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.
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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.
