MAUDE Adverse Event Report: EXACTECH, INC. LOGIC CR TIB INSERT STD, SZ 2, 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, CEMENTED, POLYMER/METAL/POLYMER

Model Number	N/A
Medical Device Problem Codes	Fracture (1260); Naturally Worn (2988); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Failure of Implant (1924); Scar Tissue (2060); Synovitis (2094); Osteolysis (2377); Implant Pain (4561); Insufficient Information (4580)
Date of Event	08/10/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending investigation.
Event or Problem Description
As reported via legal doucmentation the patient had a left knee replacement on 24 apr 2018.Approximately 3 years and 4 months after the initial procedure the patient had a left knee revision on 11 aug 2021.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
This follow-up report is being submitted to relay additional and/or corrected information.The product associated with the reported event is within the scope of recall z-0021-2022; however, there is insufficient information to evaluate whether the subject issue of the recall was a cause or contributor to the reported event.The following sections were updated: a2.A3.D4; expiration date.E1.G1.H4.H6.H8.The following sections were corrected: b1.B2.B3.D1.D4.D7a.D10 concomitants: (b)(6) 02-010-03-0220 - logic cr femoral cem, left sz 2.(b)(6) 02-012-45-2020 - lgc tibial fit tray cem sz 2f / 2t.(b)(6) 200-02-35 - three peg patella 35mm.G4.H6.The reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear, fracture, patellar loosening, and/or due to inclusion of the polyethylene in the packaging recall.Additionally, a contributing factor to the reported wear may have been the result of being packaged in a non-conforming vacuum bag for more than five years.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 STD, SZ 2, 9MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, CEMENTED, POLYMER/METAL/POLYMER
• 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 ; 2320 nw 66th court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 17332158
• Report Number: 1038671-2023-01669
• Device Sequence Number: 6573704
• Product Code: JWH
• UDI-Device Identifier: 10885862174246
• UDI-Public: 10885862174246
• 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: 2018
• Device Explanted Year: 2021
• 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
• Report Date (Section B): 01/06/2025

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: 08/01/2019
• Device Model Number: N/A
• Device Catalogue Number: 02-012-47-2009
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/16/2023
• Supplement Date Received by Manufacturer: 01/04/2025
• Initial Report FDA Received Date: 07/17/2023
• Supplement Report FDA Received Date: 01/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/02/2011
• 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; Hospitalization
• Patient Age: 57 YR
• Patient Sex: Female