Case Vignette – March 2021
Implant Breakage
Total hip replacements have been performed in one form or another for about a century. By comparison with current standards, the early implants were quite naïve and often failed rather quickly.
Professor Sir John Charnley made pivotal advances with material sciences and techniques in the 1960’s. He is recognised as being the modern father of hip replacement surgery.
Joint replacements do fail. Loosening, infection and wear are three of the possible causes.
During the latter part of the twentieth century, implant breakage was also a phenomenon that was recognised. It was never common but unfortunately, it did occur.
Understandably, civil actions sometimes ensued and the surgeon was deemed to be liable. In Australia, hip replacement devices are scrutinised by the Therapeutic Goods Administration and if deemed to be safe and acceptable, are listed on the Australian Register of Therapeutic Goods. Provided the surgeon involved uses the device as it has been designed (and not in a so-called “off market” mode), then the surgeon is probably guilt-free should that device subsequently fail.
The problem lies with the Therapeutic Goods Administration. Its charter obliges the organisation to be competent in the assessment of both the safety and efficacy of these medical devices. It is a gargantuan task and one that is not easily accomplished.
“PIC/S Guide to Good Manufacturing Practice for Medicinal Products, PE009-14, 01 July 2018
23 July 2020
Section 36 of the Therapeutic Goods Act 1989(link is external) allows the Minister for Health to determine Manufacturing Principles that are to be applied in the manufacture of therapeutic goods”.
The Australian Orthopaedic Association has a National Joint Replacement Registry which chronicles the performance of joint replacements. Quite often, under-performance can be recognised early (albeit in the post-market surveillance arena) and early signs of premature failure may be witnessed.
The National Joint Replacement Registry has become a most valuable tool for Orthopaedic Surgeons in Australia.
