SMF, STIKTITE 71352503Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 03596010619594), received between May 22, 2018 and Feb 27, 2023 — classified as 6 injuries.

The most frequently reported specific device problem is “Biocompatibility” (2 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 18, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 27, 2023Biocompatibility; Adverse Event Without Identified Device or Use Problem; Biocompatibility; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A RIGHT TOTAL HIP ARTHROPLASTY PERFORMED ON (B)(6) 2013, THE PLAINTIFF EXPERIENCED PAIN. THEREFORE THE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2022, IN WHICH EVIDENCE OF SOFT TISSUE REACTION AROUND THE HIP IMPLANT WAS OBSERVED, AND ONCE THE MODULAR NECK WAS DIS-IMPACTED, THERE WAS EVIDENCE OF METAL DEBRIS ON THE TAPER JUNCTION. THERE WAS OSTEOLYSIS AROUND THE PROXIMAL FEMUR (PAPROSKI IIIA) AND THE ACETABULUM (PAPROSKI IIB). INTRAOPERATIVELY, A CALCAR CRACK WAS ALSO NOTICED. ALL COMPONENTS WERE EXPLANTED AND REPLACED WITH A THR SYSTEM FROM A COMPETITOR. THE PATIENT HAD GOOD RECOVERY, HOWEVER, ABOUT A MONTH AFTER THE REVISION SURGERY, HE SUSTAINED AN ACUTE GREATER TROCHANTER FRACTURE; WHICH WAS TREATED WITHOUT SURGICAL INTERVENTION AND APPEARS TO HAVE HEALED. HE ALSO SUSTAINED A POST REVISION DISLOCATION, TREATED WITH A CLOSED REDUCTION.

  Patient problems: Bone Fracture(s); Metal Related Pathology; Osteolysis; Pain; Unspecified Tissue Injury

  MAUDE report 16448358 ↗
• InjurySep 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TOTAL HIP REPLACEMENT CONSTRUCT HAD BEEN IMPLANTED ON THE PATIENT¿S RIGHT HIP ON (B)(6) 2013, THE PATIENT EXPERIENCED PAIN, METALLOSIS AND ELEVATED COBALT LEVELS. A REVISION SURGERY WAS CONDUCTED ON (B)(6) 2022 TO TREAT THIS ADVERSE EVENT. DURING THIS PROCEDURE, THE FEMORAL HEAD, ACETABULAR LINER, MODULAR NECK, AND THE FEMORAL PROSTHESIS WERE REMOVED AND REPLACED WITH A COMPETITOR¿S SYSTEM. INTRAOPERATIVELY, A BLACKENED DISCOLORATION DEEP IN THE FEMORAL END OF THE TRUNNION TAPER JUNCTION WAS NOTICED WHEN THE FEMORAL NECK WAS REMOVED FROM THE STEM. AN EXTENDED TROCHANTERIC OSTEOTOMY WAS NECESSARY TO REMOVE THE FEMORAL COMPONENT, DURING WHICH A GREATER TROCHANTER FRACTURE OCCURRED. THERE WAS A MODERATE BONE LOSS OF THE PROXIMAL METAPHYSIS OF THE FEMUR AS A RESULT OF STEM REMOVAL GIVEN ITS COMPLEXITY, AS THE IMPLANT WAS FOUND TO BE COMPLETELY INGROWN DISTALLY. THE PATIENT WAS AWOKEN FROM ANESTHESIA AND TRANSFERRED TO THE RECOVERY BED AND TAKEN TO THE RECOVERY ROOM IN STABLE CONDITION. PATIENT HAS BEEN RECOVERING WELL FROM THE PROCEDURE, HIS COBALT LEVELS HAVE DROPPED TO 1.1 AND IS ABLE TO AMBULATE WITHOUT A CANE OR WALKER.

  Patient problems: Bone Fracture(s); Hip Fracture; Metal Related Pathology

  MAUDE report 15407847 ↗
• InjuryMay 31, 2021Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT, AFTER A LEFT THR PERFORMED ON (B)(6) 2014, THE PLAINTIFF EXPERIENCED HIGH FEVER AND ABNORMAL METAL ION LEVELS IN BLOOD. A TWO-STAGE REVISION SURGERY WAS PERFORMED TO TREAT THESE ADVERSE EVENTS; ON (B)(6) 2020 THE DEVICES WERE EXPLANTED, AND A CEMENT SPACER WAS APPLIED, LEAVING THE PLAINTIFF WITH NO MOBILITY. THEN ON (B)(6) 2020 THE REVISION SURGERY WAS COMPLETED WITH THE IMPLANTATION OF NEW PROSTHESIS. THE PATIENT WALKS WITH THE AID OF A FOREARM CRUTCH AND SUFFERS FROM INSTABILITY, PAIN, AND EXTREME WEAKNESS IN HIS LOWER LEFT LIMB AND DIFFICULTY IN BENDING.

  Patient problems: Ambulation or Postural Difficulties; Fever; High metal ion levels; Loss of Range of Motion; Metal Related Pathology

  MAUDE report 11907564 ↗
• InjuryDec 18, 2020Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  IT WAS REPORTED THAT, AFTER A MINI HIP STEM PROCEDURE, THE DEVICE WAS REMOVED DUE TO PAIN LEADING TO REVISION SURGERY. NO OTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Failure of Implant

  MAUDE report 11041937 ↗
• InjuryJan 27, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY DUE TO BONE DAMAGE, BONE LOSS AND OSTEOLYSIS IN THE HIP. THE REVISION INCLUDED A FULL EXTENDED TROCHANTERIC OSTEOTOMY AND HEAD/LINER SWAP.

  Patient problems: Injury; Osteolysis

  MAUDE report 9633815 ↗
• InjuryMay 22, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT HAD A DISLOCATION OF THE RIGHT HIP JOINT. THE PATIENT WAS TREATED IN HOSPITAL FROM THE (B)(6) 2011 TO THE (B)(6) 2011. MULTIPLE CLOSED REDUCTIONS WERE DONE. EVENTS WERE CLASSIFIED BY AEMB AS SADES AND DEEMED TO REPRESENT A SINGLE COMPLAINT CONSIDERING THEY ALL RELATE TO SAME TOTAL HIP.

  Patient problems: Joint Dislocation

  MAUDE report 7534022 ↗

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