Exatech Total Knee System – Case Review – Defective Medical Device Cases

Objective:

Exactech, Inc. of Gainesville, FL is recalling their Optetrak Logic Posterior Stabilized Tibial Insert, Size 6 after the device was determined to be out of dimensional specification. Exactech, Inc., sent an “IMPORTANT PRODUCT MARKET WITHDRAWAL NOTICE” letter dated August 19, 2011, to all affected customers.

Indication:

The Optetrak Logic Total Knee System is indicated for use in skeletally mature individuals undergoing primary surgery for total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis, and/or post-traumatic degenerative problems. They are also indicated for revision of failed previous reconstructions where sufficient bone stock and soft tissue integrity are present.

Product:

There are three product sizes being recalled, 11mm, 13mm, 15mm. All other information is the same.

Reason for Recall:

Exactech, Inc. of Gainesville, FL is recalling their Optetrak Logic Posterior Stabilized Tibial Insert, Size 6 after the device was determined to be out of dimensional specification.

Defective Products:

The Exactech Optetrak knee replacement system was initially released to the market in 1994. According to the Exactech Optetrak lawsuit, the company became aware of the high rate of early failures with the knee implants as far back as April 2008. At that time, the company began designing a new tibial tray for the device in hopes that it would have corrected some of the issues that have been reported about the device.

Case Focus Blocks

  1. Medical and Surgical History: Medical issues directly or indirectly related to implant placement, Prior surgery, Placement of any implants – particularly knee complaints, surgeries
  2. Reason for Knee replacement – Need and Indication, Various Consultations, Patient right candidate for surgery? Preoperative Assessment
  3. Implant Placement Surgery: Detailed Operative Report, Post Operative progress notes, Entire Hospital Stay in detail (Can elaborate in discharge summary if discharge summary not available can elaborate/Give narrative summary on Post-operative progress notes, PT/OT records)

    Implant Details:

Knee Implant Surgery: Was the implant placed the same implant that is in question? If no communicate

Full Label Details of the implant to be included i.e. Name of implant, Manufacturer, Lot No., Reference No.

  1. Implant Failure/Complications:

What were the patient complaints? When was this first reported?

List of complications filed in the maude database includes:

  • Loose tibial component
  • Persistent Pain
  • Limited mobility
  • Knee swelling
  • Sensitivity due to loose joint
  • Visible loosening of device
  • Lack of ingrowth
  • Component failure
  • Globally tight knee
  • Instability or trouble balancing
  • Revision due to tibial loosening
  • Patella tracking issues
  • Fracture
  • Disassociation of implant
  • Inflammation
  • Change in component positioning – X-ray documentation

Medical Assessment and Diagnosis

Medical and Surgical Management of Complications

Whether the implant was removed? Appearance of the implant, operative findings, pathology report

Was another implant placed? If Yes, proceed to Focus Block No. 6

  1. Revision Surgery: Operative Report, Operative Findings documenting implant failure, Full Label Details i.e. Name of implant, Manufacturer, Lot No., Reference No., Post Operative progress notes, Entire Hospital Stay in detail (Can elaborate in discharge summary if discharge summary not available can elaborate/Give narrative summary on Post-operative progress notes, PT/OT records)
  2. Condition of the patient post revision surgery
  3. Complications Post Revision along with management (Include Dates of treatment and hospital patient received care)

Missing Medical Records:

Important records related to Knee implant case review to be communicated (Case focus blocks gives an idea on identifying critical missing records) (Missing records have to be identified and confirmed with TL and should be communicated to the client via reviewer’s comments)

  • Product details – Implant details, surgery details
  • Injuries
  • Damages

Matrix Evaluation Sample