An alert sent out by the Medicines and Healthcare Products Regulatory Agency highlighted an issue with the cracking of the USS II Polyaxial 3D head rings that may result in the loosening of the spinal fixation system prior to completion of the bone healing.
The batch-related issue does not affect all devices, as Depuy issued a field safety notice on Nov. 13, 2019, to inform users of the potential intra-operative or post-operative cracking of head rings that can lead to the rods loosening, poor spinal mechanics, non-union or malunion, pain or dislocation.
Depuy reported that the majority of implant failures occurred and were identified during the procedure, but can happen post-operatively, so the warning applies to those with the fixation system already implanted, too.
The UK government urged those affected by the issue to identify and quarantine all affected devices within two weeks of receiving the medical device alert, which is dated today, July 10, 2020. Those affected should also complete follow-up with patients implanted with affected devices to see if symptoms of device failure are present.
Actions must be underway by July 24, 2020, and completed by Oct. 2, 2020.