MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIBIA IMPLANT PSC INSERT, SZ 6, 13MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-012-44-6013
Medical Device Problem Codes	Mechanical Problem (1384); Naturally Worn (2988); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Pain (1994); Loss of Range of Motion (2032); Discomfort (2330); Osteolysis (2377); Ambulation or Postural Difficulties (2544); Balance Problems (4401); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	05/14/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10 concomitant devices: (b)(6), 02-022-45-6060 - truliant tib fit tray cem sz 6f / 6t, (b)(6), 02-010-01-0360 - logic femoral ps cem right sz 6, (b)(6), 200-02-38 - three peg patella 38mm, (b)(6), 201-78-12 - holding pin lg head sharp point med 2pk.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.
Event or Problem Description
It was reported via legal documentation that approximately 42 months after a right total knee replacement procedure, the patient has experienced prosthesis wear, joint pain, joint swelling, joint stiffness, limited range of motion, loss of mobility, muscle tissue damage, tissue damage, device failure necessitating painful revision surgery; limited activities, daily pain and discomfort in left knee impacting quality of life.Significant pain and discomfort, gait impairment, poor balance, difficulty walking,; component part loosening, soft tissue damage, bone loss, and other undiagnosed injuries requiring ongoing medical care.Future damages also including but not limited to cost of medical care, rehabilitation, home health care, loss of earning capacity, mental and emotional distress, loss of consortium and pain and suffering.No further issues or complications were reported.No additional information is available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The reason for the reported event cannot be confirmed from the information provided but may be due to prosthesis wear, loosening and loss of range of motion.And/or inclusion of the polyethylene in the packaging recall.Potential contributions of manufacturing, user and patient-related considerations to the event could not be assessed as the devices were not available for evaluation and images, radiographs, relevant clinical information and product information 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 IMPLANT PSC INSERT, SZ 6, 13MM
• 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: 19837451
• Report Number: 1038671-2024-02555
• Device Sequence Number: 6598191
• Product Code: JWH
• UDI-Device Identifier: 10885862173874
• UDI-Public: 10885862173874
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K110547
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/28/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/16/2024
• Device Catalogue Number: 02-012-44-6013
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/22/2024
• Supplement Date Received by Manufacturer: 04/25/2025
• Initial Report FDA Received Date: 07/26/2024
• Supplement Report FDA Received Date: 04/28/2025
• Date Device Manufactured: 06/16/2016
• 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
• Patient Sex: Male