Retrieval Findings of Recalled Dual-Taper Hips

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Abstract

Background:

The recent high-profile recalls of several dual-taper hip designs pose questions regarding why those designs perform poorly. We aimed to characterize taper damage in 1 recalled design to understand failure mechanisms to inform surgeons on which patients should be considered at risk of revision and when to revise.

Methods:

High-precision measurement equipment was used to characterize the metal loss from the neck-stem interface of 116 retrieved Rejuvenate femoral stems (Stryker Howmedica Osteonics) revised because of an adverse reaction to metal debris. Head-neck taper surfaces were also investigated, and clinical and laboratory data were examined.

Results:

The neck-stem junction of each implant was moderately to severely corroded and showed a characteristic wear pattern on both male and female taper surfaces. The severity of taper damage was positively correlated with time to revision (coefficient, 0.040 [95% confidence interval (CI), 0.028 to 0.051]; p < 0.0001) and with serum cobalt concentration (coefficient, 0.02 [95% CI, 0.01 to 0.02]; p < 0.0001) and serum chromium concentration (coefficient, 0.04 [95% CI, 0.009 to 0.070]; p = 0.0142).

Conclusions:

A forensic examination of the retrieved components that failed secondary to an adverse reaction to metal debris showed, in all cases, visible corrosion. Of the implant and patient factors investigated, we did not identify any predictors of corrosion. The severity of damage was found to increase with time; cobalt was significantly elevated over chromium.

Clinical Relevance:

Surgeons should scrupulously follow and consider revision for patients with this implant design to avoid extensive tissue excision. Blood metal ion tests may aid in identifying the mechanisms of taper corrosion.

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