MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIBIA PS MOD INSRT SZ 4 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-012-35-4009
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Naturally Worn (2988)
Health Effect - Clinical Codes	Synovitis (2094); Insufficient Information (4580)
Date of Event	03/15/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Legal case ¿ usa patient id: (b)(6) + left knee.It was reported that approximately 119 months after a left total knee replacement procedure, the patient underwent a revision procedure with dr.(b)(6) md, at (b)(6) in (b)(6), to address clinical and radiographic signs of premature polyethylene wear.Revision surgery operative notes were provided.Preoperative and postoperative diagnoses indicated failed left total knee tibial polyethylene due to premature poly wear and poly recall.Operative findings indicated there was found to be a clean wound with clear synovial joint fluid.There were well-fixed femoral, tibial, and patellar components with no osteolysis.There was a visible amount and palpable amount of polyethylene wear within the weightbearing portions of the tibial polyethylene.There was encapsulated polyethylene debris within the synovium with a secondary thickened synovium and a complete synovectomy was performed.Attention was then turned to the tibial polyethylene insert, which was dislodged from the tibial component.A trial reduction with a 10mm insert was trialed.The knee was taken into full extension with excellent range of motion to 130 degrees with good patellar tracking.The trial component was then removed.The final tibial polyethylene insert was locked in the tibial tray.The knee was once again taken through a final range of motion.The patient was awakened and transferred to recovery in stable condition.There were no complications.No additional information is available.The serial number (b)(6) is confirmed to be a part of recall number: z-0021-2022 02-012-35-4009 - logic tibia ps mod insrt sz 4 9mm serial: (b)(6) 510k: k033883 udi: (b)(4) product code: jwh x-ray: no operative notes: yes concomitant devices: (b)(6) 02-010-01-0240 - logic femoral ps cem left sz 4; (b)(6) 02-012-45-4040 - lgc tibial fit tray cem sz 4f / 4t; (b)(6) 200-02-35 - three peg patella 35mm; (b)(6) 204-34-02 - fluted stem extension 25l x 14 mm; (b)(6) 204-70-00 - tibial stem ext.Screw.
Additional Manufacturer Narrative
D10 concomitant devices: (b)(6) 02-010-01-0240 - logic femoral ps cem left sz 4; (b)(6) 02-012-45-4040 - lgc tibial fit tray cem sz 4f / 4t; (b)(6) 200-02-35 - three peg patella 35mm; (b)(6) 204-34-02 - fluted stem extension 25l x 14 mm; (b)(6) 204-70-00 - tibial stem ext.Screw.The product associated with the reported event is within the scope of recall z-0021-2022; however, there is insufficient information to evaluate whether the subject issue of the recall was a cause or contributor to the reported event.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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated: h6 (type of investigation) the following sections were corrected: d4 (udi).H6 (health effect - clinical code, medical device problem code).The reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear and disassembly or due to inclusion of the polyethylene in the packaging recall.Potential contributions of user and patient-related considerations to the event could not be assessed as the devices were not available for evaluation and images and radiographs were not provided.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: LOGIC TIBIA PS MOD INSRT SZ 4 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 court; gainesville 32653
• Manufacturer Contact: geoff gannon ; gainesville 32653 ; 3523771140
• MDR Report Key: 19711474
• Report Number: 1038671-2024-02341
• Device Sequence Number: 15597315
• Product Code: JWH
• UDI-Device Identifier: 10885862001887
• UDI-Public: 10885862001887
• 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: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/03/2025

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: 02/21/2022
• Device Catalogue Number: 02-012-35-4009
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 07/09/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/09/2024
• Supplement Date Received by Manufacturer: 04/02/2025
• Initial Report FDA Received Date: 07/10/2024
• Supplement Report FDA Received Date: 04/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/24/2014
• 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): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female