Mechanical failure of 113 uncemented modular revision femoral components

Aims

We evaluated a large database with mechanical failure of a single uncemented modular femoral component, used in revision hip arthroplasty, as the end point and compared them to a control group treated with the same implant. Patient- and implant-specific risk factors for implant failure were analyzed.

Methods

All cases of a fractured uncemented modular revision femoral component from one manufacturer until April 2017 were identified and the total number of implants sold until April 2017 was used to calculate the fracture rate. The manufacturer provided data on patient demographics, time to failure, and implant details for all notified fractured devices. Patient- and implant-specific risk factors were evaluated using a logistic regression model with multiple imputations and compared to data from a previously published reference group, where no fractures had been observed. The results of a retrieval analysis of the fractured implants, performed by the manufacturer, were available for evaluation.

Results

There were 113 recorded cases with fracture at the modular junction, resulting in a calculated fracture rate of 0.30% (113/37,600). The fracture rate of the implant without signs of improper use was 0.11% (41/37,600). In 79% (89/113) of cases with a failed implant, either a lateralized (high offset) neck segment, an extralong head, or the combination of both were used. Logistic regression analysis revealed male sex, high body mass index (BMI), straight component design, and small neck segments were significant risk factors for failure. Investigation of the implants (76/113) showed at least one sign of improper use in 72 cases.

Conclusion

Implant failure at the modular junction is associated with patient- and implant-specific risk factors as well as technical errors during implantation. Whenever possible, the use of short and lateralized neck segments should be avoided with this revision system. Implantation instructions and contraindications need to be adhered to and respected.