Trident II 702-04-52ERecalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 07613327343915), received between Nov 6, 2017 and Jun 11, 2026 — classified as 19 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Malposition of Device” (9 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 18, 2026.

Most reported problems

Recent adverse event reports

The 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• InjuryJun 11, 2026Malposition of Device

  THE FOLLOWING INFORMATION WAS PROVIDED: IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO SHELL MALPOSITION. IT WAS ROTATED DISTALLY, AND MIGRATED THROUGH THE ACETABULAR WALL. NO TRAUMA WAS REPORTED TO THE REP. THE SHELL, SCREWS, HEAD AND INSERT WERE REVISED TO ANOTHER SHELL, EVEN MORE SCREWS, MDM/ ADM LINER, AND FEMORAL HEAD. REP CONFIRMED THERE WERE NO ALLEGATIONS AGAINST THE REVISED LINER AND HEAD, AND THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Insufficient Information

  MAUDE report 25477774 ↗
• InjuryNov 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS REPORTED: "PATIENT REVISED DUE TO PELVIC FRACTURE. LINER, CUP, SCREW, MDM HEAD, INNER BEARING ALL EXPLANTED. RIGHT HIP. NO OTHER INFORMATION AVAILABLE DUE TO HOSPITAL POLICY."

  Patient problems: Bone Fracture(s)

  MAUDE report 23670282 ↗
• InjurySep 2, 2025Malposition of Device; Positioning Problem; Malposition of Device; Positioning Problem

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO RECURRENT DISLOCATIONS. AN ELEVATED RIM LINER AND CERAMIC HEAD WERE REMOVED. THE SURGEON REPORTED THAT THE SHELL WAS IMPLANTED IN A SUBOPTIMAL POSITION, SO REMOVED AND RE-IMPLANTED THE SHELL WITH ADDITIONAL SCREWS. A SLEEVE, FEMORAL HEAD, AND LINER WERE ALSO IMPLANTED. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Joint Dislocation

  MAUDE report 22931706 ↗
• InjuryAug 25, 2025Loss of Osseointegration; Loss of Osseointegration

  AS REPORTED: "REVISION LTHA - CUP LOOSE, REMOVED AND PUT IN COMPETITOR TM SHELL AND STRYKER NEW HEAD." REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Inadequate Osseointegration

  MAUDE report 22890481 ↗
• InjuryJul 24, 2025Loss of Osseointegration; Loss of Osseointegration

  PT. REPORTED; HAD RIGHT HIP IMPLANT IN (B)(6) 2022 AND HAD MANY PROBLEMS WITH THE IMPLANT. PT. MENTIONED LOOSENING, IMMOBILITY, BURSITIS AND WEAR. IMPENDING REVISION TO REPLACE JOINT AND THE LINER DUE TO WEAR.

  Patient problems: Ambulation or Postural Difficulties; Bursitis; Inadequate Osseointegration

  MAUDE report 22601333 ↗
• InjuryJun 30, 2025Use of Device Problem; Use of Device Problem

  PRIOR TO A MAKO ROBOTIC TOTAL HIP CASE, THE SURGEON WAS SHOWN THE PLAN AND WAS EXPLAINED BY THE MPS THAT THEY HAD SIZED THE CUP A SIZE 50. THE SURGEON NOTED THAT THE PATIENT HAD A SIZE 52 ON THEIR OTHER SIDE AND WANTED TO LOOK AT A SIZE 52 ON THE PLAN. THE MPS EXPLAINED THAT A SIZE 52 LOOKED TOO BIG AND THAT THE POSTERIOR WALL LOOKED TOO THIN WITH A 52. THE SURGEON WAS HAPPY TO PROCEED WITH A SIZE 52 AND WAS CAUTIONED BY THE MPS TO BE CAREFUL NOT TO OVER REAM AND TO BE GENTLE DURING CUP IMPACTION. THE CASE PROCEEDED WITH NO ISSUES, HOWEVER THE SURGEON DID REAM DEEP TO THE PLAN. DURING IMPACTION THE SURGEON IMPACTED VERY FORCEFULLY, AND REPORTED A CRACK IN THE POSTERIOR WALL OF THE ACETABULUM. THE SURGEON TOOK RESPONSIBILITY FOR THIS AND ACKNOWLEDGED THAT HE HAD HIT TOO HARD DURING IMPACTION, AND WAS OK TO PROCEED WITH NO FURTHER INTERVENTION BESIDES PUTTING SEVERAL SCREWS IN THE CUP. HE WAS HAPPY THAT THE CUP HAD GOOD FIXATION AND WAS STABLE WITH THE SCREWS. ROB509. THA 4.0. SURGICAL DELAY - 5-10 MINUTES WHILE SURGEON PUT ADDITIONAL STABILISING SCREWS IN ACETABULUM. PATIENT WILL ALSO BE REQUIRED TO FOLLOW A DIFFERENT PROTOCOL POST OPERATIVELY TO ENSURE FRACTURE HEALING.

  Patient problems: Bone Fracture(s)

  MAUDE report 22355950 ↗
• InjurySep 23, 2024Malposition of Device; Malposition of Device

  IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED AFTER PATIENT COMPLAINT OF PAIN. SURGEON REPORTED THE SHELL HAD 'SPUN OUT' AND INFECTION WAS ALSO SUSPECTED. THE PATIENT'S HIP CONSTRUCT WAS REMOVED AND A SPACER WAS PLACED. REP PROVIDED X-RAYS AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 20280958 ↗
• InjuryApr 3, 2024Failure to Osseointegrate; Failure to Osseointegrate

  REVISED A LEFT HIP CUP/LINER/HEAD DUE TO CUP ONLY HAVING FIBROUS INGROWTH.

  Patient problems: Inadequate Osseointegration

  MAUDE report 19037625 ↗
• InjuryNov 20, 2023Malposition of Device; Malposition of Device

  IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED DUE TO PSOAS IMPINGEMENT. INTRAOPERATIVELY, ABNORMAL WEAR WAS NOTED ON THE ELEVATED RIM OF THE LINER (EXACT CAUSE OF WEAR UNKNOWN). A SHELL, LINER AND HEAD WERE REVISED. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Muscle/Tendon Damage

  MAUDE report 18168712 ↗
• InjuryNov 8, 2023Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THE PATIENT'S LEFT HIP WAS REVISED DUE TO GROIN PAIN. SURGEON SUSPECTED IMPINGEMENT AND THE STEM WAS FOUND TO BE IN VARUS. THE PATIENT'S HIP CONSTRUCT WAS REVISED USING A 54 MULTI-HOLE SHELL, MDM METAL LINER WITH ADM/ MDM POLY INSERT, FEMORAL HEAD, AND SHORT 115 RESTORATION MODULAR STEM CONSTRUCT. REP CONFIRMED THERE WERE NO ALLEGATIONS AGAINST THE REVISED LINER AND HEAD, AND THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL AND SURGEON.

  Patient problems: Joint Impingement; Pain

  MAUDE report 18090050 ↗
• InjuryJan 13, 2023Loss of Osseointegration; Loss of Osseointegration

  AS REPORTED: "PATIENT'S RIGHT HIP REVISED DUE TO CUP BEING LOOSE." A SHELL, MDM METAL LINER, ADM/ MDM POLY INSERT AND CERAMIC FEMORAL HEAD WERE REVISED.

  Patient problems: Inadequate Osseointegration

  MAUDE report 16156336 ↗
• InjuryDec 8, 2022Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO RECURRENT DISLOCATIONS (SURGEON REPORTED THE REASON FOR THE DISLOCATIONS WAS DUE TO A COMPETITOR KNEE BEING IN EXTREME VALGUS WITH INTERNALLY ROTATED IMPLANTS. REP CAN PROVIDE THE PRIMARY AND REVISION USAGE, AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON. UPDATE 02/DECEMBER/2022 WG: REP SUPPLIED PRIMARY AND REVISION USAGE. A HEAD, LINER, AND SHELL WERE REVISED. SURGEON REPORTED HE WASN'T HAPPY WITH THE SHELL'S POSITION (NOT ENOUGH ANTEVERSION) AND DECIDED TO REVISE IT.

  Patient problems: Joint Dislocation

  MAUDE report 15940302 ↗
• InjurySep 9, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AS REPORTED: "PT. PRESENTED FOLLOWING MULTIPLE DISLOCATIONS OF THE LEFT HIP. DR. PLANNED TO CHANGE THE PT'S PRIMARY X3 INSERT AND BIOLOX HEAD TO AN MDM CONSTRUCT. UPON FURTHER INSPECTION OF THE ACETABULAR SHELL'S POSITION, HE OPTED TO CHANGE THE POSITION OF THE SHELL. THIS RESULTED IN A WASTED MDM METAL-LINER, BUT DR. CHOSE TO GO WITH A NEW TRIDENT II SHELL, X3 INSERT AND BIOLOX HEAD LIKE WHAT THE PT. ORIGINALLY HAD. NO COMPLAINTS FILED AGAINST THE IMPLANTS THEMSELVES, NO FURTHER INFO AVAILABLE."

  Patient problems: Joint Dislocation

  MAUDE report 15394040 ↗
• InjuryApr 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING CUP IMPACTION OF A RECENT THA CASE, WE RESULTED IN HAVING ACETABULAR FRACTURES. SURGICAL DELAY > 30 MINUTES. CASE TYPE / APPLICATION: THA. UPDATE 01/APRIL/2022: PER MPS: PLEASE PROVIDE DETAILS AS TO ALL MEASURES TAKEN TO ADDRESS THE ACETABULAR FRACTURES: PLATING THE POSTERIOR ACETABULUM WALL. FURTHER FRACTURES WERE NOT DISCOVERED UNTIL LATER ON. IT WAS REPORTED THE SHELL WAS PART OF THE FRACTURE EVENT IMPLANTED BUT REMOVED THE FOLLOWING DAY FOR A REVISION CUP. UPDATE: IT HAS BEEN REPORTED THAT IMPLANT MALPOSITION DID NOT CAUSE OR CONTRIBUTE TO THIS EVENT. IT HAS BEEN REPORTED TOO MUCH FORCE OR OVERSIZED CUP LEAD TO THIS. (PERIPROSTHETIC FRACTURE ONLY) IT HAS BEEN REPORTED THAT NO BONE PIN HOLES HAVE CAUSED OR CONTRIBUTED TO THIS EVENT. UPDATE 14/APRIL/2022: PER MPS: INTRA-OPERATIVELY ON (B)(6) 2022, A DISTAL FEMORAL FRACTURE HAD ALSO BEEN NOTICED VIA C-ARM. ON (B)(6) 2022, THE PATIENT WAS REVISED TO COMPETITOR ACETABULAR COMPONENTS, RESTORATION MODULAR PROXIMAL BODY, FEMORAL HEAD, AND THREE CABLE AND SLEEVE SETS.

  Patient problems: Bone Fracture(s)

  MAUDE report 14192092 ↗
• InjuryAug 12, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "DR...PERFORMED A LEFT HIP REVISION DUE TO ALTR. IMPLANTS ARE NOT AVAILABLE FOR RETURN DUE TO HOSPITAL POLICY. NO MORE INFORMATION IS AVAILABLE PER DOCTOR. LOT CODES ARE NOT KNOW SINCE ORIGINAL SURGERY WAS DONE AT A DIFFERENT FACILITY." SPOKE TO REP: CONFIRMED THAT THE ROBOT COULD NOT HAVE CONTRIBUTED TO THE ALTR. THERE ARE NO ALLEGATIONS AGAINST THE REVISED POLY LINER OR BIOLOX HEAD.

  Patient problems: Foreign Body Reaction

  MAUDE report 12314414 ↗
• InjuryAug 9, 2021Malposition of Device; Insufficient Device Problem Information; Malposition of Device; Insufficient Device Problem Information

  IT WAS REPORTED THAT FOLLOWING A PRIMARY TOTAL HIP AND A SUBSEQUENT PRIMARY REVISION, THE PATIENT REMAINED UNSATISFIED AND A SECOND REVISION WAS PERFORMED AGAIN (B)(6), 2021. THE TRIDENT CUP, MDM LINER, AND INSERT WERE REMOVED WITH AN EXPLANTATION DEVICE. UPDATE BASED ON MEDICAL REVIEW: REASON FOR REVISION WAS DUE TO MALPOSITION OF TRIDENT SHELL.

  Patient problems: Ambulation or Postural Difficulties; Insufficient Information

  MAUDE report 12298813 ↗
• InjuryFeb 24, 2020Malposition of Device; Malposition of Device

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO DISLOCATION OF THE FEMORAL HEAD FROM THE POLY LINER. THE HEAD AND LINER WERE REVISED, AND THE SHELL WAS REVISED IN ORDER TO CHANGE ITS POSITIONING. REP PROVIDED PRIMARY AND REVISION USAGE, AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE AVAILABLE.

  Patient problems: Injury; Joint Dislocation

  MAUDE report 9746813 ↗
• MalfunctionDec 26, 2019Device Difficult to Setup or Prepare; Difficult or Delayed Separation; Device Difficult to Setup or Prepare; Difficult or Delayed Separation

  SURGEON IMPLANTED A TRIDENT II TRITANIUM, 52MM CLUSTERHOLE CUP INTO A PATIENT. WHEN HE PROCEEDED TO UNSCREW THE TRIDENT II IMPACTOR, HE WAS UNABLE TO TURN THE WHEEL AND RELEASE THE IMPACTOR FROM THE CUP. HE HAD TO EXPLANT THE CUP AND REAM UP TO A 54 TRIDENT II CLUSTERHOLE CUP AND RE-IMPLANT WITH AN ORIGINAL TRIDENT IMPACTOR. HE COULD NOT DISENGAGE THE IMPACTOR FROM THE CUP. UPDATE: IF A MAGNETIC BOLT WAS INVOLVED,... NO SURGICAL DELAY OF APPROX 7-8 MINS.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 9519856 ↗
• InjuryJun 21, 2019Malposition of Device; Malposition of Device

  IT WAS REPORTED THAT THE PATIENT'S HIP WAS REVISED. A PRE-REVISION X-RAY SHOWED THE CUP SPUN WITH IT RIM FACING VERTICALLY UPWARDS. INTRA-OPERATIVELY, THE POLY INSERT WAS FOUND TO HAVE DISLOCATED FROM THE METAL MDM LINER. A STAGE 1 REVISION WAS PERFORMED DUE TO SUSPECTED INFECTION (IT IS UNKNOWN IF INFECTION WAS CLINICALLY CONFIRMED OR IDENTIFIED). AN ANTIBIOTIC SPACER WAS PLACED. REP PROVIDED A PICTURE OF THE EXPLANTS, AN IMPLANT REPORT, AND A PRE-REVISION X-RAY AND REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 8721886 ↗
• MalfunctionMay 23, 2019Malposition of Device; Malposition of Device

  SURGEON NOTIFIED REP THAT X-RAYS 6 MONTHS POST OP SHOW A SCREW PASSED COMPLETELY THROUGH THE ACETABULAR SHELL IN THE PATIENT'S RIGHT HIP. IT IS NOT KNOWN AT THE TIME OF REPORT IF THE SCREW WAS IMPLANTED THAT WAY. THE SURGEON HAS NOT REPORTED A PLAN TO REVISE THE PATIENT AT THE TIME OF REPORT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8637354 ↗
• MalfunctionMay 23, 2019Malposition of Device; Malposition of Device

  SURGEON NOTIFIED REP THAT X-RAYS 1 WEEK POST OP SHOW A SCREW PASSED COMPLETELY THROUGH THE ACETABULAR SHELL IN THE PATIENT'S RIGHT HIP. IT IS NOT KNOWN AT THE TIME OF REPORT IF THE SCREW WAS IMPLANTED THAT WAY. THE SURGEON HAS NOT REPORTED A PLAN TO REVISE THE PATIENT AT THE TIME OF REPORT. UPDATE (B)(6) 2019: MEDICAL REVIEW. CONFIRMED THE EVENT AND CONFIRMED MALPOSITION OF THE SCREW AS A ROOT CAUSE OF THE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8637348 ↗
• InjuryNov 6, 2017Material Deformation; Insufficient Device Problem Information; Material Deformation; Insufficient Device Problem Information

  THE PATIENT, A TRIDENT II TRITANIUM POST-MARKET CLINICAL STUDY SUBJECT, RETURNED TO CLINIC ON (B)(6) 2017 WITH A LOT OF DIFFICULTY WALKING AND PAIN. PT. FELT SHE GOT WORSE WHEN SHE STARTED GOING TO PT AND DEVELOPED MUSCLE SPASMS. ON EXAM, THERE WAS SIGNIFICANT LIMP, VERY TENDER TROCHANTER, PAIN ALONG THE SCIATIC NOTCH WITH A POSITIVE STRAIGHT LEG RAISE SIGN AND SLIGHTLY SHORTER ON THE LEFT COMPARED TO THE RIGHT LIMB LENGTH. PT WAS STOPPED AND SHE WAS GIVEN A MEDROL DOSE PAK. ON (B)(6) 2017 SHE RETURNED TO CLINIC AND DID NOT IMPROVE. SIGNIFICANT PAIN WITH RANGE OF MOVEMENT OF THE HIP, LOG ROLLING, INTERNAL AND EXTERNAL ROTATION, AND ABDUCTION. TENDERNESS OVER THE TROCHANTER. A CT SCAN WAS ORDERED AS WELL AS A CRP AND SED RATE. PT. RETURNED TO CLINIC (B)(6) 2017 FOR CT SCAN RESULTS. IT WAS FOUND THAT THE SUBJECT SUSTAINED AN ACETABULAR CRACK/FRACTURE.

  Patient problems: Bone Fracture(s); Injury; Loss of Range of Motion; Muscle Spasm(s); Pain

  MAUDE report 7002661 ↗