Trident 542-11-54FRecalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 07613327037203), received between Feb 10, 2017 and Mar 17, 2026 — classified as 21 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (7 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, 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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• InjuryMar 17, 2026Unstable; Loss of Osseointegration

  UPDATE: ADDITIONAL INFORMATION RELATING TO THIS EVENT WAS DISCOVERED THROUGH THE CLINICIAN REVIEW OF THE PROVIDED MEDICAL RECORDS. THE MED REVIEW STATES 'LOOSENING OF AN ACETABULAR CUP WITH SPIN OUT 16 YEARS FOLLOWING THE INDEX PROCEDURE IS UNUSUAL IF THE PATIENT HAD NO PRIOR SYMPTOMS. THIS PATIENT DID HAVE EVIDENCE OF SOME BLACK MATERIAL IN AND AROUND THE FEMORAL HEAD.'

  Patient problems: Inadequate Osseointegration; Joint Laxity; Pain

  MAUDE report 24616796 ↗
• InjuryFeb 6, 2025Loss of Osseointegration; Loss of Osseointegration

  AS REPORTED BY CUSTOMERS SOLICITOR: ON OR AROUND (B)(6) 2008 THE CLAIMANT UNDERWENT A LEFT HIP REPLACEMENT WITH A FOLLOW UP OPERATION ON OR AROUND THE (B)(6) 2009. IT IS SUBMITTED THAT THE IMPLANTS SUPPLIED WERE DEFECTIVE AND DUE TO THE SAME THE CLAIMANT'S HIP BECAME INFECTED SUBJECTING THE CLAIMANT TO WORSENING HIP PAIN FROM (B)(6) 2023 ONWARDS. FOLLOWING INVESTIGATIONS, IT WAS DISCOVERED THAT CORROSION OF THE IMPLANTS WAS THE CAUSE OF THE ONGOING INFECTION/SYMPTOMS NECESSITATING THE REMOVAL AND REPLACEMENT OF THE DEFECTIVE IMPLANTS. THIS REVISION SURGERY TOOK PLACE IN (B)(6) 2023. UPDATE AS PER MEDICAL REVIEW: A LOOSE ACETABULAR COMPONENT WAS ALSO NOTED.

  Patient problems: Bacterial Infection

  MAUDE report 21320952 ↗
• InjuryMay 4, 2023Device Dislodged or Dislocated; Insufficient Device Problem Information; Device Dislodged or Dislocated; Insufficient Device Problem Information

  THE FOLLOWING WAS REPORTED: PATIENT HAD SECOND HIP REVISION PROCEDURE IN TWO MONTHS. HER THIRD HIP REVISION PROCEDURE IN TOTAL. ON THIS LATEST OCCASION, HER HIP PROSTHESIS HAD DISLOCATED SIMILAR TO THE PREVIOUS EVENT. SPECIFICALLY, SHE HAD A TRIDENT CONSTRAINED INSERT IN-SITU AND THE BIPOLAR HEAD HAD DISLOCATED FROM THE INSERT THAT IT HAD BEEN PRE-ASSEMBLED IN. THE INSERT WAS STILL IN THE ACETABULAR SHELL BUT THE BIPOLAR HEAD WAS COMPLETELY DISENGAGED FROM IT. THE BIPOLAR HEAD STILL HAD THE FEMORAL HEAD WITHIN IT WHICH ITSELF WAS STILL INTACT ON THE CONE BODY IMPLANT TRUNNION. UPDATE: AS PER INTAKE FORM, THE SURGEON EXPLANTED THE TRIDENT CONSTRAINED LINER, CERAMIC HEAD, TRIDENT CLUSTER SHELL, SCREWS AND THE CONE BODY.

  Patient problems: Joint Dislocation

  MAUDE report 16867156 ↗
• InjuryJan 10, 2022Malposition of Device; Malposition of Device

  AS REPORTED: "RIGHT SIDE HIP REVISION, ALL COMPONENTS EXPLANTED WERE STRYKER COMPONENTS. THE PATIENT WAS RE-IMPLANTED WITH ALL NEW REVISION COMPONENTS, AND THE CASE SHEET IS ATTACHED. THE ORIGINAL SURGERY WAS DONE IN 2011, THE PATIENT RECENTLY WAS REPORTING PAIN IN HIS RIGHT HIP, X-RAYS SHOWED ECCENTRIC WEAR ON THE POLYETHYLENE COMPONENT, AS WELL AS THE FEMORAL HEAD ON THE TRUNNION. THE PATIENT¿S COBALT CHROME LEVELS WERE ELEVATED, SO THE SURGEON DECIDED TO REVISE THE HIP COMPONENT. ADVERSE LOCAL TISSUE REACTIONS WERE MINIMAL, HOWEVER THE FEMORAL HEAD DID HAVE CORROSION AND FRETTING WAS NOTED ON THE TRUNNION. A PORTION OF THE SUPERIOR LIP OF THE POLYETHYLENE LINER WAS FRACTURED OFF. THE LOCKING MECHANISM WAS INTACT ON THE POLYETHYLENE/ACETABULAR COMPONENT JUNCTION, AND THE LINER WAS NOT DISASSOCIATED FROM THE ACETABULAR COMPONENT. ALL COMPONENTS WERE REMOVED." UPDATE: THE SHELL WAS REVISED BECAUSE THE SURGEON DIDN'T LIKE THE POSITION OF THE COMPONENT. THE DAMAGED PORTION OF THE LINER WAS THE PORTION THAT HAD THE LOT CODE ON IT THEREFORE IT WAS ILLEGIBLE.

  Patient problems: Foreign Body Reaction; Pain

  MAUDE report 13202867 ↗
• InjuryAug 25, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT CAME TO (B)(6) CLINIC COMPLAINING OF PROGRESSIVE HIP PAIN. AN X-RAY REVEALED A DISASSOCIATED FEMORAL HEAD DUE TO EXCESSIVE TRUNNION WEAR OF THE FEMORAL STEM. DURING SURGERY WAS NOTED THE TRUNNION HAD WORN TO THE POINT THAT THE FEMORAL HEAD HAD COME OFF. AFTER EXPLANTING THE ACCOLADE TMZF STEM A RESTORATION MODULAR STEM WAS USED AS THE REPLACEMENT DEVICE. *UPDATE ON 04-AUG-2021 PER MEDICAL REVIEW: POST-OPERATIVELY IT WAS STATED THAT THERE WAS CATASTROPHIC FAILURE OF THE HIP, TRUNNION FAILURE AT THE TAPER, METAL DISEASE, FEMORAL OSTEOLYSIS WITH A WELL FIXED STEM, WEAR THROUGH AND DESTRUCTION OF THE ACETABULUM, PERIACETABULAR OSTEOLYSIS AND ABDUCTOR DESTRUCTION.

  Patient problems: Osteolysis

  MAUDE report 12367774 ↗
• InjuryApr 29, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  AS REPORTED: "DR. EXPLANTED A TRIDENT PSL CLUSTER CUP, 1 TORX BONE SCREW, AND A DUAL MOBILITY CONSTRUCT CONSISTING OF A X3 POLY LINER WITH A 28MM METAL FEMORAL HEAD. INFORMATION ON THE ORIGINAL SURGERY (HOSPITAL, PHYSICIAN, DATE) WERE NOT PROVIDED IN ANY PATIENT NOTES. THE EXPLANTED ITEMS WERE KEPT BY REQUEST OF THE HOSPITAL SO THEY WERE NOT ABLE TO BE COLLECTED AND LOT#¿S WERE UNABLE TO BE OBTAINED, EITHER. AFTER EXPLANTING THE ITEMS, DR. PROCEEDED TO IMPLANT A TRIDENT 2 TRITANIUM MULTI HOLE CUP WITH A 0º 36 X3 LINER AND A 36MM DELTA CERAMIC HEAD." SPOKE TO REP: PATIENT'S RIGHT HIP WAS REVISED DUE TO PAIN. CONFIRMED THAT NO FURTHER INFORMATION WOULD BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Pain

  MAUDE report 11746206 ↗
• InjuryNov 17, 2020Malposition of Device; Device Dislodged or Dislocated; Malposition of Device; Device Dislodged or Dislocated

  THIS PI IS FOR THE (B)(6) 2016 SURGERY: "...SUBJECTED TO A NEW REVISION SURGERY OF THE HIP PROSTHESIS, WITH 'REPOSITIONING OF THE ACETABULAR COMPONENT OF THE IMPLANT', AND THEN DISCHARGED ON (B)(6) 2016, WITH THE DIAGNOSIS OF 'DISLOCATION RESULTING IN RIGHT HIP PROSTHESIS. ALLERGIC HISTORY, ANEMIA. SURGICAL WOUND DEHISCENCE. LOCAL ANTIBIOTIC THERAPY'." THE LAWYER OF THE PATIENT REPORTED THAT ON (B)(6) 2016, THE PATIENT UNDERWENT A TOTAL PROSTHESIS SURGERY OF THE RIGHT HIP. THE PATIENT WENT TO THE HOSPITAL ON (B)(6) 2016, DUE TO SEVERE PAIN IN THE RIGHT HIP CAUSED BY A RIGHT COXARTHROSIS, FOR WHICH THE DOCTORS WHO VISITED HER RECOMMENDED SURGERY FOR THE "PROSTHETIC REPLACEMENT OF THE HIP" DURING THE HOSPITAL STAY, AFTER THE FIRST SURGERY, THEN SEVERAL EPISODES OF DISLOCATION OF THE RECENTLY IMPLANTED PROSTHESIS, FOR WHICH THE PATIENT, ON (B)(6) 2016, UNDERWENT A NEW REDUCTION OPERATION, BY THE SURGEONS, AND WAS THEN DISCHARGED ON (B)(6) 2016. FOUR DAYS AFTER THE DISCHARGE OCCURRED A NEW EPISODE OF DISLOCATION, AS A RESULT OF WHICH SHE WAS ONCE AGAIN HOSPITALIZED AND, ON (B)(6) 2016, SUBJECTED TO A NEW REVISION SURGERY OF THE HIP PROSTHESIS, WITH "REPOSITIONING OF THE ACETABULAR COMP

  Patient problems: Joint Dislocation

  MAUDE report 10855044 ↗
• InjuryNov 4, 2020Malposition of Device; Device Dislodged or Dislocated; Malposition of Device; Device Dislodged or Dislocated

  THIS PI IS FOR REDUCTION OF A DISLOCATION ON (B)(6) 2016. THE LAWYER OF THE PATIENT REPORTED THAT ON (B)(6) 2016, THE PATIENT UNDERWENT A TOTAL PROSTHESIS SURGERY OF THE RIGHT HIP. THE PATIENT WENT TO THE HOSPITAL ON (B)(6) 2016, DUE TO SEVERE PAIN IN THE RIGHT HIP CAUSED BY A RIGHT COXARTHROSIS, FOR WHICH THE DOCTORS WHO VISITED HER RECOMMENDED SURGERY FOR THE "PROSTHETIC REPLACEMENT OF THE HIP" DURING THE HOSPITAL STAY, AFTER THE FIRST SURGERY, THEN SEVERAL EPISODES OF DISLOCATION OF THE RECENTLY IMPLANTED PROSTHESIS, FOR WHICH THE PATIENT, ON (B)(6) 2016, UNDERWENT A NEW REDUCTION OPERATION, BY THE SURGEONS, AND WAS THEN DISCHARGED ON (B)(6) 2016. FOUR DAYS AFTER THE DISCHARGE OCCURRED A NEW EPISODE OF DISLOCATION, AS A RESULT OF WHICH SHE WAS ONCE AGAIN HOSPITALIZED AND, ON (B)(6) 2016, SUBJECTED TO A NEW REVISION SURGERY OF THE HIP PROSTHESIS, WITH "REPOSITIONING OF THE ACETABULAR COMPONENT OF THE IMPLANT", AND THEN DISCHARGED ON (B)(6) 2016, WITH THE DIAGNOSIS OF "DISLOCATION RESULTING IN RIGHT HIP PROSTHESIS. ALLERGIC HISTORY, ANEMIA. SURGICAL WOUND DEHISCENCE. LOCAL ANTIBIOTIC THERAPY ". ON (B)(6) 2016, THE PATIENT WAS TRANSFERRED TO A REHABILITATION FACILITY WITH DIAGNOSIS

  Patient problems: Joint Dislocation

  MAUDE report 10786272 ↗
• InjuryJun 23, 2020Malposition of Device; Malposition of Device

  PATIENTS HIP WAS REVISED FOR DISLOCATION. ALL IMPLANTS WERE REMOVED AND REPLACED WITH TRIDENT II TRITANIUM MULTIHOLE SHELL, MDM LINER, SECURFIT STEM AND 28MM BIOLOX HEAD. THIS IS THE SECOND REVISION. UPDATE 01/JUNE/2020 WG: LEFT HIP (PATIENT HAS HAD BILATERAL REVISIONS. THE SHELL AND SCREW (IMPLANTED (B)(6) 2016), LINER, HEAD, SLEEVE, STEM (IMPLANTED (B)(6) 2020) WERE REVISED. UPDATE: "THE STEM WAS REVISED BECAUSE IT WAS UNDERSIZED AND HAD ALREADY HAD A MULTIPLE HEADS ON THE TRUNION. THE SURGEON WANTED TO PROPERLY SIZE THE FEMORAL STEM AND WANTED A FRESH TRUNION. THE SHELL WAS REVISED FOR INADEQUATE ANTEVERSION. THE DISLOCATION WAS OF THE FEMORAL HEAD OUT OF THE LINER. THE SURGEON DECLINED ANY FURTHER INFORMATION."

  Patient problems: Injury

  MAUDE report 10183970 ↗
• InjurySep 26, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT DISLOCATED THEIR CONSTRAINED LINER FROM THE CUP AGAIN ON (B)(6) 2019. ON LINER WAS REVISED TO A CONSTRAINED LINER, TRIDENT CONSTRAINED ACETABULAR INSERT, SIZE F, REF CODE: 690-00-28F, LOT: LW556T PATIENT HAS TERTIARY SYPHILIS. THIS HAS MANIFESTED IN THE FOLLOWING WAYS ACCORDING TO THE TREATING MEDICAL TEAM, LOSS OF MUSCULAR CONTROL AND INHIBITION FOR NEUROLOGICAL FUNCTION. IS UNABLE TO UNDERSTAND OR FOLLOW DIRECTIONS AND DAILY PUTS THEIR HIPS IN EXTREME RANGES OF MOTION, AS A CONSEQUENCE OF THEIR CONDITION. THIS PATIENT'S ORIGINAL SURGERY WAS ON(B)(6) 2019 AND IT WAS FIRST REVISED ON 12.6.19 FOR DISLOCATION. PATIENT REVISED AGAIN (B)(6) 2019 AFTER A DISASSOCIATION OF A CONSTRAINED LINER ON (B)(6) 2019.

  Patient problems: Injury; Joint Dislocation

  MAUDE report 9123635 ↗
• InjuryAug 28, 2019Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED FOR SHELL LOOSENING. THE SHELL, POLY LINER, AND CERAMIC HEAD WERE REVISED TO A STRYKER REVISION SHELL WITH A BIOLOX HEAD AND A POLY LINER. REP CONFIRMED THAT THERE ARE NO ALLEGATIONS AGAINST THE REVISED HEAD OR LINER, AND REPORTED THAT NO FURTHER INFORMATION WILL BE AVAILABLE.

  Patient problems: Inadequate Osseointegration; Injury

  MAUDE report 8939380 ↗
• MalfunctionJun 17, 2019Contamination /Decontamination Problem; Contamination /Decontamination Problem

  PRIMARY PROCEDURE, LEFT HIP. IT WAS REPORTED THAT WHEN THE OUTER STERILE BLISTER WAS OPENED, WHAT APPEARED TO BE A HAIR WAS INSIDE. DUE TO STERILITY CONCERNS, THE INNER STERILE BLISTER WAS NOT OPENED AND THE DEVICE WAS NOT USED. ANOTHER DEVICE WAS OBTAINED AND USED. SURGERY WAS COMPLETED SUCCESSFULLY WITH A SURGICAL DELAY OF APPROXIMATELY 1-2 MINUTES. DEVICE AND PACKAGING IS AVAILABLE FOR RETURN. OTHERWISE, NO FURTHER INFORMATION WILL BE AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8703573 ↗
• InjuryMay 20, 2019Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE PATIENT'S HIP WAS REVISED DUE TO STEM SUBSIDENCE AND SHELL LOOSENING. PATIENT FACTORS AS REPORTED BY REP: "RENAL FAILURE PATIENT. DIALYSIS PATIENT WITH (B)(6)¿NO OBVIOUS INFECTION". REP PROVIDED A PRE-REVISION X-RAY AND REPORTED THAT NO FURTHER INFORMATION WILL BE AVAILABLE.

  Patient problems: Inadequate Osseointegration; Injury

  MAUDE report 8623958 ↗
• InjuryApr 29, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT PRESENTED AT CLINIC WITH HIP PAIN. PRIMARY CUP AND SCREWS OUT. TRIDENT TRITANIUM REVISION CUP AND GAP PLATE SCREWS IN. UPDATE: "PATIENT PRESENTED AT CLINIC WITH HIP PAIN. PRIMARY CUP, LINER, AND SCREWS EXPLANTED. TRIDENT TRITANIUM REVISION CUP, MDM LINER, AND GAP PLATE SCREWS IN."

  Patient problems: Injury; Pain

  MAUDE report 8561772 ↗
• InjuryFeb 5, 2019Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO STEM LOOSENING AND SHELL LOOSENING. PATIENT'S HIP CONSTRUCT WAS REVISED TO A RESTORATION MODULAR STEM CONSTRUCT WITH A HEAD AND LINER AND TRIDENT II MULTI-HOLE SHELL.

  Patient problems: Inadequate Osseointegration; Injury

  MAUDE report 8304791 ↗
• InjuryNov 26, 2018Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT PATIENT'S RIGHT HIP WAS REVISED DUE TO SHELL MIGRATION. ON EXPLANTATION OF THE SHELL AND TWO SCREWS, A MINIMAL AMOUNT OF BONE ONGROWTH WAS OBSERVED ON THE SHELL. SURGEON'S ORIGINAL INTENTION WAS TO REVISE ONLY THE SHELL AND LINER TO COMPETITOR DEVICES. INTRA-OPERATIVELY, SURGEON DECIDED TO CHANGE PATIENT'S VERSION AS THE COMPETITOR SHELL LEFT THE PATIENT'S LIMB LENGTH SUBOPTIMAL WITH THE EXISTING STRYKER STEM AND HEAD. A STRYKER SHELL WITH 2 SCREWS, LINER, HEAD, AND STEM WERE REVISED TO A COMPETITOR SHELL AND LINER WITH A STRYKER HEAD AND STEM. REP PROVIDED A PRE-REVISION X-RAY AND REPORTED THAT ADDITIONAL X-RAYS, MEDICAL RECORDS, AND FURTHER INFORMATION WOULD NOT BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Inadequate Osseointegration; Injury

  MAUDE report 8104394 ↗
• InjuryOct 29, 2018Material Deformation; Material Deformation

  IT WAS REPORTED THROUGH THE ATTORNEY FOR THE PATIENT, AS A RESULT OF A LEGAL CLAIM, THAT ALLEGEDLY THE PATIENT UNDERWENT RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2006. IT IS FURTHER ALLEGED, "IN (B)(6) 2011, HE LOST CONTROL OF HIS RIGHT LEG WHILE GETTING UP FROM HIS OFFICE CHAIR. RADIOGRAPHS SHOWED A COMPLETE DISASSOCIATION OF THE FEMORAL HEAD FROM THE STEM WITH THE TRUNNION EXTENDING INTO THE ACETABULAR CUP." THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2011. ON (B)(6) 2011 A REVISION OF THE RIGHT TOTAL HIP WAS PERFORMED FOR RIGHT HIP INSTABILITY WITH DISASSOCIATION FEMORAL HEAD FROM STEM. THE FINDINGS WERE, " METAL STAINING SYNOVIUM, SYNOVIAL FLUID AND PSEUDOCAPSULE. FEMORAL HEAD DISASSOCIATED. DAMAGE TO POLY LINER WITH FULL THICKNESS WEAR AND MINIMAL DAMAGE TO SHELL. SUPERIOR SCRATCHES ON THE TRUNNION SIGNIFICANTLY, IT WASN'T POSSIBLE TO ATTACHED A NEW HEAD.

  Patient problems: Inflammation; Injury; Joint Dislocation; Reaction

  MAUDE report 8017386 ↗
• InjurySep 28, 2018Material Deformation; Material Deformation

  ON (B)(6) 2011 A REVISION OF THE RIGHT TOTAL HIP WAS PERFORMED FOR RIGHT HIP INSTABILITY WITH DISASSOCIATION FEMORAL HEAD FROM STEM. THE FINDINGS WERE, " METAL STAINING SYNOVIUM, SYNOVIAL FLUID AND PSEUDOCAPSULE. FEMORAL HEAD DISASSOCIATED. DAMAGE TO POLY LINER WITH FULL THICKNESS WEAR AND MINIMAL DAMAGE TO SHELL. SUPERIOR SCRATCHES ON THE TRUNNION SIGNIFICANTLY, IT WASN'T POSSIBLE TO ATTACHED A NEW HEAD.

  Patient problems: Inflammation; Injury; Joint Dislocation; Reaction

  MAUDE report 7919044 ↗
• InjuryJul 2, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  TOOK THE ACCOLADE 1 STEM OUT AND WENT BACK WITH A REST MOD AND AN MDM LINER AND HEAD. "ON (B)(6) 2013 SHE WAS SEEN IN AN EMERGENCY ROOM VISIT FOR PAIN IN THE RIGHT HIP OF TWENTY-FOUR HOURS DURATION AND IT WAS NOTED, "FELL ON RIGHT SIDE YESTERDAY ... X-RAY RIGHT: PERIPROSTHETIC ACETABULAR FRACTURE. TREAT: NON-WEIGHTBEARING WITH A WALKER...ON (B)(6) 2016 A REVISION RIGHT TOTAL HIP ARTHROPLASTY, INCLUDING THE FEMORAL STEM, HEAD AND ACETABULAR LINER WAS PERFORMED FOR A POST-OPERATIVE DIAGNOSIS OF "BROKEN INTERNAL PROSTHESIS RIGHT HIP...X-RAY OF (B)(6) 2016 IS AN AP PELVIS DEMONSTRATING DISASSOCIATION OF FEMORAL TRUNNION FROM ARTHROPLASTY HEAD WHICH REMAINS IN THE ACETABULUM. TRUNNION DEFORMITY IS NOTED..."

  Patient problems: Bone Fracture(s); Fall; Injury; Pain

  MAUDE report 7654990 ↗
• InjuryJun 28, 2018Loss of Osseointegration; Malposition of Device; Insufficient Device Problem Information; Loss of Osseointegration; Malposition of Device; Insufficient Device Problem Information

  IT WAS REPORTED BY THE ATTORNEY, THROUGH THE FILING OF A LAWSUIT, THAT THE PLAINTIFF UNDERWENT A RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2015 WHERE SHE WAS IMPLANTED WITH A STRYKER SECUR-FIT MAX SYSTEM. IT IS FURTHER ALLEGED THAT "IN THE SPRING OF 2016, PLAINTIFF BEGAN EXPERIENCING EXTREME PAIN AND DISCOMFORT IN HER LOWER BACK AND RIGHT HIP. SHE HAD DIFFICULTY WALKING AND REQUIRED THE USE OF A CRUTCH TO GET AROUND". THE PATIENT'S RIGHT HIP WAS THEN REVISED ON (B)(6) 2016. DR. (B)(6) STATED IN HIS OPERATIVE REPORT THAT "ONE OF THE SCREW HEAD [SIC] WAS BROKEN AND WAS REMOVED AND THEN THE CUP REMOVED". DR. (B)(6) ALSO NOTED THAT AN "ADDITIONAL BROKEN SCREW WAS REMOVED USING HAND INSTRUMENTS".

  Patient problems: Ambulation or Postural Difficulties; Discomfort; Inadequate Osseointegration; Injury; Pain

  MAUDE report 7645754 ↗
• InjuryJun 21, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT FRACTURE CERAMIC INSERT OF LEFT HIP. AS REPORTED IN ADVERSE CONSEQUENCE DETAILS: "REVISED STEM AND CUP AS IT BECAME APPARENT DURING SURGERY THAT THE FEMORAL [NECK] WAS COMPROMISED DUE TO IMPINGEMENT". ALUMINA HEAD AND 2 SCREWS WERE ALSO REPORTED EXPLANTED PER PRODUCT GRID.

  Patient problems: Injury

  MAUDE report 7626875 ↗
• InjurySep 12, 2017Loss of Osseointegration; Loss of Osseointegration

  PATIENT HAD PRIMARY TOTAL HIP REPLACEMENT AND NEEDED TO RETURN TO THE OPERATING ROOM IN 11 DAYS DUE TO A PERI-PROSTHETIC FEMUR FRACTURE (B2). DURING SURGERY THE ACETABULUM WAS NOTED TO BE LOOSE. ALL COMPONENTES EXCHANGED.

  Patient problems: Bone Fracture(s); Inadequate Osseointegration; Injury

  MAUDE report 6858967 ↗
• MalfunctionFeb 10, 2017Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  OUR DISTRIBUTOR REPORTED THAT DURING A SURGERY THE THREAD LENGTH PROTRUDING PAST THE DOME OF THE ACETABULAR TRIAL AND IMPLANT OF 54MM, AND IT WAS VERY DIFFICULT TO IMPLANT. SEEMS THAT WITH OTHER SIZE OF TRIAL THE PROBLEM DID NOT OCCUR.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6322387 ↗