BfArM has received several incident reports about fractures in the neck area of the stem hip implant made of titan alloy. The failures occurred some time after a revision of the bearing components was previously necessary.

Discolored regions of the surface were found on the retrieved stems, notably coincident with the fracture initiation region. This suggests damage due to contact with cautery during previous surgery. Such damages have been already reported in scientific publications. ^{(1, 2, 3)}

BfArM would like to draw your attention to the above mentioned problem, especially to the recommendation made in these scientific publications to avoid contact between high frequency instruments and in situ metal components.

(1) Orthopäde 2009;38(7):622-625.
(2) Orthopäde 2014;43(12):1106-1111.
(3) J Bone Joint Surg Am. 2019;101(10):868-878.

In case of questions please contact:

Federal Institute for Drugs and Medical Devices
Medical Devices Division
Kurt-Georg-Kiesinger-Allee 3
53175 Bonn

Telephone: +49 (0)228 99 307-3202 (Non-active medical devices)
Facsimile: +49 (0)228 99 307-5300
E-Mail: md-vigilance@bfarm.de