MAUDE Adverse Event Report: EXACTECH, INC. LOGIC CR TIB INSERT STD, SZ 2, 13MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED

Model Number	02-012-47-2013
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Synovitis (2094); Insufficient Information (4580)
Date of Event	07/08/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported via legal documentation, a patient had left knee replacement on (b)(6) 2018.They subsequently underwent left knee revision on (b)(6) 2022, approximately 7 years 2 months after their initial implantation.On (b)(6) 2022 op report noted significant serous fluid identified in the knee and significant synovial hypertrophy and inflammation.The polyethylene had significant erosion and delamination affecting the medial and the posterior quarter of the polyethylene liner.All components were solidly fixed.There was minimal erosion medially on the tibial tray but was extremely stable.The patient tolerated the procedure quite nicely.There is no other patient demographic or medical history available.There is no device return.There are no photos or other images of the device provided.No additional information is available.
Additional Manufacturer Narrative
Pending investigation.D10.Concomitants: 02-010-03-0220 - logic cr femoral cem, left sz 2; 4933710, 02-012-45-2020 - lgc tibial fit tray cem sz 2f / 2t; 5171781, 200-02-29 - three peg patella 29mm; 4048696.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated: g3, h6.The following sections were corrected: h6.Mdr section codes updated/corrected: b, c, d, e, g.The reason for the revision reported in 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.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, 13MM
• 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: kate jacobson ; 3523782617
• MDR Report Key: 17321038
• Report Number: 1038671-2023-01654
• Device Sequence Number: 15083965
• Product Code: JWH
• UDI-Device Identifier: 10885862174260
• UDI-Public: 10885862174260
• Combination Product (Y/N): N
• 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: 2022
• 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
• Report Date (Section B): 01/03/2025

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
• Device Expiration Date: 06/16/2019
• Device Model Number: 02-012-47-2013
• Device Catalogue Number: 02-012-47-2013
• 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: 06/15/2023
• Supplement Date Received by Manufacturer: 01/02/2025
• Initial Report FDA Received Date: 07/13/2023
• Supplement Report FDA Received Date: 01/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/17/2011
• 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 Age: 63 YR
• Patient Sex: Female