Zimmer Hip Implant has been in the news for its unsafe and defective nature since last few years. However, this time the manufacturer is being slammed by the U.S.F.D.A for not complying with regulatory norms and requirements.

In a letter issued by the agency on September 19th, the FDA warned Zimmer that it “failed to implement a testing mechanism to demonstrate the products met certain design specifications and had not validated the effects of manufacturing operations on products that incorporate metallic spikes.” 

The warning was issued following an inspection of the manufacturing plant based at Ponce. However, the company has said that FDA’s move is not going to have any impact on their hip-implant production and marketing goals and for the sake of consumer safety the company has decided to halt releasing defective implants for the time being.

After a sudden inspection at one of the production units at Puerto Rico the agency notified in a letter to the manufacturer on September 19 2012 that Zimmer was not complying with federal regulations in place for the production of its Trilogy Acetabular Systems which is a matter of great concern for consumers as well the agency.

Detailing the incidence the FDA, pointed out that the manufacturing unit is violating the regulatory norms particularly in two areas that are of utmost importance which includes a) validating the effects of manufacturing operations on implant that incorporates metallic spikes and b) testing to uphold design specification.

Meanwhile, the manufacturer says that FDA has not issued any notification to the manufacturer to stop the production or to ban the shipment of the device across theUnited States. However, to minimize associated risks the company has temporarily and voluntarily halted the release of the implants and the decision is completely its own.

It is important to underline here that Zimmer hip implants are used in hip replacement surgeries to give patients relief from problems related to hip and hip-bone. The device is designed to facilitate implantation through a smaller incision so that muscles and tendons around the hip are not damaged.

Zimmer Holdings is the world’s largest producer of orthopedic devices.  The company manufactures various components and products for implant and is recommended as per the requirements and problems of the patient. Some of them are as follows.

  • Zimmer M/L Taper Hip Prosthesis
  • The Fitmore Hip Stem
  • Continuum Acetabular system
  • Metasul Metal-on-Metal articulation

However, the implant has been receiving huge criticism over its complications and hazardous impact on consumers. Some of the complications associated with the device are:

  • Pain at the implant
  • High Failure rate
  • Necrosis (tissue death)
  • Increased levels of cobalt and chromium ions
  • Bone loss or Osteolysis
  • Formation of solid mass and Fluid collection around the hip joint

The Zimmer Hip Implant was approved by FDA in 2006 and since then it has been gaining huge attention of public as well as regulatory authorities. However, the company has assured that it will assist the authority at most to ensure the safety of people and will continue working to offer best services to the people.