SMF, STIKTITE 71352501Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 03596010619570), received between Sep 21, 2017 and Feb 27, 2024 — classified as 8 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (4 reports).

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 16, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 27, 2024Biocompatibility; Adverse Event Without Identified Device or Use Problem; Biocompatibility; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, A PRIMARY THR SURGERY WAS PERFORMED ON (B)(6) 2012; A SMF STEM WITH STIKTITE SZ 1 WITH A RIGHT ANTEVERTED MODULAR NECK, AND R3 ACETABULAR COMPONENTS WITH AN OXINIUM HEAD WERE IMPLANTED. A REVISION WAS LATER CARRIED OUT ON (B)(6) 2022, DUE TO ELEVATED LEVELS OF CHROMIUM AND COBALT IONS WHICH WAS SAID TO HAVE CAUSED NERVOUS SYSTEM INJURY AND PAIN. DURING SURGERY, THE CUP WAS RETAINED, AND THE OTHER DEVICES WERE EXPLANTED AND REPLACED. FURTHER COMPLICATIONS HAVE NOT BEEN REPORTED.

  Patient problems: High metal ion levels; Hip Fracture; Metal Related Pathology; Nervous System Injury

  MAUDE report 18788756 ↗
• InjuryDec 9, 2021Biocompatibility; Biocompatibility

  US LEGAL - IT WAS REPORTED THAT, AFTER A LEFT THR ON (B)(6) 2016 DUE TO END-STAGE DEGENERATIVE JOINT DISEASE OF BOTH HIPS WITH VASCULAR NECROSIS. REVISION SURGERY WAS PERFORMED ON (B)(6) 2019 DUE TO A COMPLICATED POSTOPERATIVE COURSE, CHROMIUM AND COBALT LEVELS ON THE IMPLANTS REFLECTED INCREASING COBALT LEVELS IN THE 15-16 RANGE COMBINED WITH FLUID AND INCREASING/PERSISTENT PAIN. PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Metal Related Pathology; Osteolysis

  MAUDE report 12966812 ↗
• InjurySep 18, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A RIGHT HIP REVISION SURGERY OF SMF STUDY WAS PERFORMED DUE TO PAIN AND METAL IONS IN BLOOD.

  Patient problems: Injury

  MAUDE report 9083515 ↗
• InjuryMar 7, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO CONSISTENT PAIN.

  Patient problems: Pain

  MAUDE report 8399055 ↗
• InjuryDec 31, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT ON (B)(6) 2012 A PRIMARY LEFT HIP REPLACEMENT WAS PERFORMED AND IN (B)(6) 2017, PATIENT BEGAN HAVING WORSENING LEFT HIP PAIN. ON (B)(6) 2018, A REVISION SURGERY WAS PERFORMED AND ACCORDING TO SURGICAL REPORTS, BLACK FLUID WAS ENCOUNTERED IN THE JOINT AND THE STEM NEEDED TO BE REMOVED.

  Patient problems: Injury

  MAUDE report 8207187 ↗
• InjuryDec 6, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT UNDERWENT AN ASPIRATION ON THE LEFT HIP DUE TO AN INFECTION.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 8139703 ↗
• InjuryApr 23, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SHELL WAS PUT IN TOO VERTICAL. DOCTORS PLAN WAS TO REMOVE THE SHELL AND LINER BUT WHEN HE FOUND OUT THE STEM WAS A MODULAR STEM HE DECIDED TO EXPLANT EVERYTHING.

  Patient problems: Injury

  MAUDE report 7451702 ↗
• InjurySep 21, 2017Corroded; Corroded

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO CORROSION BETWEEN FEMORAL STEM AND MODULAR NECK.

  Patient problems: Injury; Pain

  MAUDE report 6883090 ↗

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