MAUDE Adverse Event Report: EXACTECH, INC. LOGIC FEMORAL PS CEM RIGHT SZ 2; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	LOGIC FEMORAL PS CEM RIGHT SZ 2
Medical Device Problem Codes	Mechanical Problem (1384); Unstable (1667); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Loss of Range of Motion (2032); Discomfort (2330); Arthralgia (2355); Osteolysis (2377); Ambulation or Postural Difficulties (2544); Joint Laxity (4526); Swelling/ Edema (4577)
Date of Event	12/10/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned for evaluation and no medical or other records containing treatment information or patient information have been received; therefore, the reported event cannot be confirmed, nor can the circumstances or potential causes or contributors to the alleged event be evaluated.Should additional, material information become available that permits more analysis or conclusions, a supplemental report will be filed accordingly.
Event or Problem Description
Legal case ¿ mdl no.(b)(6).Rk rev related case (b)(6).**6 dec 2023, (b)(6), rn ¿ ***additional information received from legal on 27-jul-2023/ revision of (b)(6) 2019 revised to zimmer femoral, tibial and patellar components.Revision of all components, right knee.Aseptic failure of right knee; chronic discomfort and restricted motion.Procedure: significant arthrofibrosis was noted and debrided.The femoral implant was noted to be grossly loose and was removed.Significant underlying osteolysis was noted anteriorly and posteriorly as well as in the medial and lateral distal condyles.The patella was noted to be grossly loose and removed.The tibial baseplate was noted to be well fixed and removed.The patient was released from the operating table, transferred to a hospital bed, and taken to the recovery room in stable condition.Optetrak logic psc tibial insert size 2, 9 mm (2106154).Optetrak logic posterior stabilized cemented femoral component size 2.Optetrak logic trapezoid cemented tibial tray size 2f/3t.Optetrak 3-peg patella 35mm.Unable to locate surgeon/patient/serial number in ebi.No serial numbers available.No further information.***original description summary* as reported via legal documentation the patient had a right knee replacement on (b)(6) 2011.Approximately 8 years and 2 months after the initial surgery the patient had a right knee revision on (b)(6) 2019 due to joint pain, joint swelling and stiffness, limited range of motion, loss of mobility, tissue damage, revision surgery, instability, loosening, polyethylene wear, osteolysis.There is no other patient demographic or medical history available.There is no information on the surgical procedure or patient outcome.There is no device return.There are no photos or other images of the device provided.No additional information is available.Ebi initial surgery could not be located.Historical record & smartsolve searched for patient name with no results.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: b5.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.
Event or Problem Description
As reported via legal documentation the patient had a right knee replacement on (b)(6) 2011.Approximately 8 years and 2 months after the initial surgery the patient had a right knee revision on (b)(6) 2019 due to joint pain, joint swelling and stiffness, limited range of motion, loss of mobility, tissue damage, revision surgery, instability, loosening, polyethylene wear, osteolysis.There is no other patient demographic or medical history available.There is no information on the surgical procedure or patient outcome.There is no device return.There are no photos or other images of the device provided.No additional information is available.

• Brand Name: LOGIC FEMORAL PS CEM RIGHT SZ 2
• 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: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653
• MDR Report Key: 20907997
• Report Number: 1038671-2024-04780
• Device Sequence Number: 4008079
• Product Code: JWH
• UDI-Device Identifier: 10885862001214
• UDI-Public: 10885862001214
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K033883
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2019
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: LOGIC FEMORAL PS CEM RIGHT SZ 2
• Device Catalogue Number: 02-010-01-0320
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 04/26/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/26/2023
• Supplement Date Received by Manufacturer: 03/19/2025
• Initial Report FDA Received Date: 12/11/2024
• Supplement Report FDA Received Date: 03/19/2025
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Disability
• Patient Age: 67 YR
• Patient Sex: Male