SMF, STIKTITE 71352505Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 03596010619617), received between Jun 21, 2017 and Oct 9, 2019 — classified as 3 injuries.

The most frequently reported specific device problem is “Loose or Intermittent Connection” (1 report).

1 other recall cover devices cleared under the same FDA submission (K080625); 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 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryOct 9, 2019Unstable; Unstable

  IT WAS REPORTED A LEFT HIP REVISION SURGERY, PERFORMED DUE TO INSTABILITY. A FRACTURE WAS FOUND IN THE FEMUR.

  Patient problems: Injury

  MAUDE report 9171677 ↗
• InjuryNov 1, 2018Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT A REVISION SURGERY WAS REQUIRED DUE TO MECHANICAL FAILURE AND LOOSENING OF THE STEM.

  Patient problems: Injury

  MAUDE report 8028288 ↗
• InjuryJun 21, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT PATIENT UNDERWENT TWO-STEP REVISION SURGERY DUE TO LEFT TOTAL HIP ARTHROPLASTY INFECTION. FIRST STEP ON (B)(6)2016 INVOLVED THA EXPLANTATION, IRRIGATION AND DEBRIDEMENT WITH MAJOR SYNOVECTOMY AND INSERTION OF ARTICULATING ANTIBIOTIC DELIVERY DEVICE. SECOND STEP ON (B)(6)2017 INVOLVED TOTAL HIP REVISION ARTHROPLASTY.

  Patient problems: Failure of Implant; Unspecified Infection

  MAUDE report 6656148 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K080625. One submission often covers many models, so check the product and lot details in each record.

• Z-0946-2017 · Nov 15, 2016 · Terminated
  Modular Necks: 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 f