Heraeus bone cement supply issue

As you will be aware, an issue has been identified with the packaging, and therefore the potential sterility, of the bone cement pouches manufactured by Heraeus. This affects all their cement products, including Palacos and Copal. As a result, newly manufactured Hereaus stock cannot be distributed and will be destroyed. Stock that has already been distributed is not affected. 

Current estimates indicate there is less than seven days’ supply of Heraeus-manufactured cement in the UK. Hereaus currently supply 82% of the market, slightly less in Scotland. It is expected to take at least two months for Heraeus stock levels to recover.  Other cement manufacturers are unlikely to be able to cover the shortfall, but those discussions are ongoing. The outcomes of these discussions may change guidance over the next few days.

There have been several meetings with all relevant stakeholders including BASK, BHS, BOA, BODS, OTS, NHS, Hereaus and others. NHS England, Department of Health and Social Care and BOA have released a joint statement. The devolved nations are expected to issue corresponding guidance imminently.

Due to the nature of cases and clinical priority, Heraeus will supply hospitals according to clinical priority and are looking at ways to re-distribute supply chains to hospitals with the greatest clinical need. They will also be working with other cement producers to help build up alternative supplies to support on-going surgery.

While individual hospitals retain responsibility for local operational decisions, BASK, BHS and OTS in conjunction with the BOA, support the following action plan:

1. Trauma is to be prioritised. Approximately 900 cemented implants are used to treat neck of femur fractures each week, which will require a large percentage of the available supply.
2. Oncology cases should be prioritised for whatever arthroplasty procedure is required.
3. Infected knee and hip revisions should be prioritised and treatment discussed and agreed at a regional MDTs. Where appropriate, the MRC will decide on cases and where these should be done.
4. P2 and P3 cases should be reviewed, and their priority status confirmed.
5. Consideration should be given to postponing P4 cases using cemented implants until supplies are re-established. Where hospitals do not use these gradings then cases should be assessed individually.
6. Surgeons may consider moving to an uncemented implants excluding hip hemiarthroplasty for fracture. BASK and BHS recommend this should be decided after discussion within a local MDT, full documentation within the medical records, discussion with the patient and re-consenting. Surgeons should not undertake surgery with new implants if unfamiliar with them.
7. All surgeons should be aware of variations in cement working time and viscosities if moving to alternative varieties as well as issues with using different cements in existing mixing apparatus.

This will be a challenging time for hospitals, surgeons, and patients, some of whom may experience delays to their surgery. It is essential that we work to direct resources to those with the greatest clinical need.

We will keep you updated with the situation.

Kind regards,

Alasdair Santini                Matt Wilson                      Xavier Griffin                     Fergal Monsell
BASK President                 BHS President                   OTS President                    BOA President