Stryker Adds LFIT V40 Hip Replacement Parts to Safety Alert | 合法醫療器材資訊網

2018年6月6日—PatientswillneedrevisionsurgeryiftheirLFITV40femoralheadfails.StrykeridentifiedeightsizesofLFITV40femoralheadsthatmayhave ...

A new safety alert from hip implant manufacturer Stryker[1] 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[2] 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...