MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIBIA PS MOD INSRT SZ 5 11MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-012-35-5011
Medical Device Problem Codes	Unstable (1667); Naturally Worn (2988)
Health Effect - Clinical Codes	Pain (1994); Ambulation or Postural Difficulties (2544); Joint Laxity (4526); Swelling/ Edema (4577); Aseptic loosening (4883)
Date of Event	12/15/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: 02-012-45-5050 - lgc tibial fit tray cem sz 5f / 5t, (b)(6), 204-34-04 - fluted stem extension 40l x 14 mm, (b)(6), 204-70-00 - tibial stem ext.Screw, (b)(6).H10: multiple mdr reports were filed for this event, please see associated report: 1038671-2023-00005.The reason for the revision in this event cannot be confirmed from the information provided but may be due to a combination of prosthesis wear and aseptic loosening between the femoral component and the bone as reported or may have been the result of patient conditions, implant sizing, or implant positioning issues.The loosening may have led to an increase in cement and bone particles in the joint space and resulted in prosthesis wear or prosthesis wear may have contributed to particle-induced osteolysis.A contributing factor to the alleged wear on the tibial insert may have been result of being packaged in a non-conforming vacuum bag for five years.However, the reported loosening and wear could not be confirmed as no images or radiographs were provided and the devices were not available for evaluation.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
Report #2 of 2 for this event.It was reported via legal documentation a patient had an initial right total knee arthroplasty.Subsequently, two (2) years late, the patient experienced pain, swelling, instability, bone loss, aseptic (non-infected) loosening and ambulation difficulties.As a result, the patient underwent a revision procedure of the femoral and tibial insert components.No further patient impact was reported.No additional information is available.

• Brand Name: LOGIC TIBIA PS MOD INSRT SZ 5 11MM
• 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: ashley harris ; 2320 nw 66th ct; gainesville, FL 32653
• MDR Report Key: 24530792
• Report Number: 1038671-2026-00233
• Device Sequence Number: 12985377
• Product Code: JWH
• UDI-Device Identifier: 10885862001931
• UDI-Public: 10885862001931
• 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: 2018
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/06/2026

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: 12/19/2021
• Device Catalogue Number: 02-012-35-5011
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/13/2022
• Initial Report FDA Received Date: 03/06/2026
• Date Device Manufactured: 12/20/2013
• 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 Sex: Male