MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIBIA PS MOD INSRT SZ 4 15MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, CEMENTED, POLYMER/METAL/POLYMER

Model Number	02-012-35-4015
Medical Device Problem Codes	Naturally Worn (2988); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Synovitis (2094); Osteolysis (2377)
Date of Event	10/07/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: serial #: (b)(6), category #: 200-02-35 - three peg patella 35mm.Serial #: (b)(6), category #: 02-010-01-0340 - logic femoral ps cem right sz 4.Serial #: (b)(6), category #: 02-012-45-4040 - lgc tibial fit tray cem sz 4f / 4t.Pending investigation.
Event or Problem Description
Per a report from the legal department a 64 y/o male patient had a right knee replacement on (b)(6) 2014.Approximately 8 years and 6 months after the initial procedure the patient had a right knee revision on (b)(6) 2022.There is no device return.There are no photos or other images of the device provided.No additional information is available.Revision op report - (b)(6) 2022.Postoperative diagnosis: failed right total knee polyethylene due to recall with loose femoral component.There was visible evidence of polyethylene wear and a partially loose tibial component.Severe amount of osteolysis was found around the distal femur and proximal tibia.There was a severe synovial reaction throughout the entire knee and a complete synovectomy was performed.X-rays showed femoral loosening and osteolysis.The patient was awakened and transferred to recovery in stable condition with no complications.
Additional Manufacturer Narrative
H6: investigation result - the revision reported was likely the result of polyethylene wear, loosening and osteolysis as stated in the operative notes.The aseptic (non-infected) loosening may have been the result of an insufficient bond between the implant and the bone and/or patient-related conditions.The prosthesis wear may have been due to malalignment between the implants, high contact stresses during knee flexion, third body wear, patient-related conditions, instability, or any combination of these possibilities.However, the reason for the reported loosening, osteolysis, and prosthesis wear could not be confirmed as the devices were not returned for evaluation, and images/radiographs were unable to be obtained.
Event or Problem Description
It was reported that the patient underwent an initial right total knee arthroplasty.Subsequently, the patient experienced polyethylene wear, femoral loosening, osteolysis and synovitis.As a result, the patient underwent a right knee revision approximately 8 years and 7 months after initial implantation.Patient was transferred to the recovery room in stable condition.No further patient impact reported.No further information available.

• Brand Name: LOGIC TIBIA PS MOD INSRT SZ 4 15MM
• 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 66 court; gainesville FL 32653
• Manufacturer Contact: julia goldberg ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 16808265
• Report Number: 1038671-2023-00823
• Device Sequence Number: 17640269
• Product Code: JWH
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K033883
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/07/2026

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: 07/29/2018
• Device Model Number: 02-012-35-4015
• Device Catalogue Number: 02-012-35-4015
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/05/2023
• Supplement Date Received by Manufacturer: 10/12/2023; 07/07/2026
• Initial Report FDA Received Date: 04/25/2023
• Supplement Report FDA Received Date: 10/19/2023; 07/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/30/2010
• 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: A
• 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; SEE H10.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 64 YR
• Patient Sex: Male