Wrong Size/Wrong Site Prosthesis for Joint Replacements

The implantation of an incorrect size or wrong site prosthesis during joint replacement surgery is an avoidable surgical error that may result in significant harm to a patient. Evidence suggests that such incidents continue to occur and lead to a number of successful medical negligence claims.

A review of PMP cases notified over a six-year period identified that 27% related to orthopaedic surgery. The most common procedures involved knee arthroscopy and total knee replacements, including malposition of components.

“Never event”

“Placement of a prosthesis or implant different from that specified in the procedural plan, either before or during the procedure” is classed by NHS England as a “never event”. NHS England defines “never events” as: “patient safety incidents that are wholly preventable where guidance or safety recommendations that provide strong systemic protective barriers are available at a national level and have been implemented by healthcare providers”. The occurrence of a “never event“ is a failure of the process to ensure patient safety. Although a “never event” occurring may not result in harm to a patient, all must be investigated.

In an attempt to prevent these events, in 2009,  the World Health Organisations’ Surgical Safety Checklist was mandated in England and Wales. To reduce misunderstandings or errors and to improve team cohesion, NHS England developed the National Safety Standards for Invasive Procedures. This was revised in January 2023 by the Centre for Perioperative Care. These national standards cover all invasive procedures including those performed outside of the operating department.

Reporting on “never events”

NHS and private hospitals are required to maintain records of “never events” involving NHS funded patients, and report these to NHS England. The latter publish these figures on their website.

Any hospitals treating privately funded patients (including independent hospitals and NHS Private Patient Units) are required by the Competition and Markets Authority Private Healthcare Market Investigation Order 2014 (as amended) to report “never events” to The Private Healthcare Information Network (PHIN). The Order also requires PHIN to publish this data on a public website as performance measurements.

Incidence of wrong implant/prosthesis

22 never events were reported to PHIN by private providers between January 2023 and December 2023. This included 3 instances of wrong implant/prosthesis and 8 episodes of wrong site surgery.

A paper published by Harrison W D et al found that of 550 claims arising from orthopaedic operating theatres in England and Wales, 24 related to the implantation of an incorrect prosthesis, with a total cost of £2.9 million. Furthermore, the paper identified that wrong site surgery was the surgical error that resulted in the most successful litigation, with 89% of claims proving to be successful.

The UK’s Healthcare Safety Investigation Branch (HSIB) published a report in 2018 into the implantation of a wrong prosthesis during a total hip replacement in a 62-year-old male patient. During his surgery, incompatible prostheses made by different manufacturers were used. The error was identified when data from the procedure was recorded in the National Joint Registry several days later.

The patient was informed of the error, and it was reported to the relevant authorities as a serious incident. The hospital initiated an internal inquiry to understand how the error occurred. Expert advice was sought to determine if the patient required further surgery to replace the incorrect implant. After carefully considering all the relevant information, it was concluded that further surgery was unnecessary. The patient remains under review and will continue to be monitored.

The investigation focused primarily on hip replacement surgery; however, the findings are applicable to all orthopaedic joint replacements.

Factors identified by the investigation included:

• “Human factors which may hinder the identification and verification of the correct prosthesis.
• Variations in practice in how prosthesis verification is carried out by theatre teams.
• Existing standards for labels on prosthesis packaging are not sufficiently detailed to ensure labels can easily be read in the operating environment.
• A barcode scanning system could strengthen prosthesis verification.”

Barcode or radio frequency technology identification (RFID) technology which is used in industries such as aerospace and retail has been introduced into healthcare to improve patient safety. Barcodes are now being placed on implants to ensure that the right products are used with the correct patients, and that they can be traced in the event of a recall.

Recommendations to minimise the risk of wrong size/wrong site prosthesis for joint replacements

Please note, this is not an exhaustive list of recommendations; it represents the key learning points identified from the evidence discussed.

1. Ensure effective communication between all staff involved in the surgical procedure. 

2. Undertake a pre-operative briefing upon the patient’s arrival in the theatre with patient involvement (if possible) to verify the patient’s identity, consent, procedure and surgery site.

3. Site marking:

• Ensure the site of surgery is marked as close as anatomically possible to the incision site with an appropriate surgical-site marker.
• Ensure marking occurs before administration of sedation and/or anaesthesia.
• Involve the patient in marking the surgical site.
• Ensure that the mark is visible when the patient is positioned, prepped and draped.

4. Introduce “implant time out” to ensure the surgeon and theatre staff confirm the appropriateness of the prosthesis prior to implantation. 

5. Implement a scanning system to identify wrong prosthesis prior to surgical implantation. 

6. Ensure all details relating to the prosthesis, eg, size, site of implantation, manufacturer, expiry date, product code, etc., are recorded in the patient’s medical records. 

7. If an error occurs and the patient experiences an adverse outcome, it is important to investigate, explain and apologise to the patient. Please refer to the GMC’s “Openness and honesty when things go wrong: The professional duty of candour.” If a patient suffers an adverse event or you receive a complaint from a patient, please notify PMP as soon as possible.

• In addition, when a notifiable safety incident has occurred, the healthcare provider must comply with the statutory duty of candour.