MAUDE Adverse Event Report: EXACTECH, INC. LOGIC FEMORAL PS CEM RIGHT SZ 2.5; Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal

Model Number	LOGIC TIBIA PS MOD INSRT SZ 2.5 11MM
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Erosion (1750); Pain (1994); Implant Pain (4561)
Date of Event	04/14/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Report number 1038671-2023-00405, for left knee revision referenced.Common device name: prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer.Concomitant medical products: 3558013, 02-010-01-0325 - logic femoral ps cem right sz 2.5.2859843, 02-012-45-2515 - lgc tibial fit tray cem sz 2.5f / 1.5t.2896914, 200-02-32 - three peg patella 32mm.3522126, 200-02-32 - three peg patella 32mm.Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
It was reported via legal notification, that patient, had a initial surgical procedure known as bilateral total knee arthroplasty performed on her left knee and right knee on (b)(6) 2014.Upon examination, plaintiffs surgeon determined that plaintiff's optetrak device was failing at a much faster rate than expected making the artificial knee joint more prone to wearing out, loosening, and causing pain, muscle, nerve, and bone damage.This also significantly increases the likelihood that the joint will break.On (b)(6) 2022, approximately 8 years 7 months post initial procedure, plaintiff's surgeon performed revision surgery to remove and replace the exactech devices for both knees.No device return anticipated due to this being a legal case.No device return anticipated due to this being a legal case.
Additional Manufacturer Narrative
G3 h3: based on review of all available information, there is no evidence to suggest that the reported event is related to any design issues.The cause of the subsequent revision cannot be conclusively determined, insufficient information.The patient had bilateral knee replacements.These devices are used for treatment not diagnosis.H6.
Event or Problem Description
Additional information received via experience report- it was reported that a 65 yo female patient, initial right knee implanted on (b)(6) 2014, underwent a revision procedure on (b)(6) 2023.The patient complained of pain.A loose femur was indicated.They were revised to a competitor¿s devices.There was no surgical delays or device breakages.The patient was last known to be in stable condition following the event.No device return anticipated due to the hospital will not release the implants.Photos of the affected product and x-ray images were provided.No further information.
Additional Manufacturer Narrative
Bilateral knee replacements, d1, d4 all, d6b, d10.1638729; 02-012-35-2511 - logic tibia ps mod insrt sz 2.5 11mm, g4 510k, h4, h6 medical device problem code.Initial information provided via legal complaint was incorrect, the device had not been revised on (b)(6) 2022.Pending investigation.There is no other information available.Correction: d1, d4 all femoral device, h7 & h9 femoral device is not under recall.
Additional Manufacturer Narrative
H3: investigation results - the revision reported may have been the result of polyethylene wear and femoral loosening.The prosthesis wear may have been the result of malalignment between the femoral and tibial components, third body wear, instability, patient-related conditions, or any combination of these possibilities.The aseptic (non-infected) femoral loosening may have been the result of both patient-related conditions and an insufficient bond between the femoral component and the bone.However, this cannot be confirmed as the devices were not returned for evaluation.
Event or Problem Description
It was reported that the patient underwent an initial bilateral total knee arthroplasty.Subsequently, it was reported that the patient experienced pain, bone erosion, femoral loosening and prosthesis wear.As a result, the patient underwent a right knee revision approximately 8 years and 11 months after initial implantation.No further patient impact reported.No further information available.

• Brand Name: LOGIC FEMORAL PS CEM RIGHT SZ 2.5
• 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 32653
• Manufacturer Contact: julia goldberg ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 16518677
• Report Number: 1038671-2023-00406
• Device Sequence Number: 3301684
• Product Code: JWH
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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: 2023
• 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,Followup,Followup
• Report Date (Section B): 09/16/2026

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: 04/07/2019
• Device Model Number: LOGIC TIBIA PS MOD INSRT SZ 2.5 11MM
• Device Catalogue Number: 02-010-01-0325
• 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: 02/08/2023
• Supplement Date Received by Manufacturer: 05/15/2023; 06/28/2023; 11/22/2023; 09/15/2026
• Initial Report FDA Received Date: 03/09/2023
• Supplement Report FDA Received Date: 05/17/2023; 06/28/2023; 12/14/2023; 09/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/22/2010
• 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: 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 H11
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR
• Patient Sex: Female