Trident 542-11-50ERecalls & reported problems

Summary

The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 07613327037265), received between Feb 9, 2017 and Nov 1, 2024 — classified as 33 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Malposition of Device” (11 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 25 most recent of 35 reports, in the reporter's own words as published by the FDA.

• InjuryNov 1, 2024Loss of Osseointegration; Malposition of Device; Loss of Osseointegration; Malposition of Device

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO SHELL MIGRATION AND LOOSENING AFTER THE PATIENT SUFFERED A FALL. THE SHELL, A SCREW, HEAD, AND LINER WERE REVISED. THERE WERE NO ALLEGATIONS AGAINST THE REVISED HEAD OR LINER. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 20591393 ↗
• InjuryMar 1, 2024Loss of Osseointegration; Loss of Osseointegration

  REP WAS NOTIFIED THAT A REVISION WAS PERFORMED ON PATIENT'S LEFT HIP. INITIALLY, THE REASON FOR REVISION WAS THAT THE SHELL 'SPUN OUT.' INTRA-OPERATIVELY, TRUNNION WEAR WAS ALSO NOTED. THE PATIENT'S HIP CONSTRUCT WAS CONVERTED TO A COMPETITOR HIP. REP WILL PROVIDE ALL INFORMATION AVAILABLE TO HIM FROM THE HOSPITAL AND SURGEON.

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 18814770 ↗
• InjuryDec 20, 2022Material Erosion; Material Erosion

  AS REPORTED: "PERFORMED A LEFT HIP REVISION DUE TO ALTR. HE EXPLANTED THE INSERT, LINER AND BIOLOX HEAD. NO MORE INFORMATION IS AVAILABLE PER DOCTOR." REP CONFIRMED THERE WERE NO ALLEGATIONS AGAINST THE TRUNNION (I.E. WEAR, ETC).

  Patient problems: Metal Related Pathology

  MAUDE report 16019043 ↗
• InjuryNov 29, 2022Loss of Osseointegration; Loss of Osseointegration

  ASEPTIC MOBILIZATION OF THE RIGHT CUP. REVISION.

  Patient problems: Inadequate Osseointegration

  MAUDE report 15883250 ↗
• InjuryOct 21, 2022Malposition of Device; Malposition of Device

  PATIENT REPORTED HE HAD A LEFT THA ON (B)(6) 2013. PATIENT STARTED TO EXPERIENCE POPPING WHEN WALKING AND VISION ISSUES APPROX TWO YEARS AGO. IN (B)(6) OF 2021 HIS TASTE BUDS CHANGED AND HE STARTED TO EXPERIENCE PAIN. PATIENT STATED HE HAS BEEN UNABLE TO WORK SINCE (B)(6) 2022 DUE TO HIS PAIN. PATIENT WOULD LIKE TO KNOW IF HIS IMPLANTS ARE PART OF A RECALL. UPDATE PER CONVERSATION WITH PATIENT: PATIENT STATED HE WAS EXPERIENCING VISION PROBLEMS, MUSCLE ACHES AND POPPING OF HIP. UPDATE 29-SEPTEMBER-2022 MF: PER MEDICAL REVIEW: "THE FEMORAL COMPONENT AND FEMORAL HEAD APPEAR SATISFACTORY. THE ACETABULAR COMPONENT IS MALPOSITIONED WITH WHAT APPEARS TO BE ALMOST A COMPLETELY VERTICAL POSITION. THERE APPEARS TO BE SOME POLYETHYLENE WEAR."THE MEDICAL RECORDS FURTHER INDICATE THAT REVISION SURGERY IS RECOMMENDED.

  Patient problems: Joint Laxity; Loss of Range of Motion; Muscle Weakness/Atrophy; Pain; Taste Disorder; Visual Impairment

  MAUDE report 15648774 ↗
• InjuryJul 25, 2022Malposition of Device; Malposition of Device

  IT WAS REPORTED THE PATIENT'S RIGHT HIP WAS REVISED. AS REPORTED: "CUP SPUN OUT OF ACETABULUM AND HEAD AND TRUNNION HAD CORROSION."

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 15099957 ↗
• InjuryJul 4, 2022Migration; Migration

  IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED DUE TO MIGRATION OF THE SHELL INTO A VERTICAL POSITION. THE SHELL, 2 SCREWS, HEAD AND LINER WERE REVISED. REP CONFIRMED THERE ARE NO ALLEGATIONS AGAINST THE REVISED HEAD AND LINER.

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 14905823 ↗
• InjuryDec 28, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE TRUNNION-HEAD OF THE ACCOLADE TMZF STEM FAILED AND REQUIRED REVISION. ON (B)(6) 2021: PICTURES REVEALED THAT THE SHELL WAS ALSO REVISED.

  Patient problems: Insufficient Information

  MAUDE report 13102508 ↗
• InjuryNov 11, 2021Loss of Osseointegration; Loss of Osseointegration

  PATIENTS ACETABULUM WAS REVISED FOR ASEPTIC LOOSENING. TRIDENT PSL 50MM SHELL WAS REVISED TO TRIDENT II TRITANIUM MULTIHOLE SHELL 58MM, ECCENTRIC F LINER, V40 TO C-TAPER SLEEVE, AND +2.5 36MM C-TAPER BIOLOX HEAD.

  Patient problems: Inadequate Osseointegration

  MAUDE report 12801150 ↗
• InjuryApr 9, 2021Loss of Osseointegration; Insufficient Device Problem Information; Loss of Osseointegration; Insufficient Device Problem Information

  ALL DEVICE WERE REMOVED DUE TO ARMD. PLEASE INVESTIGATE TRUNNION. AFTER SCREW WAS REMOVED, TRIDENT SHELL COULD BE REMOVED MANUALLY. PLEASE INVESTIGATE IF IN-GROWTH AND ON-GROWTH WAS ADVANCED AND IF THERE WAS ANY DEVICE ISSUE.

  Patient problems: Foreign Body Reaction; Inadequate Osseointegration

  MAUDE report 11640775 ↗
• InjuryNov 5, 2020Difficult to Insert; Inadequacy of Device Shape and/or Size; Difficult to Insert; Inadequacy of Device Shape and/or Size

  TOTAL HIP REPLACEMENT. CARRYING OUT THE ACETABULAR RHYME (REAM) IS RHYMED (REAMED) UP TO 50 AND THE FINAL CUP IS PASSED 50, WHEN FIXING IT WITH A 5.5 MM SCREW THE CUP IS LOOSENED AND THE PRESFIT IS LOST, WHICH FORCES THE SPECIALIST TO USE A LARGER CUP. DUE TO THE PROLONGATION OF THE SURGERY, THE PATIENT MUST BE TRANSFERRED TO THE ICU.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 10792324 ↗
• InjuryAug 4, 2020Unstable; Device Dislodged or Dislocated; Unstable; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO INSTABILITY AND DISLOCATION OF THE HEAD FROM THE POLY LINER. THE SHELL WAS REVISED DUE TO THE SURGEON NEEDING MORE ANTEVERSION. PATIENT WAS REVISED TO A 28MM + 12 MM L FIT V40 FEMORAL HEAD, A 28/52 MM RESTORATION ADM/MDM X3 INSERT, A 46 MM MDM CEMENTLESS LINER, AND 56 MM TRIDENT II CLUSTERHOLE HA SHELL WITH THREE 6.5MM X 15 MM SCREWS AND ONW 6.5 MM X 20 MM SCREW. REP CONFIRMED THAT NO FURTHER INFORMATION WOULD BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Injury

  MAUDE report 10364861 ↗
• InjuryJul 17, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO THE ACETABULAR SHELL PROTRUDING INTO THE PATIENT'S ACETABULUM. INTRA-OPERATIVELY, PSEUDOTUMOR WAS NOTED. SURGEON REPORTED THIS WAS LIKELY DUE TO IMPINGEMENT OF THE MDM LINER ON THE STEM, WHICH WAS SLIGHTLY NOTCHED. THE SHELL, MDM LINER, ADM INSERT, AND CERAMIC HEAD WERE REVISED TO A COMPETITOR SHELL AND LINER WITH ANOTHER STRYKER HEAD AND SLEEVE. REP CONFIRMED THERE ARE NO ALLEGATIONS AGAINST THE REVISED HEAD OR POLY INSERT, AND THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Injury

  MAUDE report 10288220 ↗
• InjuryJan 3, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  AS REPORTED: "LEFT TOTAL HIP REVISION. HIP PAIN." ON (B)(6) 2019. UPDATE 06-DEC-2019: RECEIVED A MEDWATCH (MW5091237) STATING "AFTER TOTAL HIP REPLACEMENT SURGERY, SWELLING BEYOND NORMAL, BLISTERING, THE OPEN OOZING FOR 4 MONTHS. JOINT PAINS EVERYWHERE. BRAIN FOG, BLURRED VISION, FATIGUE, DEPRESSION, ACCELERATED HEART RATE, HIGH BLOOD PRESSURE, ANXIETY, FALLING, SKIN HARDENING ON FEET AND FINGERTIP, NUMBNESS IN FINGERTIPS AND SINUSITIS. I ASK FOR THE COMPONENTS COMPOSITION AND IN ME IS NICKEL 1.0 MAX. I HAVE JUST COMPLETED MY LEFT REVISION SURGERY ON [...]2019. I STILL HAVE TO HAVE THE RIGHT HIP REVISED." ON (B)(6) 2019: SPOKE TO PATIENT, SHE STATED SHE STILL HAS PAIN AFTER HER LEFT HIP REVISION SURGERY. PATIENT ALSO STATED SHE HAD A RIGHT HIP REPLACEMENT DONE ON (B)(6) 2018 AND IS EXPERIENCING PAIN. PATIENT SAID SHE NEEDS A REVISION SURGERY AND WILL SCHEDULE IT SOON.

  Patient problems: Anxiety; Fall; Injury; Joint Swelling; Pain

  MAUDE report 9547793 ↗
• InjuryOct 18, 2019Mechanical Problem; Mechanical Problem

  THIS PI IS FOR THE REVISION OF THE PATIENT'S LEFT HIP ON (B)(6) 2019. PROCEDURE: THE PATIENT UNDERWENT LEFT HIP REPLACEMENT (B)(6) 2013. THE PATIENT UNDERWENT FAILED LEFT TOTAL HIP REVISION, FEMORAL COMPONENT GROSSLY LOOSENED AND REMOVED (B)(6) 2015. PATIENT HAD SEVERE PAIN AND DYSFUNCTION AND MECHANICAL COMPLICATION OF PREVIOUS LEFT TOTAL HIP REVISION. ALL COMPONENTS EXCHANGED EXCEPT FEMUR ON (B)(6) 2019.

  Patient problems: Injury; Pain

  MAUDE report 9208550 ↗
• InjuryOct 16, 2019Malposition of Device; Device Dislodged or Dislocated; Positioning Problem; Malposition of Device; Device Dislodged or Dislocated; Positioning Problem

  PATIENT STOOD UP AND DISLOCATED HIS HIP. THE EVENT OCCURRED OUT OF HOSPITAL. DR BELIEVED THAT BY REPOSITIONING THE ACETABULAR SHELL, IT WOULD SOLVE THE PROBLEM OF DISLOCATION IN THE FUTURE. THE FEMORAL HEAD AND ACETABULAR COMPONENTS WERE REMOVED AND REPLACED THIS NEW IMPLANTS.

  Patient problems: Injury; Joint Dislocation

  MAUDE report 9196791 ↗
• InjurySep 27, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  WHEN IMPACTING A TRIDENT PSL 50 CUP, THE MAGNETISED OFFSET CUP IMPACTOR BOLT (1440-2011) GOT STUCK IN THE DEFINITIVE CUP & COULDN'T BE DETACHED. THE SURGEON HAD TO DISLODGE THE CUP, TAKE IT OUT, REAM UP AND IMPLANT A 52 PSL CUP WITH A DIFFERENT IMPACTOR (THE STANDARD TRIDENT CUP IMPACTOR). UPON DISLODGING THE CUP TO TAKE IT OUT, THE ANTERIOR COLUMN FRACTURED. APPROX 5-10 MINUTES SURGICAL DELAY.

  Patient problems: Bone Fracture(s)

  MAUDE report 9128719 ↗
• InjuryFeb 19, 2019Osseointegration Problem; Osseointegration Problem

  POSTOPERATIVE DIAGNOSIS: PATIENT UNDERWENT PRIMARY THA (B)(6) 2013 AND SUBSEQUENT REVISION SURGERY ON (B)(6) 2015 FOR ILIOPSOAS TENDINITIS SYMPTOMOLOGY. CORROSION IN CUP SCREW, ACETABULAR CUP FOUND TO BE LOOSE. ALL COMPONENTS REVISED EXCEPT FEMUR.

  Patient problems: Inadequate Osseointegration; Injury

  MAUDE report 8352330 ↗
• InjuryJan 31, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT'S RIGHT HIP WAS REVISED DUE TO ADVERSE LOCAL TISSUE REACTION. REP REPORTED THAT HE PROVIDED ALL MEDICAL RECORDS AVAILABLE BY HOSPITAL POLICY TO HIM. CORRECTION AS PER UPDATE RECEIVED TUESDAY JANUARY 22ND 2019: THE TRIDENT SHELL IN SITU FROM (B)(6) 2008 WAS REVISED (B)(6) 2018 (ALTR), NOT ON (B)(6) 2018. AT THAT TIME, AN ALL-POLY CONSTRAINED LINER WAS CEMENTED INTO THE PATIENT¿S NATIVE ACETABULUM.

  Patient problems: Inflammation; Injury; Reaction

  MAUDE report 8292677 ↗
• InjuryJan 22, 2019Malposition of Device; Osseointegration Problem; Malposition of Device; Osseointegration Problem

  IT WAS REPORTED THAT THE PATIENT, "HAD A TRIDENT HEMISPHERICAL RIGHT HIP REPLACEMENT SURGERY ON (B)(6) 2006." IT IS FURTHER REPORTED THAT, "ON (B)(6) 2007, THE PATIENT UNDERWENT REVISION OF THE RIGHT HIP." PER REVIEW OF MEDICAL RECORDS [...] "ON (B)(6) 2007 IT WAS NOTED SHE "BEGAN TO NOTICE SQUEAKING ON RIGHT HIP SINCE (B)(6) 2007, INCREASING, AND NOW GRINDING-LIKE AND RUSTY DOOR CLOSING".[...]IT WAS NOTED THAT HER HIP "READILY SQUEAKS AS SHE WALKS THROUGH THE OFFICE" AND THAT THE "SQUEAK IS UNACCEPTABLE TO HER''..."ON (B)(6) 2007 A REVISION OF THE RIGHT TOTAL HIP ARTHROPLASTY WAS PERFORMED FOR WHICH AN OPERATIVE REPORT DESCRIBES REGIONAL ANESTHESIA AND A POSTEROLATERAL APPROACH FOR A DIAGNOSIS OF ASEPTIC FAILURE DUE TO BEARING SURFACE WEAR AND IMPLANT FAILURE. DURING SURGERY THE "CERAMIC HEAD HAD A LARGE FOCUS OF STRIPE WEAR". THE ACETABULAR COMPONENT WAS "NOTED TO BE MODERATELY VERTICAL AND SEVERELY ANTEVERTED AT AROUND 60°". THREE SCREWS WERE REMOVED AFTER THE LINER AND THE CUP WAS REMOVED WITH THE IMPLEX ACETABULAR OSTEOTOME DEVICE WITH MINIMAL EVIDENCE OF BONE INGROWTH. "

  Patient problems: Inadequate Osseointegration; Injury

  MAUDE report 8267697 ↗
• InjuryJan 3, 2019Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT PATIENT'S RIGHT HIP WAS REVISED AS THE ACETABULAR COMPONENT WAS PULLING OUT OF THE PATIENT'S ACETABULUM DUE TO THE CEMENT MANTLE NOT INTERDIGITATING WITH THE PATIENT'S NATIVE BONE. SURGEON REPORTED THAT THERE ARE NO ALLEGATIONS AGAINST ANY STRYKER DEVICES, BUT THAT PATIENT FACTORS (REPORTED AS "SICK AND UNHEALTHY") WERE THE CAUSE. A TRIDENT ALL POLY CONSTRAINED ACETABULAR INSERT (CEMENTED) AND A 32 +7.5 C-TAPER LFIT HEAD WERE REVISED TO AN RAS CUP WITH AN ADM/MDM LINER CONSTRUCT (REVISION HEAD NOT REPORTED). UPDATE 06 DEC 2018: TRIDENT SHELL CATALOG # 542-11-50E LOT # LYNMEE WAS IMPLANTED ON (B)(6) 2008 AND EXPLANTED ON (B)(6) 2018. THE TRIDENT SHELL HAS BEEN ADDED TO THE PRODUCT GRID.

  Patient problems: Inadequate Osseointegration; Injury

  MAUDE report 8214674 ↗
• InjuryDec 28, 2018Unstable; Unstable

  PATIENT HAD COMPLAINED OF SUBLUXATION AND GRINDING OF HIP JOINT THAT WAS REPLACED IN 2007. WHEN SURGEON OPERATED AND DISLOCATED THIS JOINT THE CERAMIC LINER WAS FOUND TO HAVE A WORN SUPERIOR ASPECT OF THE LINER. SURGEON PERFORMED AN ACETABULAR REVISION. THE WORN LINER WAS NOTICED INTRAOPERATIVELY, HOWEVER THE PATIENT HAD BEEN COMPLAINING OF INSTABILITY PREVIOUSLY.

  Patient problems: Injury

  MAUDE report 8204099 ↗
• InjuryDec 28, 2018Malposition of Device; Device Dislodged or Dislocated; Malposition of Device; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THA WAS DONE WITH TRIDENT HA SHELL AND X3 LINER AND STEM. THE SHELL WAS DISLOCATED IN ABOUT ONE YEAR AFTER THA. THEREFORE, ALL DEVICES WERE REMOVED AND REVISION SURGERY WAS DONE. THE REMOVED POLYETHYLENE LINER WAS YELLOWISH DISCOLORED. UPDATE DEC 17, 2018- CAUSE OF REVISION SHELL WAS DISLOCATED (MALPOSITION).

  Patient problems: Injury

  MAUDE report 8203902 ↗
• InjuryNov 5, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  REVISION HIP ARTHROPLASTY PERFORMED. 32MM STANDARD V40 ALUMINA HEAD WAS REMOVED. ALPHA CODE E 32MM ALUMINA INSERT WAS REMOVED. TRIDENT PSL 50MM ACETABULAR SHELL WAS REMOVED. ACETABULAR SHELL REPLACED WITH A BIOMET SHELL AND POLY LINER. STRYKER V40 36MM PLUS 5 L-FIT HEAD WAS IMPLANTED ON AN ACCOLADE I STEM THAT REMAINED. UPDATE (B)(6) 2018: SURGEON REPORTED REASON FOR REVISION IS PAIN. REP PROVIDED PRE-REVISION X-RAYS.

  Patient problems: Injury; Pain

  MAUDE report 8039331 ↗
• InjuryOct 4, 2018Malposition of Device; Positioning Problem; Malposition of Device; Positioning Problem

  IT WAS REPORTED THAT PATIENT'S RIGHT HIP WAS REVISED THE SAME DAY IT WAS IMPLANTED. SURGEON REVIEWED POST-OP X-RAYS AND WASN'T SATISFIED WITH THE CUP'S POSITIONING. THE ORIGINAL CONSTRUCT EXCEPT THE STEM WAS REVISED.

  Patient problems: Injury

  MAUDE report 7935411 ↗