A regulator warning earlier this year stemmed from bone cement complications caused by an issue with the product itself.
A risk of the need for revision surgery from the use of Optipac 40 Refobacin Revision and Optipac 80 Refobacin Revision was identified. Manufacturer, Biomet UK Limited, issued a Field Safety Notice at the end of last year. The UK’s medical regulator, the MHRA (Medicines and Healthcare products Regulatory Agency), issued their own recall advice off the back of the findings.
Anyone who has suffered with bone cement complications may find the reason is to do with the product itself as opposed to failed surgery.
Bone cement complications arising from recall
The bone cement complications arising from the recall mean that the mechanical strength of the affected batches of cement may be reduced. This means there’s a risk of a patient being forced to undergo revision surgery.
There’s also the risk of surgery being prolonged as a result of increased polymerisation time when using the recalled batches. In short, this means the cement isn’t ‘setting’ quickly enough as a result of the problems identified.
As a result of the bone cement issues identified, surgeons have been instructed to create risks assessments and follow-up plans for affected patients.
Have you been affected by the bone cement complications?
If you’ve had to have revision surgery or had prolonged surgery as a result of the bone cement complications, we may be able to help you.
Particularly in cases where revision surgery is required, there may be a claim for personal injury compensation. The simple fact is that the need for revision surgery has stemmed from the product problem.
You can contact our team for help and advice today.
In medical defect cases, claiming compensation for the need for further surgery can be common. This was a common factor in the PIP breast Implant litigation that we’ve so far recovered over £1.3m in damages for. Women were required to have new implants fitted and the defective ones removed.
Products linked to the bone cement complications
The specific products linked to the bone cement complications and the MHRA recall are as follows:
| Catalogue number (Manufacturer product code) | Product Description | Batch/Lot number | Use-by date | Date of manufacture |
| OPTIPAC 40 REFOBACIN REVISION | 4730501163-1 | A648C04670 | 31/05/2018 | 19/12/2016 |
| OPTIPAC 40 REFOBACIN REVISION | 4730501163-1 | A648C05100 | 30/06/2018 | 09/01/2017 |
| OPTIPAC 40 REFOBACIN REVISION | 4730501163-1 | A705B05130 | 31/07/2018 | 09/02/2017 |
| OPTIPAC 40 REFOBACIN REVISION | 4730501163-1 | A705B06130 | 30/09/2018 | 04/04/2017 |
| OPTIPAC 40 REFOBACIN REVISION | 4730501163-1 | A722B08920 | 30/11/2018 | 20/06/2017 |
| OPTIPAC 80 REFOBACIN REVISION | 4732501165-1 | A620A01788 | 31/01/2018 | 16/08/2016 |
| OPTIPAC 80 REFOBACIN REVISION | 4732501165-1 | A620A0178A | 31/01/2018 | 23/08/2016 |
| OPTIPAC 80 REFOBACIN REVISION | 4732501165-1 | A705C05628 | 31/08/2018 | 30/03/2017 |
| OPTIPAC 80 REFOBACIN REVISION | 4732501165-1 | B705B05128 | 31/07/2018 | 09/02/2017 |
Information from MHRA Website.
First published by Author on November 09, 2018
Posted in the following categories: Medical Products Recalls and tagged with device alerts | medical devices | medical implants | medical product | medical recall | mhra | recalls