MAUDE Adverse Event Report: EXACTECH, INC. LOGIC CR TIB INSERT STD, SZ 2, 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	02-012-47-2009
Medical Device Problem Codes	Fracture (1260); Unstable (1667)
Health Effect - Clinical Codes	Cyst(s) (1800); Failure of Implant (1924); Muscle Weakness/Atrophy (1967); Pain (1994); Discomfort (2330); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581); Joint effusion (4849)
Date of Event	09/07/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported by legal notification, the female patient had an initial right tka on (b)(6) 2016.The patient presented to the clinic with evidence of an effusion.At that time, workup for infection was negative and normal x-ray.Otherwise the knee was stable.The patient returned to the clinic with a letter stating that she was associated with a recall and again continued to have an effusion in her right knee.X-ray did show some slight asymmetry on the standing ap view, and then esr and crp were negative for infection and ct scan showed no significant lytic lesions or loosening of the implants.Therefore, the metal was deemed competent and a polyethylene exchange was discussed.The patient was revised on (b)(6) 2022.There was a large knee effusion with a large associated popliteal cyst.There was no metallosis.There was significant hypertrophy of the synovium and this synovium was excised about the suprapatellar pouch and medial and lateral gutters and intercondylar notch.After this was done, the polyethylene wear was isolated and you could visualize fracturing of the anterior lip of the medial compartment of the polyethylene.There was pitting and delamination, discoloration and fracturing of the polyethylene.The patient was awoken and transferred to recovery in stable condition.No complications occurred throughout the case.
Additional Manufacturer Narrative
Pending investigation.Concomitant medical product(s): serial #: (b)(4), category #: 02-010-03-0320 - logic cr femoral cem, right, sz 2; serial #: b)(4), category #: 200-02-29 - three peg patella 29mm; serial #: b)(4), category #: 02-012-45-2020 - lgc tibial fit tray cem sz 2f / 2t.Recall/correction number: z-0021-2022.
Additional Manufacturer Narrative
The reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear and fracture or due to inclusion of the polyethylene in the packaging recall.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.H6: corrected health effect, medical device, component, and investigation clinical codes.

• Brand Name: LOGIC CR TIB INSERT STD, SZ 2, 9MM
• 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: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 16732014
• Report Number: 1038671-2023-00670
• Device Sequence Number: 20488875
• 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: 2016
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 01/29/2025

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/26/2021
• Device Model Number: 02-012-47-2009
• Device Catalogue Number: 02-012-47-2009
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 03/20/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/20/2023
• Supplement Date Received by Manufacturer: 01/29/2025
• Initial Report FDA Received Date: 04/13/2023
• Supplement Report FDA Received Date: 01/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/07/2013
• 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 Age: 45 YR
• Patient Sex: Female