- Defective Hip Implant/Failure of Hip Implant
- “Fretting and Corrosion” of Metal Implants near the modular neck junction
- Leads to Complications, Injuries, Metallosis, Need for Revision Surgery
- Voluntary Recall of Rejuvenate Modular Hip System and ABG II Modular-Neck Hip Stem
Areas to be focused in Medical Records Review
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
Non-inflammatory degenerative joint diseases, including osteoarthritis and avascular necrosis;
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
Whether patient right candidate for hip implant placement?
3. Implant Placement Surgery:
Detailed Operative Report
Post Operative Follow up
Entire Hospital Stay in detail
Implant Detail: Was 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?
Device wear and tear, such as corrosion and fretting
Excessive metal debris leading to metal ion generation (blackened flesh)
Inflammation of tissue
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