In this article, Mark McCullagh, Clinical Risk Adviser, highlights the risk of implanting the wrong side or size prosthesis during orthopaedic surgery, and discusses international experience and risk mitigation.
The implantation of an incorrect side or size prosthesis during orthopaedic surgery is an avoidable surgical error, which can cause significant patient harm, entail revision surgery and may result in litigation. In addition to the effects on the patient and the clinical staff involved, implantation of the incorrect prosthesis during orthopaedic surgery can cause severe reputational damage to the healthcare institution.
Orthopaedic implants are designed to function in either a left or right limb and are manufactured in various sizes. The State Claims Agency (SCA) is managing a number of claims against Irish hospitals in which the wrong side component or wrong size component was inserted in the course of a total hip arthroplasty (THA) or total knee arthroplasty (TKA) joint replacement procedure. This type of incident is potentially a Category 1C Serious Reportable Event (SRE) as defined by the HSE, i.e. wrong surgical procedure performed on a patient by a healthcare service provider.1
A review of 550 claims relating to consent and non-technical errors (i.e. patient safety failures) in orthopaedic operating theatres in England and Wales found that 24 claims with a total cost of £2.9 million (€3.4 million) related to implantation of an incorrect prosthesis.2
Case reports documenting wrong side orthopaedic implants have also been published. A UK report involved the insertion of a left femoral component into a right knee during TKA in a 72-year-old woman.3 This patient required revision surgery. In another case from Saudi Arabia, a right femoral component was inserted into the left knee during TKA in a 72-year-old woman.4 In this case, the left knee was described as ‘functioning well’ and no further surgery was undertaken.
The UK’s Healthcare Safety Investigation Branch (HSIB) published a report in 2018 into the implantation of a wrong prosthesis during THA in a 62-year old-man.5 In this case, which required the implantation of four components, the second two components were from a different manufacturer to the first two. The error was identified when details were entered into the National Joint Registry. Further surgery was judged unnecessary and the patient remains under regular review.
It has been reported that the majority of cases of wrong-site surgery in orthopaedics involved communication breakdown.6 It is likely that wrong side / wrong size orthopaedic implant incidents involve miscommunication within or between hospital multi-disciplinary teams.
A number of solutions to reduce the risk have been proposed:
- The introduction of an ‘implant time out’ to ensure the surgeon and theatre staff confirm the appropriateness of the prosthesis prior to implantation2
- The implementation of a scanning system to identify wrong prostheses prior to surgical implantation5
Wrong side / wrong size orthopaedic implant incidents are avoidable errors which have the potential to cause harm to patients and require further surgery, and may result in litigation. International evidence and SCA experience suggest that these incidents are not as uncommon as might be expected. Risk mitigation strategies include a greater focus on communication around selection of prosthetic components and adoption of electronic patient safety solutions.
References available on request.
Clinical Risk Insights
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