Trident 502-11-54ERecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 04546540432049), received between Oct 10, 2017 and Jun 6, 2025 — classified as 7 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (3 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryJun 6, 2025Osseointegration Problem; Osseointegration Problem

  REVISION SURGERY WAS PERFORMED (B)(6) 2025 DUE TO LOOSENING OF THE IMPLANTED CUP. WHEN THE CUP WAS REMOVED AND REPLACED, THE NECK OF THE STEM INTERFERED, SO THE STEM WAS ALSO REMOVED.

  Patient problems: Inadequate Osseointegration

  MAUDE report 22158893 ↗
• InjuryOct 1, 2024Malposition of Device; Malposition of Device

  IT WAS REPORTED THROUGH THE FILING OF A LAWSUIT THAT ALLEGEDLY THE PATIENT WAS IMPLANTED WITH AN LFIT ANATOMIC COCR V40 FEMORAL HEAD ON HER RIGHT HIP ON OR ABOUT ON (B)(6) 2011 AND WAS REVISED ON (B)(6) 2018. IT IS FURTHER ALLEGED THAT SHE SUFFERED INJURIES AS A RESULT OF IMPLANTATION AND EXPLANTATION OF THE DEVICE AT ISSUE, DEVICE RECALL AND EXCESSIVE LEVELS OF CHROMIUM AND COBALT IN HER BLOOD. THE SURGEON FELT THE CUP WAS IN A SUBOPTIMAL VERTICAL POSITION. THE CUP WAS REVISED AND A NEW LINER PLACED. A SLEEVE AND NEW HEAD WERE IMPLANTED AS WELL.

  Patient problems: Foreign Body Reaction; Metal Related Pathology

  MAUDE report 20342880 ↗
• InjuryApr 11, 2022Loss of Osseointegration; Malposition of Device; Loss of Osseointegration; Malposition of Device

  TRIDENT CUP WAS LOOSE IN BONE, AND TURNED TO AN UNDESIRABLE POSITION.

  Patient problems: Inadequate Osseointegration

  MAUDE report 14071304 ↗
• InjuryOct 27, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AS REPORTED: "PATIENT REPORTED PAIN AND INSTABILITY IN HIS RIGHT HIP. ORIGINAL HIP REPLACEMENT WAS PERFORMED IN 2012 AT AN OUTSIDE FACILITY. IMAGING SHOWED A COMPLETE DISASSOCIATION FROM THE FEMORAL HEAD COMPONENT OFF THE TRUNNION OF THE FEMORAL STEM COMPONENT. DURING THE PROCEDURE ADVERSE LOCAL TISSUE REACTION WAS REPORTED BY THE SURGEON, AS WELL AS THE TRUNNION WEARING THROUGH THE POLYETHYLENE LINER OF THE HIP AND INTO THE ACETABULAR COMPONENT DAMAGING THE LOCKING MECHANISM. ALL 5 COMPONENTS IMPLANTED DURING THE INDEX PROCEDURE WERE STRYKER COMPONENTS, THEY WERE REMOVED FROM THE PATIENT AND REVISED WITH STRYKER COMPONENTS." SPOKE TO REP, WHO PROVIDED THE REVISION USAGE SHEET. NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Pain

  MAUDE report 10740632 ↗
• MalfunctionFeb 10, 2020No Apparent Adverse Event; Insufficient Device Problem Information; No Apparent Adverse Event; Insufficient Device Problem Information

  PATIENT CALLED STATING SHE HAD A LEFT HIP REPLACEMENT DONE ON OCTOBER 24, 2007 AND WANTS TO KNOW IF HER IMPLANTS ARE PART OF A RECALL. PATIENT IS ASYMPTOMATIC AT THE TIME OF THIS CALL.

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

  MAUDE report 9688799 ↗
• InjuryNov 18, 2018Loss of Osseointegration; Insufficient Device Problem Information; Loss of Osseointegration; Insufficient Device Problem Information

  PATIENT CALLED STATING SHE HAD A RIGHT HIP REPLACEMENT ON (B)(6) 2013. PATIENT WAS REVISED ON (B)(6) 2018 DUE TO BROKEN SCREWS. EVENT UPDATE PER MEDICAL REVIEW: ON (B)(6) 2018 A REVISION RIGHT TOTAL HIP ARTHROPLASTY, ACETABULAR COMPONENT AND FEMORAL HEAD, WAS PERFORMED FOR A DIAGNOSIS OF RIGHT THA WITH ACETABULAR LOOSENING. THE OPERATIVE REPORT DESCRIBES SPINAL ANESTHESIA AND USE OF THE PREVIOUS POSTEROLATERAL APPROACH. THE OPERATIVE REPORT NOTES, ¿FEMORAL COMPONENT STABLE, HEAD REMOVED GROSS LOOSENING ACETABULAR COMPONENT REMOVED WITH RELATIVE EASE SCREW BROKEN AND CAME OUT WITH ACETABULAR COMPONENT BONE DEFECT MEDIAL CANCELLOUS BONE GRAFT REAMED FOR A 60 TRIDENT TRITANIUM SHELL WITH FIVE SCREWS, A 36/10° X3 POLY INSERT, A 36/PLUS-2.5 BIOLOX HEAD¿.

  Patient problems: Inadequate Osseointegration; Injury

  MAUDE report 8082773 ↗
• InjuryNov 13, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT'S LEFT HIP WAS REVISED AFTER PATIENT COMPLAINT OF SEVERE PAIN. INTRAOPERATIVELY, CAPSULE WAS FOUND TO CONTAIN A LARGE AMOUNT OF BLACK TISSUE (REPORTED AS METALLOSIS) AND THE TRUNNION HAD WORN DOWN TO THE POINT WHERE THE HEAD DISASSOCIATED FROM THE STEM. DUE TO THE AMOUNT OF BLACK TISSUE FOUND, ALL DEVICES WERE EXPLANTED (THERE WERE NO ALLEGATIONS AGAINST THE SHELL). PATIENT WAS REVISED TO A RESTORATION MODULAR STEM WITH A CERAMIC HEAD AND ADM CUP. PRIMARY IMPLANT WAS PERFORMED IN ANOTHER STATE BY AN UNKNOWN SURGEON AT AN UNKNOWN FACILITY - REVISING SURGEON HAS NO ACCESS TO ANY RECORDS FROM THE PRIMARY SURGERY. UPDATE BASED ON MEDICAL REVIEW: CUP AND STEM WERE STILL STABLE ALTHOUGH WITH OSTEOLYSIS AROUND THE CUP.

  Patient problems: Edema; Inflammation; Injury; Osteolysis; Pain; Reaction

  MAUDE report 8065740 ↗
• MalfunctionMar 29, 2018Material Discolored; Flaked; Material Discolored; Flaked

  SURGEON IMPACTED HA CLUSTER HOLE CUP, REMOVED FOR REPOSITION AND UPON REMOVAL NOTICE DISCOLORATION AND "FLAKING" OF HA COATING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7383029 ↗
• InjuryOct 10, 2017Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT HAD HER FIRST REVISION OF PRIMARY IMPLANTS PERFORMED ON (B)(6) 2017 DUE TO A SUBSIDED STEM. HER SECOND REVISION WHICH WAS PERFORMED ON (B)(6) 2017 WAS DUE TO THE PATIENT EXPERIENCING THREE DISLOCATION SUBSEQUENT TO HER (B)(6) 2017 REVISION SURGERY. EXPLANTS FROM THE (B)(6) 2017 REVISION IDENTIFY COMPONENTS THAT WERE IMPLANTED IN THE PRIMARY CASE ((B)(6) 2017) AND IN THE REVISION OF THE PRIMARY ((B)(6) 2017).

  Patient problems: Injury; Joint Dislocation

  MAUDE report 6937343 ↗