Trident 509-02-54ERecalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 07613327025149), received between Apr 18, 2017 and May 28, 2025 — classified as 16 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (5 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• InjuryMay 28, 2025Loss of Osseointegration; Malposition of Device; Osseointegration Problem; Loss of Osseointegration; Malposition of Device; Osseointegration Problem

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO THE TRUNNION OF THE RESTORATION MODULAR PROXIMAL BODY SHEARING OFF. INTRA-OPERATIVELY, IT WAS OBSERVED THAT THE SHELL HAD BEEN IMPINGING ON THE STEM - WEAR WAS NOTED ALONG THE RIM OF THE SHELL. THOUGH THE SHELL WAS ORIGINALLY THOUGHT TO BE WELL-FIXED, IT WAS FOUND INTRA-OPERATIVELY TO BE LOOSE. THE SHELL, MDM LINER, FEMORAL HEAD, AND RESTORATION MODULAR STEM CONSTRUCT WERE REVISED TO COMPETITOR IMPLANTS. IT WAS CONFIRMED THERE ARE NO ALLEGATIONS AGAINST THE REVISED HEAD OR LINER. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Inadequate Osseointegration

  MAUDE report 22096501 ↗
• InjuryOct 4, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  REVISED A RIGHT HIP CONSTRAINED LINER TO AN MDM DUE TO CONSTRAINED LINER DISENGAGING FROM THE CUP. ORIGINAL REVISION TO CUP AND MDM ON (B)(6) 2017. 2ND REVISION TO CONSTRAINED LINER WAS DONE AT THE SAME HOSPITAL AND SURGEON ON (B)(6) 2020. THE STEM NECK SHOWED WEAR FROM RUBBING ON THE CONSTRAINED LINER RIM.

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 20368263 ↗
• InjuryJul 22, 2022Osseointegration Problem; Osseointegration Problem

  SURGEON REVISED A LOOSE TRIATANIUM REVISION CUP WITH MDM LINER.

  Patient problems: Inadequate Osseointegration

  MAUDE report 15089521 ↗
• InjuryDec 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS PI IS FOR THE REVISION OF THE PATIENT'S HIP IN OR AFTER (B)(6) 2014 [REMOVAL OF PRIMARY IMPLANTS EXCEPT REJUVENATE MODULAR STEM AND NECK]. EVENT AS PER FORM: IN REPORTING A REVISION OF THE PATIENT'S HIP ON (B)(6) 2020, IT WAS DISCOVERED THAT THE PATIENT'S ORIGINAL SHELL, SCREWS, DOME HOLE PLUG, LINER, AND FEMORAL HEAD WERE REVISED TO ANOTHER FEMORAL HEAD AND COMPETITOR ACETABULAR COMPONENTS. REASON AND DATE OF THE REVISION ARE UNKNOWN BUT BASED ON THE RELEASE DATE OF THE IMPLANTED FEMORAL HEAD, SURGERY WOULD HAVE TAKEN PLACE IN OR AFTER (B)(6) 2014. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: No Information

  MAUDE report 10975435 ↗
• InjuryDec 3, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED DUE TO DISSOCIATION OF THE CONSTRAINED LINER (IMPLANTED (B)(6) 2019) FROM THE SHELL (IMPLANTED (B)(6) 2018). SURGEON REPORTED CONTRIBUTING PATIENT FACTOR OF DEMENTIA. THE CONSTRAINED LINER AND FEMORAL HEAD WERE REVISED TO THE SAME CATALOG NUMBERS. REP PROVIDED THE REVISION USAGE SHEET, AND CONFIRMED THERE ARE NO ALLEGATIONS AGAINST THE REVISED FEMORAL HEAD AND THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Joint Dislocation

  MAUDE report 10940652 ↗
• InjuryDec 2, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  DR REPORTS PATIENT A STATUS POST LEFT TOTAL HIP DONE ON (B)(6) 2020 HAD A FALL WHICH PUSHED THE CUP THROUGH THE MEDIAL WALL AND CAUSED A DISLOCATION. DR REQUESTED TO REVISE BOTH THE CUP AND FEMORAL SIDE. ALL IMPLANTS WERE REMOVED. A NEW TRITANIUM CUP MDM LINER RESTORATION MODULAR STEM AND HEAD WERE IMPLANTED PER SURGICAL TECHNIQUE. UPDATE, PER SALES REP: BECAUSE THE STEM HAD BEEN IN SITU FOR ONLY 2 WEEKS, THE SURGEON DECIDED TO REMOVE IT IN ORDER TO HAVE BETTER ACCESS TO THE ACETABULUM. REP CONFIRMED THERE ARE NO ALLEGATIONS AGAINST THE REVISED STEM.

  Patient problems: Bone Fracture(s); Fall

  MAUDE report 10934227 ↗
• InjuryNov 15, 2020Detachment of Device or Device Component; Positioning Problem; Detachment of Device or Device Component; Positioning Problem

  IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED DUE TO DISSOCIATION OF THE CONSTRAINED LINER FROM THE SHELL. SURGEON REPORTED THAT DUE TO IMPINGEMENT WITH THE STEM, THE LINER WAS LEVERED OUT OF THE SHELL. ALSO, THE SHELL WAS IN A NEUTRAL POSITION. A SHELL AND 2 SCREWS (IMPLANTED IN 2011), RESTORATION MODULAR PROXIMAL BODY (IMPLANTED IN 2013), LFIT FEMORAL HEAD AND CONSTRAINED LINER (BOTH IMPLANTED IN 2019) WERE REVISED. REP CONFIRMED THAT THERE ARE NO ALLEGATIONS AGAINST THE REVISED FEMORAL HEAD, AND THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON. CORRECTION 28/SEPTEMBER/2021 WG: IN REPORTING A 5TH REVISION ON 28/SEPTEMBER/2021 FOR THIS PATIENT'S LEFT HIP, REP CORRECTED INFORMATION FOR THE PATIENT'S PREVIOUS REVISION (THIS PI). A CONSTRAINED LINER AND FEMORAL HEAD WERE THE ONLY DEVICES REVISED.

  Patient problems: Ambulation or Postural Difficulties; Joint Laxity

  MAUDE report 10841559 ↗
• InjuryJan 24, 2020Fracture; Insufficient Device Problem Information; Fracture; Insufficient Device Problem Information

  PATIENT SLIPPED AND FELL. THE PATIENT SUSTAINED A FURTHER FRACTURED PELVIS AND RESULTED IN THE PATIENT REQUIRING ADDITIONAL SURGERY. THIS WAS TO REVISE THE PLATE AND CUP IN THE RIGHT HIP REPLACEMENT. THE IMPLANTS THAT HAD FORMED THE INITIAL PI 2019030 WERE EXPLANTED. THE 1/3RD TUBULAR PLATE THAT WAS INITIALLY IMPLANTED FOR THE POSTERIOR COLUMN FRACTURE WAS REVISED AND A MATTA PELVIC PLATE APPLIED. THE CUP WAS REMOVED ALONG WITH THE SCREWS. THE SHAFT OF THE 40MM GAP CUP SCREW ( ITEM 20800040 LOT PW17H7) WAS BROKEN WITH THE FALL. SCREW HEAD AND PART OF THE SHAFT CAME OUT; THE DISTAL PART OF THE SHAFT DR ELLIS ELECTED TO LEAVE IN SITU. THE FRACTURE OF THE SUPERIOR PELVIC RAMUS; THAT HAD BEEN OBSERVED DURING REVIEW OF THE POST-OP X-RAYS FROM THE INITIAL REVISION ON 18TH OF FEBRUARY WAS STILL VISIBLE. THE T-MARS (ZIMMER) REVISION CUP THAT WAS PUT IN TODAY, HAD A SCREW HOLE; WHICH WENT ALONG THE TRAJECTORY OF THE SUPERIOR PUBIC RAMUS. NO FURTHER FIXATION WAS APPLIED TO THIS FRACTURE; NO FURTHER PLATES OR SCREWS. NO FURTHER MEDICAL RECORDS ARE AVAILABLE DUE TO CONFIDENTIALITY. THE EXPLANTED IMPLANTS WERE DISCARDED BY THE NURSING STAFF AND UNABLE TO BE RETRIEVED.

  Patient problems: Hip Fracture; Injury

  MAUDE report 9625541 ↗
• InjuryApr 29, 2019Osseointegration Problem; Osseointegration Problem

  ITS REPORTED THE PATIENT UNDERWENT A RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2017 WHERE SHE WAS IMPLANTED WITH A STRYKER HIP SYSTEM. ITS FURTHER ALLEGED THAT THE PATIENT'S RIGHT HIP HAD TO BE REVISED ON (B)(6) 2018 DUE TO ACETABULAR COMPONENT LOOSENING.

  Patient problems: Inadequate Osseointegration; Injury

  MAUDE report 8561425 ↗
• InjuryMar 20, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  RIGHT HIP: DURING A REVISION ACETABULAR PROCEDURE A TRIDENT TRITANIUM SHELL WAS IMPLANTED. 5 SCREWS WERE USED FROM THE RESTORATION GAP PLATE SCREW CADDY, ALL PACKAGES WERE CHECKED BY SURGEON AND SCRUB NURSE. IN A POST-OP X-RAY IT WAS OBSERVED THAT A SCREW WAS DISASSOCIATED FROM THE CUP. WHEN USAGE STICKERS WERE CHECKED, IT WAS DISCOVERED THAT ONE OF THE SCREWS WAS A TORX CANCELLOUS BONE SCREW, NOT A RESTORATION GAP PLATE SCREW. UPDATE 21/FEBRUARY/2019: AS REPORTED IN ADVERSE CONSEQUENCE DETAILS "SURGEON SAID THAT HE HAD ATTEMPTED TO USE THE SCREW IN THE SUPERIOR PUBIC RAMUS TO LAG A FRACTURE. HE HAD DURING THE PROCEDURE PLATED THE POSTERIOR OF THE ACETABULUM. FX IN SUPERIOR PUBIC RAMUS WASN¿T DISCLOSED DURING SURGERY. POST SURGERY, THE PATIENT HAD ATTEMPTED TO WEIGHT BEAR AND REPORTED PAIN. X-RAY WAS TAKEN WHICH ALSO SHOWED A FRACTURE IN THE INFERIOR PUBIC RAMUS. SURGEON SAID HE IS UNSURE WHAT THE NEXT STEP WILL BE AT THIS STAGE." UPDATE 26-FEB-2019: "THE PROCEDURE WAS REMOVING WHAT WAS BELIEVED TO BE AN OLD COMPETITOR CUP. INITIALLY THE CASE WAS BOOKED AS ABG REMOVAL; HOWEVER THE CUP WAS DEFINITELY NOT AN ABG - I IDENTIFIED ON THE X-RAY THAT IT WASN¿T AN ABG AND THE ABG INSTRUMENT

  Patient problems: Bone Fracture(s); Pain

  MAUDE report 8438717 ↗
• InjuryJul 23, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AS REPORTED: "PATIENT PRESENTED TO ER WITH HIP PAIN. X-RAY REVEALED DISASSOCIATED CONSTRAINED LINER...REVISED WITH MDM LINER/ HEAD". REP REPORTED HE DOES NOT HAVE ACCESS TO ANY ADDITIONAL INFORMATION FROM SURGEON OR HOSPITAL.

  Patient problems: Injury

  MAUDE report 7712635 ↗
• InjuryJul 17, 2018Malposition of Device; Device Dislodged or Dislocated; Malposition of Device; Device Dislodged or Dislocated

  PATIENT PRESENTED TO E.R. X-RAY REVEALED DISASSOCIATED CONSTRAINED LINER AND LOOSE MALPOSITIONED CUP. SCHEDULED FOR REVISION SURGERY". REP CITED THAT THE PATIENT HAD SUFFERED MULTIPLE FALLS. REP ALSO REPORTED THAT X-RAYS, MEDICAL RECORDS, AND FURTHER INFORMATION WILL NOT BE RELEASED BY THE HOSPITAL.

  Patient problems: Fall; Injury

  MAUDE report 7695041 ↗
• InjuryJun 18, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  UPDATE PER MEDICAL REVIEW: "ON (B)(6) 2015 SHE UNDERWENT A RIGHT ACETABULAR LINER CHANGE AND ACHILLES ALLOGRAFT TO THE POSTERIOR CAPSULE FOR "UNSTABLE RIGHT THA"."

  Patient problems: Injury

  MAUDE report 7611390 ↗
• InjuryMay 17, 2018Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THAT PATIENT'S LEFT HIP WAS REVISED DUE TO LOOSENING OF THE ACETABULAR SHELL.

  Patient problems: Injury

  MAUDE report 7521400 ↗
• InjuryOct 31, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT HAS HAD PREVIOUS HIP SURGERIES, ONE PARTICULAR, IN (B)(6) WITH STYKER PRODUCTS. PATIENT COMPLAINED THAT THE IMPLANT MADE HER ILL. FINAL REPORT ON INDICATION FOR SURGERY IDENTIFIES THE FOLLOWING: RIGHT HIP. PATIENT FACTOR: EHLERS-DANLOS SYNDROME. DIFFICULTY WITH RANGE OF MOTION. IMPINGEMENT POSTERIORLY. INCREASING METAL IONS ON SERUM TESTING. WEAKNESS. REVISION RIGHT TOTAL HIP ARTHROPLASTY, ACETABULAR COMPONENT, FEMORAL COMPONENT.

  Patient problems: Inflammation; Injury; Loss of Range of Motion; Reaction

  MAUDE report 6990875 ↗
• InjuryApr 18, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED PATIENT'S ACETABULUM AND FEMUR WERE REVISED DUE TO PELVIC FRACTURE; LEFT HIP. CUP, MDM LINER, 28 + 8 V40 HEAD, 21+10 CONE BODY RESTORATION MODULAR STEM AND 5 SCREWS WERE REMOVED.

  Patient problems: Bone Fracture(s); Injury

  MAUDE report 6500662 ↗