Trilogy® Longevity® 6305-56-36 (REF 00-6305-056-36)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00889024123816), received between Nov 16, 2020 and Mar 4, 2024 — classified as 5 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryMar 4, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL LEFT TOTAL HIP ARTHROPLASTY. ONE YEAR POST IMPLANTATION, THE HEAD AND STEM WERE REVISED DUE TO LOOSENING OF THE FEMORAL COMPONENT WITH FAILURE TO OSSEOINTEGRATE. THE PATIENT WAS REVISED FOR A SECOND TIME, FIVE YEARS POST IMPLANTATION DUE TO FRACTURE OF THE REVISION STEM WITH COMPLICATED EXTRACTION VIA EXTENDED TROCHANTERIC OSTEOTOMY. AFTER THE SECOND REVISION, THE PATIENT EXPERIENCED RECURRENT DISLOCATIONS REQUIRING CLOSED REDUCTION UNDER ANESTHESIA. A THIRD REVISION WAS PLANNED BUT DELAYED DUE TO DIFFICULTY EXTUBATING THE PATIENT AND THE CONCURRENT ONSET BILATERAL PULMONARY EMBOLISMS. AFTER THE PATIENT¿S PULMONARY FUNCTION AND ANTICOAGULATION MEASURES WERE STABILIZED, THE REVISION OCCURRED DURING WHICH, MULTIPLE HEMATOMAS WERE EVACUATED FROM THE JOINT, AND POSTERIOR INSTABILITY WAS CONFIRMED ON EXAM. UPON REPLACING THE ACETABULAR SHELL, ANTEVERSION WAS INCREASED BY 15 DEGREES. A NEW CONSTRAINED HEAD AND LINER WERE PLACED WITHIN THE SHELL, AND THE REVISION STEM WAS RETAINED. POSTOPERATIVELY, THE PATIENT DEMONSTRATED SLOW BUT STEADY PROGRESS WITH INTENSIVE PHYSICAL THERAPY.

  Patient problems: Hematoma; Joint Dislocation; Pain; Pulmonary Embolism; Respiratory Failure

  MAUDE report 18825307 ↗
• MalfunctionNov 15, 2023Difficult to Insert; Off-Label Use; Difficult to Insert; Off-Label Use

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE IMPACTOR HANDLE BROKE AND THE SURGEON DECIDED TO USE WHAT WAS LEFT OF THE HANDLE TO COMPLETE THE PROCEDURE. WHILE IMPACTING WITH THE BROKEN HANDLE, THE LOCKING RING BECAME DISLODGED AND WAS UNABLE TO BE REINSERTED. AS A RESULT, THE LINER WAS CEMENTED INTO THE SHELL. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18141442 ↗
• InjuryJul 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL RIGHT TOTAL HIP ARTHROPLASTY REVISION. AFTER THE REVISION, THE PATIENT DID VERY WELL THEN PRESENTED WITH SUDDEN ONSET SWELLING ALONG THE DISTAL INCISION. AS THERE WERE NO CLINICAL INDICATIONS OF INFECTION, THIS WAS THOUGHT TO BE A SEROMA, AND THE PATIENT WAS SCHEDULED FOR AN INCISION AND DRAINAGE PROCEDURE. DURING THE PROCEDURE APPROXIMATELY 1-MONTH POST-REVISION, THE AREA OF THE SEROMA HAD A SLIGHT BROWN TINGE IN THE FLUID, BUT NO GROSS PURULENCE NOTED. THE SOFT TISSUES WERE THEN DEBRIDED WHICH REVEALED DEFECTS IN THE ILIOTIBIAL BAND WITH HETEROTOPIC OSSIFICATION AND GRANULATION TISSUE. AN EXTENSIVE IRRIGATION AND DEBRIDEMENT WAS PERFORMED WITH PLACEMENT OF ANTIBIOTIC BEADS. THE STEM AND SHELL WERE LEFT IN PLACE. ALL OTHER COMPONENTS WERE REVISED WITHOUT COMPLICATION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Extraskeletal ossification; Muscle/Tendon Damage; Seroma; Subclinical Infection

  MAUDE report 17344646 ↗
• InjuryMar 9, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

  Patient problems: Joint Dislocation

  MAUDE report 16511335 ↗
• InjurySep 1, 2021Unstable; Unstable

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Failure of Implant

  MAUDE report 12405014 ↗
• InjuryNov 16, 2020Unstable; Device Dislodged or Dislocated; Unstable; Device Dislodged or Dislocated

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Joint Dislocation

  MAUDE report 10844666 ↗