Device product
smith&nephew POLARSTEM(TM) Femoral Stems with Ti/HA (Standard, Lateral, Valgus and Collar), REF 76102260, NON STERILE, QTY: (1), Rx only The subject cardan is used in conjunction with a curved stem impactor used to implant the POLARSTEM hip stem. The hip stem is mounted on the screw at the tip of the instrument, and the stem is then impacted into the femur. After impaction, the surgeon uses a knob at the end of the cardan to unscrew the implanted stem from the instrument
Z-3100-2017
Product summary
- Event
- Event 77827
- Status
- Terminated
- Classification
- Class II
- Quantity
- 402 units
- Official record key
device-enforcement:Z-3100-2017
Official wording
Reason: The Cardan joint of the Polarstem Cardan could potentially fracture or functionally fail after multiple procedures.
Code information: Lot Numbers: A57835, A57837, A58509, A59084, A59446, A59547, A60948
Distribution pattern: Worldwide Distribution - US (Nationwide) and Internationally to Australia, Belgium, Norway, and Switzerland.
Derived failure modes
-
Unknown
The Cardan joint of the Polarstem Cardan could potentially fracture or functionally fail after multiple procedures.