MAUDE Adverse Event Report: EXACTECH, INC. LOGIC CR TIB INSERT SLOPE+, SZ 5, 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	02-012-48-5009
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Date of Event	03/03/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D2b: prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer d10.Concomitants: (b)(6) 02-010-03-0350 - logic cr femoral cem, right, sz 5.(b)(6) 02-012-45-5040 - lgc tibial fit tray cem sz 5f / 4t.(b)(6) 200-02-32 - three peg patella 32mm.These devices are used for treatment not diagnosis.Pending investigation.There is no other information available.
Event or Problem Description
It was reported via legal documentation that a patient had an initial right total knee arthroplasty on (b)(6) 2013 and then approximately 9 years, 6 months later experienced a revision surgical procedure on (b)(6) 2023.Patient was revised to competitor¿s devices.Revision operative report of (b)(6) 2023.Preoperative diagnosis: failed right total knee replacement due to poly wear.Indications for procedure: the patient had a previous total knee arthroplasty performed and was diagnosed to have symptomatic poly wear in a recalled implant.The patient has had continued pain and problems.Full infection workup and it was negative.Procedure: they exposed the joint and cleared out the supra-patellar pouch, medial and lateral gutters of the scar tissue and thickened synovium to help with mobilization of the patella.They evaluated the patella to determine what to do with the remaining patella.They cleaned off the membrane around the edges of patellar button.The button was in good shape without any wear, they decided to leave it and remove lateral overhanging osteophytes.They were able to remove the femoral component with minimal bone loss.They had minimal tibial bone loss.After completing the exposure and extensive debridement of the tibial bone to prepare the tibial bone.The new devices were implanted.The patient was placed into a knee immobilizer.The patient tolerated the procedure well.There were no complications.The patient was delivered to the recovery room in good condition.Patient to have follow up appointment in 1 week for wound check.Hospital care: admitted (b)(6) 2023/ discharged (b)(6) 2023.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
The revision reported was likely the result of prosthesis wear.Possible causes for polyethylene wear include malalignment between the implants, high contact stresses during knee flexion, third body wear, patient-related conditions, instability, or any combination of these possibilities.The extent and root cause of the prosthesis wear could not be determined as the devices were not returned for evaluation, and images and radiographs were not provided.There is no other information available.

• Brand Name: LOGIC CR TIB INSERT SLOPE+, SZ 5, 9MM
• 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 66th ct.; gainesville FL 32563
• Manufacturer Contact: michael crader
• MDR Report Key: 17266732
• Report Number: 1038671-2023-01564
• Device Sequence Number: 12740664
• Product Code: JWH
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K111400
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2023
• 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): 09/24/2026

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: 06/20/2019
• Device Model Number: 02-012-48-5009
• Device Catalogue Number: 02-012-48-5009
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/06/2023
• Supplement Date Received by Manufacturer: 02/29/2024; 09/24/2026
• Initial Report FDA Received Date: 07/06/2023
• Supplement Report FDA Received Date: 03/26/2024; 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2011
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 76 YR
• Patient Sex: Male