PROFEMUR Neck Varus/Valgus CoCr 8 Degree, Part number PHAC 1254 by MicroPort Orthopedics: Class I Recall - Unexpected Rate of Fractures After Surgery

[Posted 10/02/2015]

AUDIENCE: Risk Manager, Orthopedics

ISSUE: MicroPort Orthopedics Inc. has received reports of an unexpected rate of fractures after surgery related to this specific modular neck. If the modular neck fractures, the patient may experience sudden pain, instability and difficulty walking and performing common task. An acute fracture will require revision surgery to remove and replace the neck and stem components. Acute fracture and emergency revision surgery is a serious adverse health consequence and could lead to neurovascular damage, hematoma, hemorrhage, and even death.

BACKGROUND: During total hip replacement surgery, the damaged portions of the hip joint are removed and replaced with prosthetic parts including a femoral head, femoral stem and modular neck. The PROFEMUR Neck Varus/Valgus CoCR, part number PHAC1254 is the modular neck being recalled.

RECOMMENDATION: On August 7, 2015, MicroPort Orthopedics Inc. informed distributors and hospital staff of a voluntary device product recall. Distributors and hospital staff, including risk managers and surgeons, were instructed to stop using and distributing the affected product, and return the recalled product to MicroPort Orthopedics Inc. Distribution Center at 11481 Gulf Stream, Arlington, TN 38002. See the Recall Notice for additional information for health professionals and patients.

Questions should be directed to MicroPort Orthopedics Inc.’s Customer Experience Department at 1-866-872-0211, Monday through Friday, between the hours of 7:30 a.m. and 7:30 p.m. Central Standard Time.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.fda.gov/MedWatch/report
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

[10/02/2015 - Recall Notice - FDA]