Trident 509-02-56ERecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 07613327025156), received between Apr 28, 2017 and Feb 18, 2021 — classified as 10 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (4 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 18, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE FOLLOWING WAS REPORTED: A REVISION OF THE PATIENT'S HIP DUE TO "DISLOCATION OF THE ACETABULAR CUP." THE REVISED DEVICES WERE REPORTED AS A SHELL (REFERRED TO AS "CUP"), MDM METAL LINER (REFERRED TO AS "MDM LINER", A BIOLOX CERAMIC HEAD, AND A RESTORATION MODULAR PROXIMAL BODY. PATIENT WAS REVISED TO COMPETITOR ACETABULAR COMPONENTS WITH A NEW BIOLOX HEAD AND RESTORATION MODULAR PROXIMAL BODY.

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 11344410 ↗
• InjuryJun 1, 2020Loss of Osseointegration; Loss of Osseointegration

  PATIENT REQUIRED A REVISION OF THE CUP TODAY DUE TO IT LOOSENING. THE ORIGINAL CASE WAS (B)(6) 2020; DUE TO PATIENT ANATOMY AT THAT TIME, THE SURGEON OPTED TO USE A TRIDENT TRITANIUM MULTIHOLE (509-02-56E). SURGEON REQUESTED SCREWS. TORX SCREWS WERE PROVIDED (2030-6516-1 AND 2030-6530-1). LINER WAS IMPACTED AND THE FEMUR WAS COMPLETED. I BECAME AWARE TODAY (5/8/2020) THAT THE PATIENT REQUIRED A REVISION OF THE CUP.

  Patient problems: Injury; Pain

  MAUDE report 10105425 ↗
• InjuryAug 8, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AS REPORTED: "PATIENT FELL. PATIENT CAME TO SURGERY [REVISION RIGHT HIP], MDM 42 HEAD WAS OFF THE COMPETITOR 28 +12 REVISION HEAD. MDM HEAD WAS IN PATIENT'S SOFT TISSUE. HEAD AND LINER REMOVED, TRIALED TO SEE WHAT NEW MDM CONSTRUCT WOULD BE STABLE. DOCTOR DECIDED TO REMOVE CUP AND SCREWS TO PUT MORE VERSION INTO A NEW CUP. PUT IN NEW 60 TITANIUM CUP, SCREWS, AND MDM LINER, USED A COMPETITOR HEAD WITH MDM HEAD WHICH IS OFF LABEL. CONSTRUCT WAS STABLE". UPDATE 18/JULY/2019: MDM HEAD CAME OUT OF LINER. YES THE LINER WAS FIXED AT TIME OF REVISION. PATIENT FELL AND THEY TRIED TO DO A CLOSED REDUCTION TO PUT CONSTRUCT BACK INTO ACETABULAR SHELL.

  Patient problems: Fall; Injury

  MAUDE report 8873361 ↗
• InjuryJul 24, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A STAGE 1 REVISION WAS PERFORMED ON THE PATIENT'S RIGHT HIP DUE TO INFECTION (INFECTION WAS CONFIRMED IN PATHOLOGY BUT THE INFECTING MICROORGANISM WAS NOT REPORTED TO THE REP). ALL COMPONENTS WERE REMOVED AND AN ANTIBIOTIC SPACER PLACED. REP WAS NOT PRESENT FOR THE PROCEDURE AND REPORTED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 8821680 ↗
• InjuryApr 16, 2019Loose or Intermittent Connection; Loose or Intermittent Connection

  THE PATIENT PRESENTED WITH ASEPTIC LOOSENING OF THE ACETABULAR CUP, WHICH WAS REVISED IN (B)(6) 2018. THE FEMORAL STEM WAS LEFT IN PLACE DURING THE FIRST REVISION. THE CUP LOOSENED AGAIN, REQUIRING A SECOND REVISION. WHEN WE EXPOSED THE COMPONENTS, WE NOTICED THAT THE MDM LINER/ACETABULAR SHELL WORE A NOTCH INTO THE NECK OF THE FEMORAL STEM. WE REMOVED ALL COMPONENTS AND INSERTED A RESTORATION MODULAR STEM, MULTIHOLE ACETABULAR CUP AND CONSTRAINED LINER.

  Patient problems: Injury

  MAUDE report 8518012 ↗
• InjuryJan 9, 2019Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO A LOOSE SHELL. A 56MM SHELL WITH 5 SCREWS, POLY LINER, BIOLOX CERAMIC HEAD AND SLEEVE WERE REVISED TO A 58MM TRITANIUM SHELL WITH 5 SCREWS, 10° ECCENTRIC LINER, AND A METAL HEAD (THERE WERE NO ALLEGATIONS AGAINST THE LINER, HEAD, OR SLEEVE). REP REPORTED THAT X-RAYS, MEDICAL RECORDS, AND ADDITIONAL INFORMATION ARE NOT AVAILABLE DUE TO HOSPITAL POLICY.

  Patient problems: Inadequate Osseointegration; Injury

  MAUDE report 8232016 ↗
• InjuryJul 3, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT'S RIGHT HIP WAS REVISED. AS REPORTED BY REP: "PATIENT WAS STANDING UP FROM A SEATED POSITION, HEARD A SOUND, AND FELT PAIN". UPDATE 11/JUN/2018: SPOKE TO REP. THE FEMORAL HEAD, POLY INSERT, AND METAL LINER DISASSOCIATED FROM THE SHELL. PATIENT WAS REVISED FROM A 56MM TO 68MM SHELL WITH 6 SCREWS, MDM/ ADM LINER CONSTRUCT, AND LFIT V40 +8 METAL HEAD.

  Patient problems: Injury; Pain

  MAUDE report 7659187 ↗
• InjuryMar 1, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT'S RIGHT HIP WAS REVISED DUE TO FAILED IMPLANT.

  Patient problems: Failure of Implant; Injury

  MAUDE report 7307252 ↗
• InjuryDec 27, 2017Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THAT PATIENT'S RIGHT HIP WAS REVISED AFTER PATIENT SUSTAINED AN ACETABULAR FRACTURE AND HAD A LOOSE SHELL. PATIENT WAS REVISED TO COMPETITOR'S SHELL AND LINER WITH AN ACCOLADE HEAD AND STEM.

  Patient problems: Bone Fracture(s); Injury

  MAUDE report 7148268 ↗
• InjuryApr 28, 2017Loss of Osseointegration; Malposition of Device; Device Dislodged or Dislocated; Positioning Problem; Loss of Osseointegration; Malposition of Device; Device Dislodged or Dislocated; Positioning Problem

  SURGEON REVISED A CUP, 2 SCREWS, HEAD, SLEEVE AND LINER WITH A LARGER, RE-POSITIONED CUP AND MDM LINER DUE TO DISLOCATION.

  Patient problems: Injury; Joint Dislocation

  MAUDE report 6529262 ↗