Resurfacing Products withdrawn from the market2018-10-15T11:44:31+00:00

Resurfacing Products withdrawn from the market.

Resurfacing Products withdrawn from the market.

Resurfacing Products withdrawn from the market. On 4th June 2015, Smith & Nephew, the manufacturers of the Birmingham Hip Resurfacing (BHR) System announced the voluntary removal from the market of 46mm diameter & smaller femoral heads and the corresponding acetabular cup components for the Birmingham Hip Resurfacing (BHR) System. Smith & Nephew withdrew all smaller sized components and changed their instructions for use of the product, following analysis of recent performance data. Resurfacing Products withdrawn from the market.

Reason for Withdrawal of Birmingham Hip Resurfacing Products.
The withdrawal came about due to concern about the clinical performance of the BHR system in certain patient groups.  The conclusion reached was as follows:-

  1. The use of Birmingham hip resurfacing in female patients is to be contraindicated (i.e. it is not advisable due to a higher risk of complications)
  2. BHR femoral head components sized 46mm in diameter and smaller and their corresponding acetabular cup sizes are no longer to be used and are to be returned to Smith & Nephew.
  3. Patients requiring a 48mm femoral head size are at a moderately elevated risk of revision and should not be considered as candidates for Birmingham hip resurfacing implantation. A 48mm head should only be used in the specific circumstances of intra-operative downsizing from a pre-operatively templated 50mm to a measured 48mm at the time of surgery.

Statistical Data upon which the removal from the market was based.
This withdrawal from the market by Smith & Nephew was based upon a statistical analysis of the registry of data for the BHR system from the National Joint Registry of England & Wales, the Australian Orthopaedic Association National Joint Registry and the Swedish Hip Register.

Patients at greater risk.
The data suggested that the following patients are at greater risk of early revision than other patients:-

  1. Female patients.
  2. Male patients aged 65 and older.
  3. Patients requiring femoral head components 48mm in diameter and smaller.

What is resurfacing?
Hip resurfacing was developed as an alternative to total hip replacement. With a traditional total hip replacement the ball and socket of the hip joint are completely removed and replaced with implants. A metal ball (femoral head) with a stem is inserted into the thigh bone (femur) and an acetabular cup is inserted into the acetabulum socket (cup joint of the hip). The difference with the Birmingham Hip resurfacing procedure is that only two components are used, the acetabular cup and the femoral head.

The femoral head is not removed, as it is in the total hip replacement. Instead it is trimmed and resurfaced with a Birmingham hip femoral resurfacing head. This is hollow and is shaped over the femoral head. The acetabular socket is still removed and replaced with a BHR acetabular cup.  Both products are metal. The main difference between the total hip replacement and the Birmingham hip resurfacing is that more bone is preserved with a resurfacing.  For many years this was thought to be the better option for some individuals.

Birmingham Hip Total Hip Replacements.
R3 Acetabular System, On 1st June 2015, Smith & Nephew withdrew the optional metal liner within the R3 Acetabular System from the market.  This liner may have been used in stem total hip replacements and also with the Birmingham Hip Resurfacing head.  This product was withdrawn from the market following analysis of data collected from the UK & Australian patient joint registries.

The R3 liner is placed between the acetabular cup implant and the femoral head.  The metal liner is made of high carbide cobalt chrome (COCR).  It appears that problems may arise when the metal liner interacts with the metal femoral head component.  Hip replacements using the R3 metal liner are associated with higher than normal revision surgery rates which may present additional complications, for example, metallosis, etc.

Smith & Nephew Birmingham Hip Modular Head (BHMH).
On 28th January 2016, Smith & Nephew issued advice in relation to the performance of the Birmingham hip modular head (BHMH) in patients already implanted with the device. Smith & Nephew consider that the recipients of both the sleeved BHMH & monoblock BHMH are at a greater risk of revision surgery than previously anticipated.  Smith & Nephew ceased manufacturing the monoblock BHMH in 2008 and the sleeved BHMH was phased out in mid-2014. The risk of revision in both cases is above the UK’s National Instituted Health & Care Excellence Benchmarks.

Symptoms to be aware of in relation to implant failure may include:-

  • Loss of mobility.
  • Pain.
  • Inflammation.
  • Adverse local tissue reaction.
  • Dislocation.
  • Joint instability.
  • Broken bones around the components.
  • Leg length discrepancy.

Complications due to implant failure include.

  • Increased cobalt & chromium levels.
  • Necrosis, i.e., destruction of the bone around the metal product implant.
  • Metallosis – a type of metal poisoning.
  • Formation of pseudo tumours, a collection of fluid or tissue formation.

Malcomson Law currently represent clients / patients who have been required or require early revision surgery to remove hip implants. These patients all allege that they have suffered adverse reactions due to metal wear debris as a result of the metal on metal hip component.  They have suffered greatly in relation to their quality of life, the early failure of the hip resurfacing / replacement system and the necessity for further surgery.

If you have been affected or believe you have been affected by a Birmingham Hip Resurfacing Implant, then please contact one of our dedicated hip team Solicitors.

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