Stryker Adds LFIT V40 Hip Replacement Parts to Safety Alert

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doctor holding alert sign

A new safety alert from hip implant manufacturer Stryker warns that certain sizes of its LFIT V40 femoral heads may come apart.

In the alert sent to doctors, Stryker said it “has received a higher than expected number of complaints.” Reports show the femoral head broke free of the stem that connects it to the thighbone.

This “dissociation” can cause a medical emergency. Patients will need revision surgery if their LFIT V40 femoral head fails.

Stryker identified eight sizes of LFIT V40 femoral heads that may have problems. The LFIT V40 femoral head is for total hip replacement surgery.

The FDA has not classified the alert as a recall. It can take the regulatory agency a month or two to designate a safety alert as a recall.

Stryker issued an earlier alert about the same LFIT V40 hip component two years ago. The 2018 safety alert expands on the Urgent Field Safety Notice from 2016.

The original warning included seven other sizes of the same device. The FDA classified it as a Class II recall. The 2016 Stryker recall affected more than 42,500 devices.

Injured by a Stryker hip implant? Get a Free Case Review

Stryker LFIT V40 Warning Includes More Sizes

Stryker issued the safety update on May 22, 2018. But the company manufactured the devices before March 4, 2011. It is likely most of the devices were already implanted in patients.

Stryker did not say how many devices the latest alert included. But the copy sent to Italian health regulators includes 50 pages of lot numbers.

The company also released a shortened list. It included a more general list of the latest eight sizes of devices affected.

Stryker LFIT V40 Femoral Heads Added to Product Safety Notification

Catalog Number Head Diameter Offset
6260-9-036 36mm -5
6260-9-136 36mm +0
6260-9-236 36mm +5
6260-9-336 36mm +10
6260-9-040 40mm -4
6260-9-140 40mm +0
6260-9-044 44mm -4
6260-9-144 44mm +0

What Patients Need to Know About the LFIT V40 Safety Notification

Patients with an affected part should talk with their surgeon. Stryker advised doctors to continue normal monitoring routines for patients with the devices. The company did not recommend any changes to the monitoring schedule.

Stryker told doctors and hospitals to alert any patients who received the devices. The company listed possible hip implant complications LFIT V40 patients may experience.

Possible Hip Implant Complications

  • Dislocation
  • Pain associated with implant loosening
  • Fractures to the bone around the LFIT V40
  • Revision surgery to correct problems
  • Leg length changes
  • Loss of mobility
  • Inflammatory response
  • Adverse local tissue reaction (ALTR)

Notice Could Mean More Stryker LFIT V40 Lawsuits

The announcement could add to a growing number of Stryker hip lawsuits. As of May 2018, there were 271 LFIT V40 lawsuits in a federal multidistrict litigation (MDL).

An MDL combines several similar lawsuits. It allows the lawsuits to move more quickly through the court system. At least 100 more LFIT V40 lawsuits are pending in a New Jersey state court.

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Terry Turner
Written By Terry Turner Writer

Terry Turner has been writing articles and producing news broadcasts for more than 25 years. He covers FDA policy, proton pump inhibitors, and medical devices such as hernia mesh, IVC filters, and hip and knee implants. An Emmy-winning journalist, he has reported on health and medical policy issues before Congress, the FDA and other federal agencies. Some of his qualifications include:

  • American Medical Writers Association (AMWA) and The Alliance of Professional Health Advocates member
  • Centers for Disease Control and Prevention Health Literacy certificates
  • Original works published or cited in Washington Examiner, MedPage Today and The New York Times
  • Appeared as an expert panelist on hernia mesh lawsuits on the BBC
Edited By

3 Cited Research Articles

  1. Stryker. (2018, May 22). Product Safety Notification. Ministry of Health (Italy) - Ministero della Salute. Retrieved from http://www.salute.gov.it/imgs/C_17_AvvisiSicurezza_8117_azione_itemAzione0_files_itemFiles0_fileAzione.pdf
  2. Stryker. (2016, August 29). Urgent Field Safety Notice: RA 2016-028; LFIT Anatomic CoCr V40 Femoral Heads. Retrieved from https://www.hpra.ie/docs/default-source/field-safety-notices/october-2016/v29355_fsn.pdf?sfvrsn=2
  3. U.S. Food and Drug Administration. (2016, November 9). Class 2 Device Recall Stryker LFIT Anatomic V40 Femoral Head. Retrieved from http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?ID=149782
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