MAUDE Adverse Event Report: EXACTECH, INC. OPTETRAK LOGIC; LOGIC CC FEMORAL SIZE 2, RIGHT

Model Number	02-010-06-0320
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bacterial Infection (1735)
Date of Event	06/03/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation.Concomitant medical devices: (cn: 02-012-45-2020, sn: (b)(4)) logic tibial fit tray cemented size 2f/2t.(cn: 02-012-60-1080, sn: (b)(4)) logic stem ext 10mmx80mm.(cn: 02-012-60-1080, sn: (b)(4)) logic stem ext 10mmx80mm.(cn: 02-012-65, 2025, sn: (b)(4)) logic cc tibial insert size 2, 25mm.
Event or Problem Description
As reported, this female patient has a charcot knee (neuropathic arthropathy) which is a disorder that causes progressive degeneration of a weight bearing joint including bony destruction, resorption, and deformity due to loss of sensation.Had multiple total knee surgeries over the course of her life.She developed an infection in her right knee, as well as fractured her tibia.Due to her disease and the fracture, the stem broke at the taper junction at the tibial implant.The female patient arrived at dr.(b)(6) clinic 3 months prior after a revision of a total knee, to an exactech optetrak cck, with a swollen knee.Due to having a charcot knee joint she is unable to feel pain and continued to walk on with a fractured tibia, as such she developed an infection and broke her implant at the tibial stem taper junction.Patient was last known to be in stable condition following the event.Devices are not returning.The patient was infected, and all implants were removed, an antibiotic spacer was implanted.This event took place due the charcot joint, infection and overall poor bone quality.These factors attributed to the tibial stem breaking, not a manufacturing error, or surgical error during the revision.The patient has a charcot joint of the knee, as such she has no feeling in the joint space, degeneration of the joint space and awkward weight bearing gate.Patient was last known to be in stable condition following the event.
Additional Manufacturer Narrative
Section h10: (h3) the evaluation of the revision based on review of all available information, there is no evidence to suggest that the reported event is related to any design or manufacturing issues.The cause of the infection and subsequent revision cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition.(d11) concomitant devices: (cn: 02-012-45-2020, sn: (b)(6)) logic tibial fit tray cemented size 2f/2t.(cn: 02-012-60-1080, sn: (b)(6)) logic stem ext 10mmx80mm.(cn: 02-012-60-1080, sn: (b)(6)) logic stem ext 10mmx80mm.(cn: 02-012-65, 2025, sn: (b)(6)) logic cc tibial insert size 2, 25mm.

• Brand Name: OPTETRAK LOGIC
• Common Device Name: LOGIC CC FEMORAL SIZE 2, RIGHT
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 10192652
• Report Number: 1038671-2020-00318
• Device Sequence Number: 3408450
• Product Code: JWH
• UDI-Device Identifier: 10885862265708
• UDI-Public: 10885862265708
• Combination Product (Y/N): N
• PMA/510(K) Number: K150890
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/02/2020

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: 09/10/2023
• Device Model Number: 02-010-06-0320
• Device Catalogue Number: 02-010-06-0320
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 06/04/2020
• Supplement Date Received by Manufacturer: 10/26/2020
• Initial Report FDA Received Date: 06/24/2020
• Supplement Report FDA Received Date: 12/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.
• Outcome Attributed to Adverse Event: Required Intervention