SMF, STIKTITE 71352502Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 03596010619587), received between Jun 6, 2017 and Oct 17, 2023 — classified as 17 injuries.

The most frequently reported specific device problem is “Biocompatibility” (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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• InjuryOct 17, 2023Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT, AFTER A THA SURGERY OF THE RIGHT HIP PERFORMED ON (B)(6) 2015, THE PATIENT EXPERIENCED A FAILED THA. THIS CONDITION WAS TREATED BY A PERFORMING A REVISION SURGERY OF THE RIGHT HIP ON (B)(6) 2023, DURING WHICH THE STEM, THE MODULAR NECK, THE FEMORAL HEAD AND THE LINER WERE EXPLANTED AND REPLACED WITH A SMITH AND NEPHEW LINER AND A BIOLOX DELTA FEMORAL HEAD WITH AN ARCOS 150MM STS STEM. DURING THE SURGERY, THERE WAS CLEAR METALLOSIS/TENDINOSIS TYPE WEAR AT THE MODULAR JUNCTION WHERE THE MODULAR NECK MEETS THE STEM. THROUGHOUT THE CASE THERE WAS PSEUDOTUMOR AND FLUID THAT WAS DEBRIDED, INCLUDING THE MEDIAL TISSUES DISTAL TO THE LESSER TROCHANTER. AFTER THE SURGERY, THE PATIENT WAS TRANSFERRED TO THE RECOVERY ROOM IN A STABLE CONDITION, HE WILL BE TOE-TOUCH WEIGHT-BEARING. NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: Metal Related Pathology

  MAUDE report 17950793 ↗
• InjuryMar 28, 2022Biocompatibility; Biocompatibility

  US LEGAL MDL: IT WAS REPORTED THAT, AFTER TOTAL RIGHT HIP REVISION WAS PERFORMED ON (B)(6) 2017 DUE TO AN INFECTION (REPORTED UNDER (B)(4)), THE PATIENT HAD AN ASPIRATION UNDER GENERAL ANESTHESIA AND APPROXIMATELY 7 CC OF A SOMEWHAT CLOUDY JOINT FLUID WAS REMOVED FROM THE RIGHT HIP (REPORTED UNDER (B)(4)). SUBSEQUENTLY, TEST RESULTS FROM 2021 INDICATED ELEVATED COBALT AND CHROMIUM LEVELS IN BLOOD (CHROMIUM: 3.5 MCG/L AND COBALT: 7.2 MCG/L). IT WAS NOT REPORTED IF OR HOW THIS ADVERSE EVENT WAS TREATED. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Metal Related Pathology; Pain

  MAUDE report 13927420 ↗
• InjuryJun 16, 2021Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT, AFTER A RIGHT HIP THR CONSTRUCT HAD BEEN IMPLANTED ON (B)(6) 2012 PELVIS SWELLING, DECREASED RANGE OF MOTION AND A GREAT TROCHANTERIC FRACTURE. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2020 TO TREAT THIS ADVERSE EVENT; THE STEM, NECK, FEMORAL HEAD AND INSERT WERE EXPLANTED. THE TROCHANTERIC FRACTURE WAS INTERNALLY FIXED USING #5 TICRON TAG SUTURES THROUGH A BONY BRIDGE. UPON REVISION, THE SURGEON NOTICED A CLOUDY FLUID IN THE JOINT CONSISTENT WITH METALLOSIS. AFTER REVISION SURGERY, THE PLAINTIFF ATTENDED PHYSICAL THERAPY TO IMPROVE STRENGTH, ENDURANCE AND BALANCE IN HER RIGHT LEG.

  Patient problems: Bone Fracture(s); Loss of Range of Motion; Metal Related Pathology; Pain; Swelling/ Edema

  MAUDE report 12011030 ↗
• InjuryMay 31, 2021Biocompatibility; Biocompatibility

  *EU LEGAL* IT WAS REPORTED THAT, AFTER A THR PERFORMED ON (B)(6) 2014, THE PLAINTIFF EXPERIENCED HIGH FEVER AND HIGH LEVELS OF COCR 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 OUTCOME IS UNKNOWN.

  Patient problems: Fever; Loss of Range of Motion; Metal Related Pathology

  MAUDE report 11907574 ↗
• InjuryApr 28, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A PRIMARY RIGHT THR, THE PATIENT PRESENTED PAIN IN THE JOINT, PSEUDOTUMOR FORMATION AND MECHANICAL LOOSENING OF THE JOINT PROSTHESIS. A REVISION SURGERY WAS PERFORMED TO EXPLANT A SMF STEM WITH STIKTITE SZ 2, OXINIUM FEMORAL HEAD 12/14 32MM -3 AND A R3 20 DEGREE XLPE ACETABULAR LINER 32MM INNER DIAMETER X OUTER DIAMETER. THE OUTCOME OF THE PATIENT IS UNKNOWN.

  Patient problems: Ambulation or Postural Difficulties; Failure of Implant; Joint Laxity; Laceration(s); Metal Related Pathology; Osteolysis; Pain; Unequal Limb Length

  MAUDE report 11736181 ↗
• InjuryAug 10, 2020Corroded; Corroded

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED IN THE RIGHT HIP DUE TO RECURRENT INSTABILITY, SECONDARY TO RIGHT HIP WITH ALTR AS A CONSEQUENCE OF TRUNNIONOSIS OF THE FEMORAL COMPONENT. LINER, CUP, STEM AND FEMORAL HEAD WERE REMOVED.

  Patient problems: Erosion; Failure of Implant; Injury; Metal Related Pathology

  MAUDE report 10383434 ↗
• InjuryJul 9, 2020Corroded; Adverse Event Without Identified Device or Use Problem; Corroded; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SMF STEM WAS REVISED DUE TO CORROSION AT NECK JUNCTION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Failure of Implant; Insufficient Information; No Known Impact Or Consequence To Patient

  MAUDE report 10254383 ↗
• InjuryJun 16, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD A DEEP POST OPERATIVE INFECTION (ECOLI) AND A REVISION SURGERY WAS PERFORMED TO REMOVE ALL COMPONENTS.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 10160690 ↗
• InjuryDec 4, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT MRI DEMONSTRATED MILD DEFUSE FATTY INFILTRATION. RIGHT HIP ASPIRATION WAS PERFORMED.

  Patient problems: Aspiration/Inhalation

  MAUDE report 9409375 ↗
• InjuryJan 5, 2019Corroded; Corroded

  IT WAS REPORTED THAT A REVISION SURGERY OF A TOTAL HIP ARTHROPLASTY WAS PERFORMED DUE TO METAL ON METAL DUAL TAPER CORROSION WITH ADVERSE TISSUE REACTIONS WITH EXTENSIVE ABDUCTOR NECROSIS AND PROXIMAL FEMORAL OSTEOLYSIS. DURING SURGERY THE SURGEON FOUND ROUGHLY 200CC OF METALLIC STAINED FLUID UNDER TENSION, THERE WAS SIGNIFICANT NECROSIS WITHIN THE JOINT AND MORE THAN 50% OF THE ABDUCTORS WERE NECROTIC, A SIGNIFICANT AMOUNT OF NECROTIC SOFT TISSUE WAS REMOVED. THE IMPLANTS REMOVED WERE THE STEM, FEMORAL HEAD AND MODULAR NECK, WHICH HAD SIGNIFICANT CORROSION IN IT. THE MONTHS PRIOR TO THE REVISION SURGERY, THE PATIENT WAS COMPLAINED OF PAIN AND WHEN TO THE HOSPITAL ON (B)(6), FOR AN ORTHOPEDIC EVALUATION, DIAGNOSED X-RAYS WERE OBTAINED AS WELL AS A CT SCAN OF THE PELVIS AND THE HIP, AFTER EVALUATION THE PATIENT WAS REFERRED TO SSH FOR A FLUOROSCOPIC GUIDED ARTHROCENTESIS OF THE RIGHT HIP. ALSO, LABS ANALYSIS WERE TAKEN AND THE PATIENT WAS FOUND TO HAVE A COBALT METAL ION LEVEL OF 9.5, CHROMIUM LEVEL OF 1.4, C-REACTIVE PROTEIN LEVEL OF 13.6, AND SEDIMENTATION RATE OF 57. ON (B)(6), AN MRI REVEALED A 6X2X3.3CM FLUID COLLECTION ABOUT THE GREATER TROCHANTER AND ATROPHY OF GLUTEUS. ON (B

  Patient problems: Injury; Tissue Damage

  MAUDE report 8220594 ↗
• InjuryDec 31, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO METALLOSIS . THE STEM , THE MODULAR NECK AND THE FEMORAL HEAD WERE REMOVED.

  Patient problems: Injury

  MAUDE report 8207158 ↗
• InjuryDec 31, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT ON (B)(6) 2017 PATIENT HAD A COMPUTED TOMOGRAPHY THAT SHOWED EFFUSION OF THE RIGHT HIP AND STRONGLY SUGGEST METALLOSIS AND ON (B)(6) 2017 AND MRI WAS PERFORMED AND SHOWED ABNORMAL SOFT TISSUE SIGNAL COMPATIBLE WITH PSEUDOTUMOR ALONG WITH MODERATE ATROPHY OF THE GLUTEUS MEDIUS AND MILD ATROPHY OF THE GLUTEUS MAXIMUS.

  Patient problems: Injury

  MAUDE report 8206125 ↗
• InjurySep 13, 2018Break; Break

  IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED. MECHANICAL FALL SECONDARY TO ETOH (ALCOHOL), FELL ON RIGHT SIDE, CAUSING PERIPROSTHETIC FRACTURE. SUBJECT HAD FEMORAL STEM, FEMORAL HEAD AND FEMORAL NECK REVISED.

  Patient problems: No Information

  MAUDE report 7875130 ↗
• InjuryJun 7, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING A REVISION SURGERY, THE PATIENT SUFFERED FROM A TROCHANTERIC FRACTURE. A NEW DEVICE WAS IMPLANTED, AS WELL AS, A PLATE, CABLES, AND SCREWS TO ADDRESS THE TROCHANTERIC FRACTURE.

  Patient problems: Injury

  MAUDE report 7576903 ↗
• InjuryJun 6, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT AN MRI OF THE PATIENT RIGHT HIP REVEALED CONSISTENT FINDINGS WITH PSEUDOTUMOR ASSOCIATED WITH THE RIGHT HIP ARTHROPLASTY WITH LARGE COMPLEX SOFT TISSUE FLUID. REVISION SURGERY WAS RECOMMENDED. ON (B)(6) 2018, HE UNDERWENT REMOVAL OF HIS DEVICES. OUT OF CONCERN THAT THE CLOUDY FLUID ENCOUNTERED INTRAOPERATIVE WAS SUSPICIOUS FOR INFECTION, ALL OF HIS COMPONENTS WERE REMOVED AND A TEMPORARY SPACER WAS IMPLANTED.

  Patient problems: Injury

  MAUDE report 7576236 ↗
• InjuryNov 3, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT A TWO-STEP REVISION SURGERY DUE TO DIAGNOSIS OF LEFT TOTAL HIP ARTHROPLASTY PERIPROSTHETIC INFECTION. FIRST STAGE COMPRISED OF REMOVAL OF ALL COMPONENTS AND PLACEMENT OF ANTIBIOTIC SPACER AND ANTIBIOTIC BEDS, IRRIGATION AND DEBRIDEMENT. SECOND COMPRISED OF AB SPACER REMOVAL AND REIMPLANTATION OF LEFT HIP ON (B)(6) 2017. PREOPERATIVE DIAGNOSIS WAS LEFT HIP ARTHROPLASTY FAILURE WITH CORROSION AT THE STEM NECK JUNCTION AS PATIENT WAS EXPERIENCING PAIN AND HAD SOMEWHAT ELEVATED LAB RESULTS. INFECTION WAS DETECTED INTRAOPERATIVELY AND DIAGNOSIS WAS CHANGED.

  Patient problems: Failure of Implant; Pain; Unspecified Infection

  MAUDE report 6999201 ↗
• InjuryJun 6, 2017Unintended Movement; Unintended Movement

  IT WAS REPORTED THE PATIENT PRESENTED WITH A PRE-OPERATIVE DIAGNOSIS OF FAILED RIGHT TOTAL HIP ARTHROPLASTY WITH MALPOSITIONED FEMORAL COMPONENT AND PAIN. REVISION WAS PERFORMED TO REPLACE THE ACETABULAR CUP, FEMORAL COMPONENT, AND HEAD.

  Patient problems: Pain

  MAUDE report 6615875 ↗

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