MAUDE Adverse Event Report: EXACTECH, INC. OPTETRAK LGC TIBIAL FIT TRAY CEM SZ 3.5F / 3.5T; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-012-45-3535
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Pain (1994); Osteolysis (2377); Joint Laxity (4526)
Date of Event	10/07/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, approximately 4 years and 10 months post initial total knee arthroplasty (tka), the patient experienced pain in the operated knee.During examination, the patient had multidirectional instability of the knee.In radiological study, the image was compatible with polyethylene wear, wear of the patellar component, massive osteolysis in relation to the tibial component, and tests compatible with aseptic disimplantation.The patient had normal blood metal levels.It was further noted that the patient experienced significant disability and surgical revision was performed to avoid injury or permanent disability.No further information is available at this time.
Additional Manufacturer Narrative
The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Concomitants: (b)(6), 02-012-35-3509 logic tibia ps mod insrt sz 3.5 9mm; (b)(6), 200-02-32 three peg patella 32mm; (b)(6), 02-010-01-0235 - femur ps cem.Nº3.5 izq.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information: please disregard this report as it was submitted in error.Event was previously reported under report # 1038671-2025-00376.

• Brand Name: OPTETRAK LGC TIBIAL FIT TRAY CEM SZ 3.5F / 3.5T
• 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: geoff gannon ; 2320 nw 66th ct.; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 21161427
• Report Number: 1038671-2025-00268
• Device Sequence Number: 8539150
• Product Code: JWH
• UDI-Device Identifier: 10885862003997
• UDI-Public: 10885862003997
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K101981
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/13/2025

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 Catalogue Number: 02-012-45-3535
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/08/2025
• Supplement Date Received by Manufacturer: 03/13/2025
• Initial Report FDA Received Date: 01/15/2025
• Supplement Report FDA Received Date: 03/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/12/2017
• 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: Disability; Required Intervention
• Patient Sex: Unknown