SMF, STIKTITERecalls & reported problems across all models

We found 6 models of SMF, STIKTITE by Smith & Nephew, Inc. in the FDA's device registry (GUDID). Together they are named in 38 adverse event reports in the FDA's MAUDE database, received between Jun 6, 2017 and Feb 27, 2024 — classified as 38 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (10 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported SMF, STIKTITE problems

SMF, STIKTITE models

6 models, most reported first. Each model has its own page with its reports, recalls and device details.

• SMF, STIKTITE 71352502

  PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
  17 reports
• SMF, STIKTITE 71352501

  PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
  8 reports
• SMF, STIKTITE 71352503

  PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
  6 reports
• SMF, STIKTITE 71352504

  PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
  3 reports
• SMF, STIKTITE 71352505

  PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
  3 reports
• SMF, STIKTITE 71352508

  PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
  1 report

Recent SMF, STIKTITE adverse event reports

The 15 most recent reports across all models, 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗

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