Case details

Profemur R’ hip implant was defective, patient alleged

SUMMARY

$4500000

Amount

Verdict-Plaintiff

Result type

Not present

Ruling
KEYWORDS
fracture, hip, hip replacement, leg
FACTS
On Nov. 27, 2007, plaintiff Alan Warner, 63, had a “Profemur R” prosthesis implanted to replace his artificial hip. Three years later, on Oct. 27, 2010, he was walking in his home when he suddenly felt severe pain in and around his left groin. He was unable to walk and immediately lay down. The following morning, he presented to Cedars Sinai Medical Center and was diagnosed with a left femoral stem fracture. At the hospital it was determined that the Profemur R implant had snapped at the stem. The Profemur R femoral component (serial no. 037409895) was manufactured by Wright Medical Technology Inc. A few days later, on Nov. 1, 2010, Warner underwent revision surgery performed by Brad Penenberg, M.D., whereby the entire left-hip implant system was revised again. On Feb. 1, 2011, the revised hip-implant system failed, when the acetabular component did not take to Warner’s pelvis, causing an anterior dislocation and resulting in subsidence of the femoral component. On the same day, Warner presented to the Cedars Sinai Medical Center emergency department, where he was admitted. The following day, he underwent a closed reduction of the hip under general anesthesia. The physicians believed that his hip was still unstable. On Feb. 7, 2011, Warner again underwent a revision of his total hip implant system, but from a different manufacturer. Warner sued Wright Medical Technology Inc., Wright Medical Group Inc., Brad L. Penenberg, M.D. and Harlan C. Amstutz, M.D. (Only Wright Medical Technology continued as a defendant to trial, as all other defendants were either dropped or removed from the case.) He alleged products liability claims of manufacturing and design defects and failure to warn. Warner contended the implant broke at a laser orientation mark which physicians use to orient the device during surgery. He alleged the laser mark was burned too deeply into the device, which resulted in the titanium alloy which the device was made of to melt and re-solidify as Aluminum Oxide, making it brittle and more prone to corrosion. Warner also argued that as a result, the device’s microstructure was altered and the device could no longer withstand stresses and loads it was designed to during normal patient use. Specifically, plaintiff maintained that laser engravings deeper than 35 microns can cause the titanium in metal implants to become brittle, and that the crack in Warner’s Profemur R emanated from a laser mark more than 100 microns deep. The defense asserted that the break resulted not through a defect in the implant, but because the top of the implant was not properly affixed to Warner’s existing bone. The defense contended that Penenberg could have selected a larger-sized implant system, which would have been a better fit for Warner. Warner claimed that Penenberg was sought by Wright to use its implants and to train other surgeons and that he no longer uses the implant since he learned of Warner’s fracture. The defense asserted this was a one-off case involving part-components with a strong track record of clinical success. The system is unrelated to ongoing consolidated litigation involving metal-on-metal hip-prosthesis cases., Following the fracture, Warner experienced a number of dislocations and prolonged infections, which required 14 major surgeries. Alan Warner’s wife, Patricia Warner, sought recovery for her claim of loss of consortium.
COURT
Superior Court of Los Angeles County, Van Nuys, CA

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