Tritanium 502-03-46BRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 07613327040104), received between Oct 4, 2018 and May 25, 2021 — classified as 6 injuries, 1 malfunction.

The most frequently reported specific device problem is “Loss of Osseointegration” (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. 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryMay 25, 2021Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED DUE TO A LOOSE SHELL. A TRITANIUM 46MM HEMI CLUSTER HOLE SHELL AND ONE SCREW WERE REVISED. THERE ARE NO ALLEGATIONS AGAINST THE HEAD OR LINER. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Inadequate Osseointegration

  MAUDE report 11874811 ↗
• InjuryJun 18, 2020Loss of Osseointegration; Loss of Osseointegration

  AS REPORTED: "LEFT REVISION ANTERIOR THA ACETABULAR COMPONENT ONLY. DIAGNOSIS: FAILURE OF LEFT THA. SURGEON COMMENT: 'FIBROUS INGROWTH.'" REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Inadequate Osseointegration; Injury

  MAUDE report 10166674 ↗
• InjuryMay 1, 2020Loss of Osseointegration; Loss of Osseointegration

  THE REPLACEMENT WAS PERFORMED DUE TO THE LOOSENESS OF THE TRITANIUM CUP. OUR PRODUCTS ARE ONLY EXPLANTATION. ONE YEAR AFTER THE OPERATION, THE DOCTOR ASKED ME, "ISN'T BONE TISSUE INGROWN IN THE CUP?" HE WANTED AN INVESTIGATION REPORT INCLUDING THE CAUSE OF THE LOOSENING. REGARDING ACCOLADE II, IT WAS DIFFICULT TO REMOVE IT, SO HE ACKNOWLEDGED THE FIXATION, BUT HE ALSO WANTED A REPORT. UPDATE: LEFT SIDE. STEM WAS ALSO REMOVED AND REPLACED, AS THE CUP WAS LOOSE.

  Patient problems: Inadequate Osseointegration; Injury

  MAUDE report 10017025 ↗
• InjurySep 10, 2019Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED DUE TO SHELL LOOSENING. THE SURGEON ORIGINALLY THOUGHT THE SHELL WOULD BE REMOVED EASILY, BUT EFFORT WAS REQUIRED (REPORTED AS "NOT GROSSLY LOOSE, BUT NOT GROSSLY FIXED"). THE SHELL, 2 SCREWS, POLY LINER AND CERAMIC HEAD WERE REVISED. REP CONFIRMED THERE ARE NO ALLEGATIONS AGAINST THE LINER OR HEAD.

  Patient problems: Inadequate Osseointegration; Injury

  MAUDE report 8979675 ↗
• InjuryAug 14, 2019Osseointegration Problem; Osseointegration Problem

  REMOVED A 46MM TRITANIUM TRIDENT CUP. HE DID NOT USE OUR CUPS TO REPLACE THIS CUP. THE ORIGINAL SURGERY DATE WHEN THIS CUP WAS IMPLANTED WAS (B)(6) 2018. UPDATE FROM REP: "IT TOOK PLACE BECAUSE PATIENT PRESENTED WITH HIP PAIN. X-RAY SHOWS LUCENT LINES AROUND THE CUP OUTER RIM."

  Patient problems: Inadequate Osseointegration; Injury; Pain

  MAUDE report 8892338 ↗
• InjuryDec 28, 2018Malposition of Device; Osseointegration Problem; Malposition of Device; Osseointegration Problem

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED. AS REPORTED BY REP: "PREOPERATIVE DIAGNOSIS: RIGHT FAILED TOTAL HIP ARTHROPLASTY, COMPLICATION OF PROSTHETIC HIP "IMPLANT" [SURGEON] COMMENTED NO BONY INGROWTH TO CUP, ONLY FIBROUS". A SHELL, SCREW, INSERT, AND HEAD WERE REVISED.

  Patient problems: Congenital Defect/Deformity; Inadequate Osseointegration; Injury

  MAUDE report 8204499 ↗
• MalfunctionOct 4, 2018Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT DURING A TOTAL HIP ARTHROPLASTY (THA), A MIS-SEAL OF THE INNER BLISTER PACKAGE OF THE PRIMARY TRITANIUM HEMI CLUSTER HOLE CUP 46MM WAS FOUND. A SPARE WAS USED INSTEAD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7934369 ↗