Smith & Nephew’s hip test charge
REPLACEMENT joint maker Smith & Nephew is facing concerns about one of its hip devices after US regulators criticised manufacturing procedures at a German plant.
The US Food & Drug Administration (FDA) told the group it was dissatisfied with production procedures used to make the R3 Ceramic Acetabular system at its site in Tuttlingen in Germany. S&N shares fell 9p to 677p.
The FDA said in a letter on December 21 that S&N had not performed certain required tests and had failed to establish and maintain procedures to correct problems, identified in July, in making the systems.
S&N said it had not yet seen the letter, but it had taken remedial action to solve issues raised by the FDA in July and could continue to meet demand for the device from production at its UK plant in Warwick and Memphis in the US.
A company spokesman said: “The FDA raised the issue in July and Smith & Nephew has put in place remedial action. Presumably the FDA is not happy with that remedial action, but we do not know what the issue is.” He said there were no reports of incidents involving patients.
