Depuy Evaluation Criteria

 

1.         Medical and Surgical History:

Medical issues directly or indirectly related to implant placement, prior surgery, placement of any implants – particularly hip complaints, hip surgeries

History of:

Hip Complaints

Non-inflammatory degenerative joint diseases, including osteoarthritis and avascular necrosis;

Rheumatoid arthritis;

Functional deformities;

Prior Implant Placement or Revision procedures

Treatment of non-union, femoral neck and trochanteric fractures of the proximal femur with head involvement unmanageable using other techniques

 2.       Hip Implant Consultation

Need and Indication

Various Consultations

Whether patient right candidate for hip implant placement?

Preoperative Assessment

 3.       Implant Placement Surgery:

Detailed Operative Report

Post Operative Follow up

Entire Hospital Stay in detail

Implant DetailWas the implant placed the same implant that is in question – If not report

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

4.       Implant Failure:

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

Joint loosening/dislocation

Device wear and tear, such as corrosion and fretting

Broken Devices

Excessive metal debris leading to metal ion generation (blackened flesh)

Inflammation of tissue

Hypersensitivity/allergic response

Metallosis

Hip Pain, difficulty climbing stairs and difficulty in hip flexion

Joint – Popping, Squeaking, Weakness, Clicking

Lumps or pseudo-tumors, under the skin

Labs – Cobalt and Chromium levels before and after the revision surgery – Note and highlight elevated levels

Diagnostic Tests / X-rays of Hip implant failure

5.       Implant Failure Management

Medical Assessment and Diagnosis

Medical and Surgical Management of Complications

Whether the implant was removed?

Revision Surgery: Operative Report, Operative Findings documenting implant failure, Post Operative Follow up, Entire Hospital Stay in detail

Appearance of the implant, pathology report

Was another implant placed? Revision implant details

Revision Implant Details: Full Label Details i.e. Name of implant, Manufacturer, Lot No., Reference No.

 6.       Was Revision Surgery successful?

 7.       Condition of the patient after the revision surgery

Missing records notification to Client related to

  • Hip Implant Label Details, Placement Procedure Details, Complication Details, Revision Details