NA 71352116Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03596010619556), received between Jun 26, 2017 and Feb 21, 2020 — classified as 2 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).

2 other recalls cover devices cleared under the same FDA submission (K081124); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 21, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO LEFT HIP TRUNIONOSIS WITH METAL DEBRIS. LINER, HEAD AND STEM WERE REMOVED. THE METAL DEBRIS WERE CAUSED BY THE INTERACTION IN BETWEEN THE TITANIUM STEM AND THE CO-CR NECK.

  Patient problems: Injury

  MAUDE report 9741869 ↗
• InjuryJun 26, 2017Loose or Intermittent Connection; Device Dislodged or Dislocated; Osseointegration Problem; Loose or Intermittent Connection; Device Dislodged or Dislocated; Osseointegration Problem

  IT WAS REPORTED A REVISION SURGERY WAS REQUIRED DUE TO IMPLANT LOOSENING.

  Patient problems: Failure of Implant; Inadequate Osseointegration; Joint Dislocation; No Information

  MAUDE report 6668522 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K081124. One submission often covers many models, so check the product and lot details in each record.

• Z-0945-2017 · Nov 15, 2016 · Terminated
  Modular SMF(TM) The Modular SMF(TM) and Modular REDAPT(TM) Hip Systems are indicated for individuals undergoing primary and revision surgery where other treatments or devices have
• Z-2427-2012 · Aug 22, 2012 · Terminated
  12/14 TAPER HIGH OFFSET NECK USE WITH SMITH & NEPHEW STEMS AND 12/14 FEMORAL COMPONENTS ONLY CO-CR, REF 71352112, Smith & Nephew, Inc. Memphis, TN 38116 USA. USE WITH SMITH & NEPH