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White v. DePuy8/17/1998
cluded that there were "several factors working against her" that would encourage more rapid deterioration, including (1) "her young age and expected higher activity level," (2) the mismatched ball and socket, (3) the relatively small size of the socket used in White's replacement ("there was a lot less room to have polyethylene in there"), (4) her specific initial ailment, which was diagnosed as polymyositis, (5) a prior infection of her hip region which made her a "compromised host," and (6) the possibility of a defective polyethylene liner. Fox admitted, however, that he is not an expert in the failure analysis of hip prostheses. Instead, he is an orthopedic surgeon who has some "basic information and knowledge" of why a replacement hip would fail.
The worn liner removed from White was, apparently, misplaced or discarded by Fox, and is thus unavailable for inspection. Fox testified that during White'srevision surgery, he observed that "[White's] socket had a deficient portion. The polyethylene was worn and was split." A metal rim or marker around the polyethylene was also split and part of that was completely worn away. "The metal ball had gone into the lateral side of the metal socket and worn into that to a degree almost to the point where it was through and through the socket."
Fox also described the condition of the prosthesis after he removed it from Gloria White:
" he polyethylene liner was split had a wear trough across it, so instead of having a spherical base it had an oblong base. * * * Through and through, through the side, going right through the side of the thing. So there was a trough running through the side of the acetabulum. It wasn't a spherical wear and it was central wear as well as lateral wear. * * * he way it looked is that it was beyond what I could account for just with normal wear and tear. It was not normal to see this. In retrospect, at this point knowing the mismatched size femoral head and socket, that contributed somewhat to the wear pattern, but in retrospect also the polyethylene problem that occurred with DePuy implants was at that time, my feelings were, it was the cause of the excessive wear. * * * Not the wear of a mismatch. * * * And my conclusions were that the failed defective implant was the cause of it, the excessive wear. The defective polyethylene was the cause of excessive wear.
" he polyethylene wear pattern was not a normal wear pattern. It happened too rapidly, and it happened eccentrically * * *. rom my standpoint it was beyond what would have been expected in a 45 or 42 or 40-year-old-hip that was five years since its inception. Based on * * * my knowledge that there was some information about the defectiveness, the defective sockets, plastic polyethylene bearings that had been alluded to by the detail people or representatives of DePuy and published in the meetings * * * . I concluded that the polyethylene was the source of this at the time of the surgery. Subsequent to that, having seen at this point that there was a mismatch in size, there was a combination of factors. If there hadn't been a defective polyethylene, would it have worn as quickly? I don't know that there's a way of answering that. My knowledge of it is such that this lasted for two years before it showed any signs of wear, okay, despite the mismatch in size."
By comparison, the March 9, 1990 recall announcement issued by DePuy states that the failure of the defective liners appears as a "breaking of the polyethylene liner immediately beneath the rim/body interface in the superior position of the implanted cup." The letter further states that " fter failure, the polyethylene shell may rotate inward * * * exposing the metal of the acetab
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