Trident 502-11-48DRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04546540432018), received between Mar 22, 2019 and Oct 30, 2024 — classified as 5 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryOct 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FRACTURE IN THE POSTERIOR SUPERIOR ACETABULUM DURING A MAKO THA 4.0. EVENT OCCURRED DURING IMPACTION. X3 SCREWS WHERE USED IN THE ACETABULUM AS A RESULT. PATIENT INFORMATION NOT AVAILABLE. MAKO THA 4.0 ROB2689.

  Patient problems: Bone Fracture(s)

  MAUDE report 20569775 ↗
• InjuryDec 15, 2023Adverse Event Without Identified Device or Use Problem; Osseointegration Problem; Adverse Event Without Identified Device or Use Problem; Osseointegration Problem

  PATIENT IS STATUS POST RIGHT TOTAL HIP REVISION COMPLETED TODAY DUE TO HIP PAIN/ POSSIBLE ASEPTIC LOOSENING. ALL COMPONENTS REMOVED TODAY EXCEPT FOR STEM. COMPETITOR UTILIZED FOR CUP, SCREWS, LINER.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 18340882 ↗
• InjuryApr 8, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED DUE TO SHELL LOOSENING. SURGEON REPORTED CAUSE OF LOOSENING WAS POOR PATIENT BONE QUALITY. THE SHELL, HEAD, AND LINER WERE REVISED. REP CONFIRMED THAT THERE WERE NO ALLEGATIONS AGAINST ANY OF THE REVISED DEVICES, PROVIDED PRIMARY AND REVISION USAGE REPORTS, AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED.

  Patient problems: Inadequate Osseointegration; Injury

  MAUDE report 9938408 ↗
• InjuryJun 18, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT HAD PRIMARY RIGHT TOTAL HIP COMPLETED ON (B)(6) 2019. PATIENT WAS SEEN PRIOR TO REVISION SURGERY FOR HIP DISLOCATION AND WAS CLOSE REDUCED. PATIENT DISLOCATED AGAIN AND WAS SCHEDULED FOR RIGHT REVISION SURGERY ON (B)(6) 2019. DURING DISSECTION PATIENT HAD A LARGE HEMATOMA THAT WAS DRAINED AND LAVAGED. THE PATIENT'S LEG WAS DISLOCATED AND ORIGINAL FEMORAL HEAD, CUP, SCREWS, AND ACETABULAR LINER WERE REMOVED. A NEW 50MM HEMI MULTIHOLE CUP WITH A NEW POSITION WAS INSERTED WITH THREE CORRESPONDING 6.5 X 25MM SCREWS. SURGEON THEN REQUESTED A 36D 0° LINER FOR TRIAL AND DECIDED ON A 36 +5 COCR V40 HEAD.

  Patient problems: Injury; Joint Dislocation

  MAUDE report 8707559 ↗
• InjuryMar 22, 2019Unstable; Unstable

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO INSTABILITY (POSSIBLE CAUSE OR CONTRIBUTOR FOR INSTABILITY NOT REPORTED TO REP). A SHELL, TWO SCREWS, AND A LINER WERE REVISED TO A TITANIUM REVISION SHELL AND MDM/ ADM LINER CONSTRUCT.

  Patient problems: Injury; Loss of Range of Motion

  MAUDE report 8443179 ↗