FL Woman Claims Durom Hip Replacement Failure Caused Agony
On January 24, 2014, Mary Lipstate of Naples, Florida filed a Zimmer Durom Cup hip lawsuit against Zimmer, Inc. , the manufacturer of the Durom Cup device, in U.S. District Court, Middle District of Florida (Ft. Myers).
The suit has been consolidated along with other similar suits into federal multidistrict litigation (MDL) in the U.S. District Court for the District of New Jersey. The plaintiff claims that Zimmer designed, manufactured, and sold a defective product while neglecting to provide adequate warnings concerning the risk of failure, pain, and immobility.
Ms. Lipstate alleged that the Durom Cup hip replacement she received in implantation surgery in June of 2007 failed to bond with her hip bone. This resulted in the Durom Cup detaching from the hip bone and damaging her pelvic bone. The failure has caused her devastating pain and agony and a restriction of the physical activities she had previously enjoyed.
Zimmer hip complications surface almost immediately
Approved by the FDA’s expedited 501 (K) clearance process in 2006, which requires no dedicated human testing, the Durom Cup implant is a metal on metal device– a metal ball inside a metal socket. The outside of the device is sprayed with titanium plasma intended to facilitate the adhesion of the device to the hip bone. An implantation is considered successful when the patient’s own bone fuses into the exterior shell of the cup which would then hold it in place. However, soon after approval, orthopedists began to see problems with the Durom Cup’s failure to adhere to the bone.
In 2007, Dr. Lawrence Dorr, a respected surgeon and researcher and a former Zimmer consultant, informed Zimmer that the device was failing more frequently than expected. Zimmer ignored his warning, and in April 2008, Dr. Dorr wrote a public letter to his surgical colleagues informing them that he did not believe the fixation surface of device to bone was working and that he had stopped using the Durom Cup. In response to the Dorr letter and to the growing number of Durom Cup complaints, Zimmer temporarily suspended sales in July 2008 for “reassessment.”
However, after a month, Zimmer declared that Dr. Dorr and other surgeons were to blame for the failures and returned the Durom Cup to the market instituting a new set of surgical instructions. The Durom Cup continues to be sold despite the cloud of Zimmer hip complications.
Many Durom Cup hip lawsuits resulting in settlements
Complaints about Zimmer hip complications have continued to mount including the possibility that metal flakes from the implant could enter the patient’s bloodstream and cause metal poisoning. In 2011, the FDA fielded over 5,000 complaints related to metal on metal implants like the Durom Cup. A study published in Lancet in 2012 concluded that metal on metal implants have early failure rates two to four times higher than other device materials.
Many of the plaintiffs in the New Jersey MDL have agreed to meet with reps from Zimmer, Inc. which has settled a large number of lawsuits.
The defendant has already indicated that its total Zimmer Durom Cup hip lawsuit settlement costs may well rise to over $600 million as more plaintiffs continue to join the MDL.
- FDA, Medical Device Recalls http://www.fda.gov/medicaldevices/productsandmedicalprocedures/implantsandprosthetics/metalonmetalhipimplants/ucm241770.htm
- JOURNAL GAZETTE, Zimmer’s Hip Takes a Hit http://www.journalgazette.net/article/20090608/biz/306089936