Medicines and Healthcare products Regulatory Agency

5. Mrs H complains the MHRA concluded the failure of her knee replacement was not worth following up despite her investigation work, the wear affecting the insert and the consequences of this.

6. Mrs H also complains the MHRA reached this decision due to the manufacturer’s investigation. Mrs H is therefore concerned the MHRA did not apply its rigorous standards to its assessment.

7. Mrs H explains as a result of the above she is left with an extreme increase of zirconium (a metal) in her blood, leading to multiple medical complications.

8. Mrs H wants financial compensation to make up for stress, fatigue and reduced quality of life. She also wants the MHRA to apply a higher standard when considering cases.

9. In September 2016 Mrs H had a knee replacement operation. However, over the next few years she continued to experience problems with her knee until, in 2019, it was discovered the replacement joint was broken.

10. In February 2019 Mrs H had a second operation. After this, she contacted the MHRA about what had happened. The MHRA asked the joint manufacturer to investigate the incident.

11. In July 2020 the MHRA told Mrs H the manufacturer had completed its report. It said it would be asking the manufacturer to release the report to Mrs H. (The MHRA later explained that, although it had received a copy of the report, it could not release it without the manufacturer’s permission.)

12. On 16 September 2020 the manufacturer sent its incident report to Mrs H. It said it had no reason to suspect the products had failed to meet any product specifications at the time of manufacture. It said a relationship, if any, between the devices and the reported incident could not be corroborated.

13. The following day Mrs H’s husband, Mr H, acting on her behalf, contacted the MHRA to raise concerns about the report. The MHRA responded to say Mr H had ‘raised some pertinent points’ and the MHRA would be challenging the manufacturer to prove that its investigation had been thorough. The MHRA pointed out it did not regulate healthcare professionals or clinical practice. It gave Mrs H a list of other organisations that may be able to help. Our office was one of the organisations the MHRA mentioned (it said we made final decisions on complaints NHS England, UK government departments and other public organisations had not resolved).

14. In December 2020 Mrs H complained to the MHRA about what had happened. The MHRA responded on 26 January 2021. It recognised there had been some delays in passing the incident details to the manufacturer, but overall it was satisfied it had handled the case appropriately. The MHRA said if Mrs H was unhappy with the MHRA’s decision, she could ask for a review (within two months). It added if she was still unhappy following the review, she could bring her concerns to our office via her MP.

15. In February 2021 the MHRA wrote to Mrs H again. It said it had reviewed the manufacturer’s incident report and was satisfied with the outcome and with the way the incident had been investigated. It said it had no evidence of a wider problem with the device or that any risks it presented outweighed any benefits.

16. In March 2021, following further contact from Mrs H, the MHRA wrote to say it had issued its final response and now considered the matter closed.

17. In June 2022 Mrs H contacted her MP’s office and asked for her concerns to be forwarded to our office.

20. According to paragraphs 5(1)(a), 5(1)(b) and 6(3) of the Act, a person needs to make their complaint in writing to an MP within a year of becoming aware of the problem. We cannot investigate complaints brought to an MP after one year unless we consider there is a good reason to do so.

21. Given the ongoing nature of her concerns about the incident report, it is not entirely clear when Mrs H first had cause to complain to an MP about what had happened. However, by December 2020 she knew she had cause to complain to the MHRA, and by January 2021 the MHRA had responded to that complaint. In that response, the MHRA explained clearly what steps Mrs H needed to take if she was still unhappy. These included making a complaint to our office. Despite this, Mrs H did not bring her complaint to her MP in writing until June 2022. This is outside the timescale set out in law.

22. We have looked carefully at Mrs H’s reasons for why she could not bring her complaint to us earlier. In her initial contact with our office (her complaint form dated 16 June 2022) she said she had been unaware of our office until that point. While we do not wish to dispute what she has said about this, the evidence we have seen does not support what she has told us.

23. As we said earlier, the MHRA made Mrs H aware of our existence and purpose as early as September 2020. Although we accept it may not have been clear from the MHRA’s correspondence she could complain to us about that organisation, the MHRA clarified this when it wrote to Mrs H in January 2021 in response to her complaint. At that point it clearly explained what steps Mrs H needed to take to escalate her concerns. Mrs H did not follow those steps and that is why her complaint fell outside our time limit.

24. We have decided to take no further action on this complaint. This is because it was made outside the legal time limit and we have seen no good reason to set that time limit aside.

25. We were sorry to learn of the circumstances that led to Mrs H’s complaint. We have no doubt the failure of Mrs H’s knee implant would have had a significant and life-changing effect on her. We realise this is unlikely to be the outcome Mrs H was looking for when she approached us and we can understand her frustration. We thank her for bringing her concerns to our attention.

1. The Parliamentary and Health Service Ombudsman has carefully considered Mrs H’s complaint about the Medicines and Healthcare products Regulatory Agency (MHRA).

2. We were sorry to learn of the events that led to Mrs H’s complaint and can understand her frustration and the impact the events have had on her.

3. Having carefully considered matters, we have decided to take no further action on this complaint. This is because the complaint falls outside our time limit and we have decided there is no good reason for us to put our time limit aside to consider it further.

4. The following paragraphs explain our decision in more detail.