SMF, STIKTITE 71352504Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 03596010619600), received between Sep 27, 2018 and Dec 7, 2021 — classified as 3 injuries.

The most frequently reported specific device problem is “Biocompatibility” (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.

• InjuryDec 7, 2021Biocompatibility; Biocompatibility

  *US LEGAL * IT WAS REPORTED THAT, AFTER A LEFT THR ON (B)(6) 2012 DUE TO OSTEOARTHRITIS, PLAINTIFF HAS EXPERIENCED AN IMPLANT MECHANICAL FAILURE, SIGNIFICANT ELEVATED COBALT CHROMIUM LEVELS AND AN MRI SHOWED AN ABDUCTOR MUSCLE TENDON TEAR. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2021 WHERE IT WAS FOUND A PSEUDOTUMOR ENGULFING THE ABDUCTOR MUSCLE, AFTER A DEBRIDED THERE WAS A LARGE DISRUPTION OF THE ENTIRE MUSCLE AND IT WAS NOTICED THE FEMORAL COMPONENT DOWN TO THE ACETABULAR COMPONENT AND CORROSION AT THE MODULAR NECK TO STEM INTERFACE. THE R3 3 HOLE ACET SHELL 56MM REMAINED AND WAS NOT EXPLANTED. PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Laceration(s); Metal Related Pathology

  MAUDE report 12952809 ↗
• InjurySep 12, 2019Appropriate Device Problem Term/Code Not Available; Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT AFTER A RIGHT THA HAD BEEN PERFORMED ON (B)(6) 2013 WITH AN R3/SMF SYSTEM DUE TO COXARTHROSIS, THE PATIENT EXPERIENCED PERIPROSTHETIC PAIN AND METALLOSIS. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2018 TO ADDRESS THIS ADVERSE EVENT. CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Test Result

  MAUDE report 9005699 ↗
• InjurySep 27, 2018Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATIENT WAS COMPLAINING OF PAIN. A REVISION SURGERY WAS PERFORMED DUE TO INFECTION.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 7915434 ↗

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