MHRA issues medical alert over Comprehensive Nano Humeral Components

The Medical Health products Regulatory Agency (MHRA) has issued a medical device alert over Zimmer Biomet made Comprehensive Nano Humeral Components over risks of needing revision surgery when used in reverse configuration.

The manufacturer produced a medical device field safety notice earlier in June warning users of the less than accurate labelling on the devices.

The comprehensive ‘nano humeral component’ is usually used in the anatomic or reverse configuration, but after an annual review was conducted, the study data indicated the device was not fit for use in the reverse configuration.

The study found that, of 44 devices implanted in the reverse configuration, five needed revision surgery. Hospitals and clinics are instructed not to use the devices in the ‘reverse configuration’ but using it in the anatomic way is deemed safe for use and exceeds the expected performance rate. Zimmer Biomet is therefore carrying out a label correction with the updated instructions for the devices to only be installed one way.

The alert warns of the most adverse consequence to be exposing patients of risk of the installed device loosening, requiring further surgery to correct the fault. The following comprehensive ‘nano humeral component PPS devices’ are affected by the alert:

Doctors and physicians are encouraged to monitor patients who have had the device implanted in the reverse configuration and are experiencing some loosening more than two years of having the device fitted. Patients should be told to let their doctors know of “any increased pain or loss of shoulder movement or if their shoulder suddenly changes shape.”

For the patients, being implanted with an incorrectly configured device can be extremely disruptive. The pain and discomfort can prevent the patient from having full function of their shoulder and arm, making it difficult to work, lift or reach things.

For patients who need revision surgery, they will probably need to take time off to attend a hospital or clinic. The invasive surgery would not have been necessary if Zimmer Biomed had identified the fault earlier and either instructed doctors not to use the device in the ‘reverse configuration’ at all or only produce those that were fully functional both ways.

After the revision surgery, the patient may need time off to recuperate. Patients often forget they can claim financial compensation when a device has caused them harm to which they weren’t fully warmed about.

In this instance, those who were not warned that the implants could come loose and lead to revision surgery could claim for the pain, financial expenses and loss of amenity resulting from the implant.

This includes the costly trips to and from the hospital for the surgery and check-ups, taking time off work to attend these appointment and recovery, and even the help others have had to provide because of the patient’s loss of mobility.