Smith & Nephew, Inc.JDIClass II

Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented

Smith & Nephew, Inc.'s record for this product code

MDR events2,291All time

Recalls3All time

510(k) clearances10All time

Recent MDR events

2,291 adverse event reports on file

Recalls

3 recall events for this product code

TerminatedMay 9, 2018
Three lots of Anthology HO Porous size 7 stems were manufactured with an undersized taper length. The device taper length was incorrectly manufactured as 0.393mm opposed to 0.442 mm.
View FDA record ↗
TerminatedNov 20, 2009
Radius at the end of the taper of the femoral implant is smaller than specification. This error could result in the tapers not locking fully or properly on femoral stems or in causing impingement and/or increased wear debris. The deficiency may not be noticed by the user. Impingement and/or wear debris may lead to revision.
View FDA record ↗
TerminatedUnknown
The firm received complaints of cracks in the weld on the head of the mallet. In the reported cases, some of the lead beads and particles escaped from the mallet into the surgical wound.
View FDA record ↗

510(k) clearances

10 clearances for this product code