In 2010 the orthopaedic device company Depuy, a subsidiary of Johnson & Johnson, made a move to recall its Metal on Metal (MoM) ASR and ASR XL hip replacement systems from the international market. The recall of these product was due to an excessively high failure rate (Cohen 2011). The inability to simulate in situ conditions lead to the inability to design and implement and affect mean of hip arthroplasty devices. With over 93,000 devices installed the litigation resulting from the failure of this product is on going. The ASR and ASR XL hip replacement system returned a five year revision rate of 12%, in comparison to its main competitor the Birmingham hip which returned a revision rate of 4.3%. As a result the ASR and ASR XL device was subject to intense scrutiny, as a result exposing the medical device industry to the possible advantages and certain disadvantages of a Metal on Metal hip replacement system.
Introduction
In 2010 the orthopaedic device company Depuy, a subsidiary of Johnson & Johnson, made a move to recall its Metal on Metal (MoM) ASR and ASR XL hip replacement systems from the international market. The recall of these product was due to an excessively high failure rate (Cohen 2011). Initially brought onto the European market in 2003, the Depuy ASR and ASR XL system did not participate in clinical trials, as EU standards for a class IIb medical device did not require it (Cohen 2011). In the US the FDA asked Depuy to preform a clinical study called an Investigational device exemption (IDE). Although this premarket clinical study was carried out, and may have protected some patients form the ASR resurfacing system, the ASR XL system bypassed this study by means of exploiting the “similar equivalence” route throu...
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...ents with ASR or ASR XL hip replacements, showed in 26.1% of these patient reported serum cobalt concentrations of 7 µg/l (Langton et al. 2010). In comparison, reports claim that the BHR hip replacement resulted in a serum cobalt concentration of 4.3 µg/l. both concentration rported for the ASR, ASR XL and BHR device are over the concentration acceptable in humans.
Conclusion
To conclude, the failure of the Depuy ASR and ASR XL hip replacement systems is the result of many factors. The inability to simulate in situ conditions lead to the inability to design and implement and affect mean of hip arthroplasty devices. The relative lack of device longevity was related to design assumptions and the failure to observe several different issues regarding complexity and surgical ability, whilst focusing on having innovative production techniques and strong market share.
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is a widely diversified company in the field of health care and places a high value on holistic responsibility that serves as a defining component of their corporate philosophy. They believe that people who work in health care are responsible for the well-being of all others. This serves as the focus of J&J’s global business activities. Their products ranging from baby care, pharmaceuticals, products for quitting smoking, antiseptics, vaccines and a variety of medical devices touch the lives of over