A Pennsylvania man’s Zimmer hip lawsuit alleges he suffered substantial injury and distress when his hip implant failed and had to be replaced.

According to this Zimmer hip lawsuit, Plaintiff Charles R. had his right hip joint replaced with a prosthetic unit on Dec. 4, 2008. The prosthetic used in the procedure was the Metasul Durom hip system, which according to Charles included the Durom acetabular cup, femoral head, femoral head adapter, and medium to large taper femoral stem.

Close to nine years later in early April 2017, Charles says the Metasul Durom hip system failed, and he was forced to undergo a complete revision of the original total hip arthroplasty (THA).

Charles claims this need created additional physical and emotional trauma for the patient and exposed him to severe medical risks including blood loss, clots, bone loss, and the chance that future prosthetics would fail early because of his compromised anatomy. Additionally, Charles says he incurred grave medical expenses for which he is ultimately liable.

Charles R. registered his legal complaint under Multidistrict Litigation (MDL) No. 2158 in the District of New Jersey. This and other Zimmer hip lawsuit product liability claims have been consolidated in this district for efficient adjudication.

The History of the Metasul Durom Hip System and Associated Problems

As indicated by the U.S. Food and Drug Administration (FDA) and this Zimmer hip lawsuit, the FDA cleared the Metasul Durom hip system for commercial release in 2003 through its 510(k) clearance process—which references Section 510(k) of the Medical Device Amendments (MDA) of 1976 of the Federal Food, Drug, and Cosmetic Act.

The main rule of this controversial process is that the manufacturer must show the device they desire to market is “substantially equivalent” to a pre-1976 FDA approved device that is already on the market. The drug and device oversight agency must be notified 90 days ahead of the intend to market. The process requires no clinical safety trials and doesn’t come with any FDA statement of safety.

The defendant allegedly claimed that the Durom Cup system was equivalent to three metal-on-metal devices which were cleared by the FDA in the 1970s but later dropped by the industry as a whole due to a high failure rate.

The Durom Cup system had a monoblock design which increased the surface area the metal femoral head could rotate within. This purportedly allowed for greater range of motion and less of a tendency for the hip to dislocate than earlier MOM hip prosthetics, because the acetabular cup had no liner. It also increased the surface area of contact between the femoral head and the acetabular cup.

According to the FDA and this lawsuit, the defendant initiated a recall of the Durom Cup system which was in place for little over one year from late September 2008 to late October 2009.

The high failure rate of the device was blamed upon orthopedic surgeons and inadequate techniques of implantation. The recall affected 19,014 units. The Durom Cup system was put back on the market after Zimmer offered training to surgeons, rather than responding to the statistics regarding loosening and failure of the device.

In this case, complainant Charles alleges that the defendant was negligent and remiss in not warning the public regarding obvious risks associated with the device. Metal-on-metal shredding has been associated with hip prosthetic failure, neurological problems, bone loss, some cancers, and even heart disease.

The Zimmer Lawsuit is Case No. 2:19-cv-08368-SDW-SCM in the U.S. District Court for the District of New Jersey.