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

Model Number	02-012-49-2011
Medical Device Problem Codes	Naturally Worn (2988); Insufficient Device Problem Information (3190); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Failure of Implant (1924); Synovitis (2094); Osteolysis (2377); Joint Laxity (4526); Implant Pain (4561); Swelling/ Edema (4577); Insufficient Information (4580)
Date of Event	07/13/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending investigation: d10.Concomitants: (b)(6) , 02-012-45-2030 - lgc tibial fit tray cem sz 2f / 3t.(b)(6), 200-05-26 - inset patella 26mm.(b)(6), 02-010-03-0220 - logic cr femoral cem, left sz 2.
Event or Problem Description
As reported via legal documentation, this patient had bilateral knee replacement with their left knee replaced on (b)(6) 2016.The patient is schedule to have left knee revision on (b)(6) 2023.The reason for revision has not been provided.There is no other patient demographic or medical history available.There is no information on the surgical procedure or patient outcome.There is no device return.There are no photos or other images of the device provided.No additional information is available.
Additional Manufacturer Narrative
H6.Investigation results: the logic device with serial number (b)(6) is confirmed to have been packaged in a vacuum bag that does not contain evoh.The cause of the patient's condition as related to the devices cannot be conclusively determined, insufficient information.The patient has bilateral knee replacements.These devices are used for treatment not diagnosis.There is no other information available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: b3, d6b, h6 (a codes).If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.
Additional Manufacturer Narrative
The revision reported was likely the result of tibial insert prosthesis wear.Additional reasons for the reported revision may be prosthesis wear of the patella, potential femoral loosening and inclusion of the polyethylene in the packaging recall.Additionally, the sequence of events as related to the reported wear and femoral loosening cannot be confirmed and the contributions of each to the reported event cannot be determined.However, the reported tibial insert prosthesis wear is confirmed from the provided information.Potential contributions of user and patient-related considerations to the event could not be assessed as the devices were not available for evaluation and radiographs were not provided.H6: corrected health effect, medical device, component, and investigation clinical codes.

• Brand Name: LOGIC CR TIB INSERT SLOPE++, SZ 2, 11MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED
• 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: geoff gannon ; gainesville 32653 ; 3523782617
• MDR Report Key: 17088999
• Report Number: 1038671-2023-01293
• Device Sequence Number: 6070150
• Product Code: JWH
• UDI-Device Identifier: 10885862174321
• UDI-Public: 10885862174321
• 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: 2016
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/24/2025

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/11/2023
• Supplement Date Received by Manufacturer: 06/13/2023; 02/20/2025; 03/24/2025
• Initial Report FDA Received Date: 06/08/2023
• Supplement Report FDA Received Date: 06/13/2023; 02/20/2025; 03/24/2025
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0021-2022
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown