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

Catalog Number	02-010-01-0220
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Pain (1994); Loss of Range of Motion (2032); Ambulation or Postural Difficulties (2544); Swelling/ Edema (4577)
Date of Event	05/02/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
12-aug-2024 additional information: as reported via email to legal 07-aug -2024 (product identification list, implant op report and revision op report attached).Pre/post diagnosis: failed left total knee arthroplasty secondary to stiffness.Op notes: upon entering the knee there was a large amount of clear looking synovial fluid.Fluid cultures were not sent.Patella was everted and a complete synovectomy of the undersurface of the extensor mechanism and the entire suprapatellar pouch.All scar tissue about the pouch was removed in entirety.Patella found to be well fixed.Patella not revised.Tibia was dislocated forward.The polyethylene was extracted without difficulty.Tibia was noted to be well fixed; carefully removed.There was a large metaphyseal defect after the removal of all cement.For this reason, elected to use a metaphyseal cone.Attention was then directed to the femur.Femoral component found to be well fixed.There was a large amount of hypertrophic bone and retained osteophytes about the distal femur.Femoral component extracted from the cement mantle without any disruption of the cement mantle, no significant bone loss.Revision left tka; replacement of tibial and femoral components.Original summary: it was reported via legal documentation that approximately 109 months after a left total knee replacement procedure, the patient underwent a revision procedure to address prosthesis wear, pain, swelling, stiffness, loss of motion, weakness, difficulty ambulating, surgical revision.No further issues or complications were reported.No additional information is available.
Additional Manufacturer Narrative
D10 concomitant devices (b)(6) 02-010-01-0220 - logic femoral ps cem left sz 2; (b)(6) 02-012-39-2020 - logic tibia fin tray cem sz 2f/2t; (b)(6) 200-03-32 - one peg patella 32mm.
Additional Manufacturer Narrative
1038671-2024-02704.Correction: please disregard this report as it was reported in error.Event was previously reported under report #1038671-2024-02704.

• Brand Name: LOGIC FEMORAL PS CEM LEFT 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 court; gainesville 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th court; gainesville 32653 ; 3523771140
• MDR Report Key: 19964076
• Report Number: 1038671-2024-02787
• Device Sequence Number: 7064307
• Product Code: JWH
• UDI-Device Identifier: 10885862001122
• UDI-Public: 10885862001122
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K033883
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/06/2025

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 Expiration Date: 01/28/2018
• Device Catalogue Number: 02-010-01-0220
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/01/2024
• Supplement Date Received by Manufacturer: 02/06/2025
• Initial Report FDA Received Date: 08/12/2024
• Supplement Report FDA Received Date: 02/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/06/2013
• 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 H11.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 64 YR
• Patient Sex: Female