Some Patient Groups Implanted with Birmingham Hip Resurfacing System™ Have Higher-Than-Expected Revision Rates

In a June 25 posting to the United Kingdom’s (U.K.) Medicines and Healthcare Products Regulatory Agency (MHPRA) website, the agency warns that some patient groups implanted with Smith & Nephew’s Birmingham Hip™ (BHR) Resurfacing system have been found to have higher-than-expected revision rates.

The alert is intended for medical directors, orthopedic departments, orthopedic surgeons and staff involved in the management of patients with joint displacement implants. These health care workers are warned in the alert not to implant the Birmingham Hip Resurfacing™ system in female patients and patients requiring femoral heads sized 46 mm or smaller, and to only use 48 mm BHR heads in the specific circumstance of intra-operative downsizing from a pre-operatively templated 50mm to a measured 48mm at the time of surgery.

The MHPRA alert instructs affected health care workers to return all unused Birmingham Hip Resurfacing™ femoral heads sized 46mm and smaller and their corresponding acetabular and dysplasia cups to Smith & Nephew, according to the alert. The agency all states that health care workers should follow up with all symptomatic patients, female patients and patients implanted with femoral head sizes 46mm and smaller, and issues the following management recommendations for the affected patient groups:

-Doctors and health care workers should follow-up with affected patient groups annually for the life of the implant.

-MARS and MRI imaging is recommended in all cases.

– A blood metal ion level test should be given to all affected patients.

-If the first blood metal ion level test shows a result greater than 7 parts per billion (ppb), a second test should be given three months after the first. It should be noted that a result of greater than 7 ppb indicates potential for soft tissue reaction, especially if greater than previously.

-Revision surgery should be considered if imaging tests are abnormal and/or blood metal ion levels are found to be increasing.

MHPRA also noted:

-MARS MRI scans are more important in decision making than blood ion tests alone.

-Patients with bone or muscle damage on MARS MRI tests are those of most concern. Unless an asymptomatic fluid collection around a joint is very large, it can be safely observed with interval scanning.

-Local symptoms include pain and limping.

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