Artificial knee components may be subject to loosening after knee replacement surgery using Stryker bone cement, according to a recent lawsuit filed on Oct. 12, 2018.

The Stryker bone cement complaint was filed by plaintiff Frank N., a former total knee arthroplasty (TKA) patient, in Kentucky. Frank is a citizen and resident of Louisville located in Jefferson County.

The plaintiff brings his legal claim against the developers, manufacturers, promoters, and distributors of the DePuy Attune knee and Simplex HV bone cement. The defendants include Depuy Synthes Sales Inc., Depuy Orthopaedics Inc., Johnson & Johnson, Stryker Corporation, Howmedica Osteonics Corporation, and  AAP Implants Inc.

Frank was subject to the use of Stryker bone cement known as Simplex HV bone cement—the HV standing for high viscosity—on Nov. 16, 2015.

The plaintiff says he was was implanted with a DePuy Attune knee prosthetic on his right side and the Stryker bone cement was used to bond the tibial plate into the lower leg bone. The tibial plate is the resting surface upon which the entire prosthetic mechanism rests and functions.

Two years and three months later on Feb. 19, 2018, Frank says he had to have an additional surgery on his replaced knee, which is commonly referred to as a knee revision. He says that in his case, the entire prosthetic had to be removed and replaced because of aseptic—without infection—tibial loosening.

Frank attributes the loosening to use of this defective Stryker bone cement, which he says had been aggressively advertised by the defendant as safe and superior.

Stryker Bone Cement and the 510(k) Review

Stryker Simplex HV bone cement was approved by the U.S. Food and Drug Administration (FDA) through their 510(k) review, which is essentially a shortcut for drug and device manufacturers.

Utilizing this controversial loophole in the law, the cement hasn’t had to prove itself as safe and effective in clinical trials, but rather that it is essentially equivalent to a product already marketed that has proven itself.

According to the legal complaint, the defendants had previously indicated that their non-HV bonding cement called Simplex P was stronger and safer than other HV bonding cements available from their competitors.

They purportedly indicated in a 2008 brochure that HV products could not be pressurized into bone as efficiently as light to medium viscosity cements. Yet, this promotion was quickly overrun when they set about to develop their own HV version.

The HV product was then advertised aggressively. Frank indicates that this inconsistency reveals deliberate subterfuge on the part of the medical device maker — DePuy.

The legal complaint indicates that he could have been saved the pain and suffering of the Stryker bone cement failure and subsequent tibial loosening if DePuy had been forthright in their presentation of the risks of the newer product. Instead, the public and professional medical community was directed toward the use of a defective product, he claims.

The plaintiff is seeking compensation by levying some of the following causes of action: Strict Liability, Failure to Warn, Defective Design, Negligence, Breach of Express and Implied Warranties, Gross Negligence, and Violation of Kentucky’s Consumer Protection Laws.

The DePuy Synthes Sales Lawsuit is Case No. 3:18-cv-00675-CRS in the U.S. District Court for the Western District of Kentucky, Louisville Division.