Stryker issued a safety alert May 22 warning its LFIT V40 femoral heads used for total hip replacement surgery may come apart, Drug Watch reports.
Here are seven insights:
1. The LFIT V40 femoral head has broken off the stem connecting it to the thighbone, which can cause patients to require revision surgery.
2. Eight sizes of LFIT V40 femoral heads may be affected. Stryker did not say how many devices — which were manufactured before March 4, 2011 — are included in the alert.
3. The safety alert expands on Stryker's 2016 warning about the same device, which included seven other sizes. The FDA classified that alert as a Class II recall, affecting more than 42,500 devices.
4. The company instructed physicians and hospitals to alert any patients who received the devices but continue monitoring patients with devices as normal.
5. LFIT V40 patients may experience complications including dislocation, pain from implant loosening, bone fractures, leg length changes and loss of mobility.
6. As of May, Stryker faced 271 LFIT V40 lawsuits in a federal multidistrict litigation. At least 100 more lawsuits concerning the device are pending in New Jersey.
7. Here are the catalog numbers for the eight device sizes affected:
6260-9-036
Head diameter: 36mm
Offset: -5
6260-9-136
Head diameter: 36mm
Offset:+0
6260-9-236
Head diameter: 36mm
Offset:+5
6260-9-336
Head diameter: 36mm
Offset:+10
6260-9-040
Head diameter: 40mm
Offset:-4
6260-9-140
Head diameter: 40mm
Offset:+0
6260-9-044
Head diameter: 44mm
Offset:-4
6260-9-144
Head diameter: 44mm
+0