Category: Orthopedics

Lawsuits allege DePuy Orthopedics knew of ASR hip implant defects

September 1, 2010 by MassDevice staff

Less than a week after its recall of a pair of hip implants, DePuy Orthopaedics was hit with another series of lawsuits over the devices, this time alleging that the Johnson & Johnson (NYSE:JNJ) subsidiary knowingly sold defective products.

Warsaw, Ind.-based DePuy pulled its ASR hip replacement system off the market last week after receiving reports that a higher-than-normal number of patients required surgeries to correct or remove defective implants.

Orthopedic incubator Excelen inks deal with Twin Star Medical

September 1, 2010 by MedCity News

Twin Star Medical Inc. is moving to the Excelen orthopedic and bone research center in downtown Minneapolis.

The start-up, which is currently based at University Enterprise Laboratories in St. Paul, will lease a 4,000 square-foot space in the building located next to Hennepin County Medical Center beginning in November.

Orthofix secures $300 million credit line

August 31, 2010 by MassDevice staff

Orthofix International N.V. (NSDQ:OFIX) established a new credit facility worth up to $300 million.

JP Morgan Chase N.A. (NYSE:JPM) and RBS Citizens N.A. (NYSE:RBS) are the company's administrative agents for the facility, which consists of a $200 million senior secured revolving credit line and a $100 million senior secured term loan. The facility is spread across nine different financial institutions.

Exactech adds to spine line with acquisition

August 27, 2010 by MassDevice staff

Exactech Inc. (NSDQ:EXAC) bought several spinal reconstruction products from VertiFlex Inc.

The Gainsville, Fla.-based company develops biologic materials and restoration products for the hip, knee, shoulder and spine. The acquisition allows the company to expand its minimally invasive spinal surgery product offering.

DePuy Orthopedics recalls ASR hip implants

August 26, 2010 by MassDevice staff

DePuy Orthopaedics Inc. is voluntarily recalling its ASR hip replacement system after receiving reports that a higher-than-normal number of patients required surgeries to correct or remove defective implants.

The Warsaw, Ind.-based Johnson & Johnson (NYSE:JNJ) subsidiary is pulling its ASR XL Acetabular and ASR Hip Resurfacing systems from the market "due to the number of patients who required a second hip replacement procedure, called a revision surgery," according to a press release.

Stryker Biotech to pay $1.35 million to settle Bay State beef

August 26, 2010 by MassDevice staff

It took less than 24 hours for Stryker Corp. (NYSE:SYK) to settle a lawsuit filed against its Bay State-based biotech division by Mass. attorney general Martha Coakley for $1.35 million.

FDA warns Biomet on knee replacement planning system

August 17, 2010 by MassDevice staff

The Food & Drug Administration warned Biomet Inc. that its personalized knee implant planning offering, the Signature Personalized Patient Care system, lacks approval or clearance to be on the market in the U.S.

In a July 27 warning letter, the FDA warns the Warsaw, Ind.-based firm that the system, which uses MRI and CT scans to develop a pre-operative plan for implanting Biomet's Vanguard knee replacement, does not have pre-market approval, an investigational device exemption or 510(k) clearance from the watchdog agency.