MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIBIA FIN TRAY CEM SZ 3F/2T; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-012-39-3020
Medical Device Problem Codes	Unstable (1667); Loosening of Implant Not Related to Bone-Ingrowth (4002); Migration (4003)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Scar Tissue (2060); Osteolysis (2377); Ambulation or Postural Difficulties (2544); Joint Laxity (4526); Metal Related Pathology (4530); Swelling/ Edema (4577)
Date of Event	01/10/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information and/or investigation results shall be provided within 30 days of receipt.
Event or Problem Description
As reported via legal documentation, a patient had right knee replacement surgery on (b)(6) 2010.They underwent right knee revision surgery on (b)(6) 2023, approximately 12 years 7 months post primary procedure.Revision op report states that the knee was grossly unstable in all planes through the range of motion.The synovium was black from metal debris.The femoral component was well fixed and aligned/sized appropriately.The tibial implant was loose.The right tibial component was shifted into excessive posterior slope to motion of the implant and osteolysis at the fixation interface.The patellar implant was intact without significant wear, and remained well fixed.The mcl was absent.There is no other patient demographic or medical history available.There is no device return.There are no photos or other images of the device provided.No additional information is available.
Additional Manufacturer Narrative
The reason for the revision reported cannot be confirmed from the information provided but may be the result of loosening, prosthesis wear, instability, and subsidence, or due to inclusion of the polyethylene in the packaging recall.Additionally, these devices appear to have been implanted for over ten years prior to the reported event.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.D10 concomitants: (b)(6) 02-012-35-3009 - logic tibia ps mod insrt sz 3 9mm.(b)(6) 02-010-01-0330 - logic femoral ps cem right sz 3.(b)(6) 200-02-32 - three peg patella 32mm.H6: corrected health effect, medical device, component, and investigation clinical codes.

• Brand Name: LOGIC TIBIA FIN TRAY CEM SZ 3F/2T
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; gainesville 32653
• MDR Report Key: 18083748
• Report Number: 1038671-2023-02703
• Device Sequence Number: 15100884
• Product Code: JWH
• UDI-Device Identifier: 10885862002662
• UDI-Public: 10885862002662
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K932776
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2023
• 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): 01/22/2025

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/19/2015
• Device Catalogue Number: 02-012-39-3020
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/14/2023
• Supplement Date Received by Manufacturer: 01/22/2025
• Initial Report FDA Received Date: 11/07/2023
• Supplement Report FDA Received Date: 01/22/2025
• Date Device Manufactured: 01/21/2010
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10; SEE H11
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR
• Patient Sex: Female