DePuy Tibial Baseplate Malfunction

The tibial baseplate of the DePuy artificial knee is defective, malfunctions and can cause severe injury

Monday, June 18, 2018 - The DePuy Knee Replacement Device has experienced an unexpectedly high failure rate requiring revision surgeries to replace the tibial baseplate and then reattach the knee device to the shinbone. So many problems have been reported that the company, DePuy Synthes, has invented a new knee device to specifically address the tibial baseplate issues. In so doing the company acknowledges the knee devices early failure and seeks to capitalize yet again on their patient's suffering. Patients that are experiencing severe pain and immobility as a result of premature tibial baseplate loosening are encouraged to consult a DePuy knee replacement attorney to see if they qualify to seek compensation. It is for this reason and others that a Florida man has filed a defective knee system lawsuit seeking compensation for his failed DePuy knee.

According to the Florida Record newspaper, a West Palm Beach, Florida man has filed a claim alleging that the DePuy knee that he received in March 2014 caused him severe pain immediately after the surgery and continually afterword due to the loosening of the "defective tibial baseplate." The complaint stated, "The success rate of a revision surgery is much lower than that of the initial total knee replacement and the risks and complications are higher, including limitations in range of motion, the ability to walk, and even death." The plaintiff is seeking over $75,000 in compensatory damages. (1)

Patients were told to expect the DePuy knee replacement device to have a life of 15-20, not the 1-5 that some are experiencing. As a result of numerous patient complaints, DePuy was forced to issue a Class II recall of the Articulation Surface component of the tibial baseplate device. The manufacturer's reason for the recall was the "potential for the Balseal, a small wire spring coil located on the post feature of the Knee Tibial Articulation Surface Instruments used in trailing to become damaged and disassociate (come off). If the Balseal is separated from the post, it has the potential to enter the surgical site and be left in the patient if the surgeon is unaware of the disassociation." (2) According to the FDA, a Class II is when the defective medical device produces, " - a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote." Nowhere is there consideration made for the risks associated with revision surgery or the probability that the new knee device will fail based on the patient's weakened condition.

Tibial baseplate detachment from the tibia not only results in excruciating pain and immobility but also can cause the shin bone to wear and chafe as a person walks. The irritation, in turn, can lead to infections and make removal of a section of the shin bone necessary to facilitate the new knee replacement device. DePuy admits this and the new revision knee device makes adjustments to compensate for shin bone loss.

(1) https://flarecord.com/stories/511454065-depuy-synthes-facing-suit-for--knee-replacement-failure

(2) https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=137734

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