MAUDE Adverse Event Report: EXACTECH, INC. LOGIC CC TIB INSERT SIZE 5, 11MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	02-012-65-5011
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Failure of Implant (1924); Insufficient Information (4580)
Date of Event	09/24/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this patient was revised.Reason was not reported.
Additional Manufacturer Narrative
Pending evaluation.Concomitant medical products: 4145264, 02-010-06-0250 - logic cc femoral size 5, left, 4952893, 02-012-45-5040 - lgc tibial fit tray cem sz 5f / 4t, 4354559, 02-012-60-1425 - logic stem ext 14mm x 25mm and 5027344, 200-02-35 - three peg patella 35mm.
Additional Manufacturer Narrative
Section h10: (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, reason not reported.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following corrections have been made: b1, b2, d8, d2, e2, e3, g3, g6 h6: health effects- clinical codes, component codes, investigation findings.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: LOGIC CC TIB INSERT SIZE 5, 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 66 ct; gainesville FL 32653
• Manufacturer Contact: goeff gannon ; 2320 nw 66th ct; gainesville, FL ; 3523771140
• MDR Report Key: 15885756
• Report Number: 1038671-2022-01535
• Device Sequence Number: 4965469
• Product Code: JWH
• UDI-Device Identifier: 10885862266231
• UDI-Public: 10885862266231
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K150890
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• 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): 10/29/2025

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: 09/24/2023
• Device Model Number: 02-012-65-5011
• Device Catalogue Number: 02-012-65-5011
• 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: 11/10/2022
• Supplement Date Received by Manufacturer: 12/05/2022; 10/14/2025
• Initial Report FDA Received Date: 11/30/2022
• Supplement Report FDA Received Date: 12/22/2022; 10/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/24/2015
• 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: Hospitalization; Required Intervention
• Patient Sex: Unknown