NJR cite DePuy hip replacement recall as proof patient safety system works

7 September 2010 

The National Joint Registry (NJR) – the programme established in 2002 to monitor surgeon and implant performance in relation to hip, knee and ankle replacement services in England and Wales – has cited the recall and Medical Device Alert regarding DePuy Orthopaedics’ ASR hip replacement device as firm proof its ongoing analysis of implant recipients is aiding patient safety. 

NJR Project Lead Elaine Young highlighted the vital role the National Joint Registry (managed by HQIP) played in identifying the problem: “The NJR was established to ensure joint procedures and their resultant effectiveness were not only closely monitored, but transparently reported on, with action swiftly taken where necessary to ensure patient safety,” Young said. “Once DePuy’s ASR device was identified by the NJR as a potential outlier, the NJR acted in accordance with its outlier process and referred this to the MHRA for further investigation. This was a clear example of the success and benefit of the Registry and precisely why it was originally established.” 

The NJR database currently contains more than 905,000 records, and is the largest database of its kind in the world. According to its statistics, a total of 563 patients in England and Wales were fitted with one of DePuy’s ASR devices in 2009, at 108 hospitals across 69 NHS Trusts, according to the NJR Annual Report for 2009, which is set to publish on 15 September 2010.  

These numbers down from 2008 figures which reported 917 patients fitted with DePuy’s ASR devices at 105 hospitals across 61 Trusts. 

The NJR team identified the ASR device as a potential ‘outlier’ (falling below accepted standards of performance) in April 2010, as part of the ongoing quarterly outlier monitoring schedule. In accordance with procedure, this information was immediately reported to government body the Medicines and Healthcare products Regulatory Agency (MHRA). 

Following ongoing monitoring from DePuy and MHRA, the manufacturer issued a Field Safety Notice recalling all ASR his replacement implants on 24 August 2010. Further to this MHRA has today (7 September 2010) issued a Medical Device Alert, which states: “[DePuy] has now determined that the revision rate for all devices in the ASR systems at five years is higher than expected across the entire size range... Following consultation with our orthopaedic experts we are updating the advice provided in MDA/2010/044 to ensure appropriate follow-up is considered for all patients already implanted with these hip replacement implants”.