT SLOPE++, SZ 2, 11MM
• Device Catalogue Number: 02-012-49-2011
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 09/12/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/12/2022
• Supplement Date Received by Manufacturer: 10/17/2022; 10/14/2025
• Initial Report FDA Received Date: 10/02/2022
• Supplement Report FDA Received Date: 11/04/2022; 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/09/2011
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female