Tritanium 502-03-60FRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 07613327040173), received between Jan 26, 2018 and Jan 13, 2023 — classified as 10 injuries.

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 16, 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.

• InjuryJan 13, 2023Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED BY THE PATIENT, THAT HE WAS IMPLANTED WITH A RIGHT STRYKER HIP ON (B)(6) 2018. THE PATIENT ALLEGES IN OR ABOUT (B)(6) 2018 HE STARTED TO EXPERIENCE EXCRUCIATING PAIN AND COULDN¿T PUT WEIGHT ON HIS HIP. THE PATIENT FOLLOWED UP WITH HIS PRIMARY SURGEON AND WAS DIAGNOSED WITH BURSITIS. THE PATIENT CONTINUED TO EXPERIENCE PAIN AND STATED HE HAS SEEN MULTIPLE DOCTORS. ALLEGEDLY IN 2021 THE PATIENT WENT FOR A SECOND OPINION AND THE SURGEON PERFORMED A RADIOLUCENCY TEST AND TOLD THE PATIENT THE ACETABULAR CUP WAS LOOSE AND REVISION SURGERY WAS RECOMMENDED. THE PATIENT WAS REVISED (B)(6) 2021. THE PATIENT IS SEEKING COMPENSATION FOR HIS PAIN AND SUFFERING.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 16156337 ↗
• InjuryJun 18, 2021Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THROUGH THE FILING OF A LAWSUIT THAT ALLEGEDLY THE PATIENT WAS IMPLANTED WITH AN LFIT ANATOMIC COCR V40 FEMORAL HEAD ON HIS LEFT HIP ON OR ABOUT (B)(6) 2011 AND WAS REVISED ON (B)(6) 2019. IT IS FURTHER ALLEGED THAT HE SUFFERED INJURIES AS A RESULT OF IMPLANTATION AND EXPLANTATION OF THE DEVICE AT ISSUE, DEVICE RECALL AND EXCESSIVE LEVELS OF CHROMIUM AND COBALT IN HIS BLOOD. UPDATE: HEAD DISASSOCIATION. UPDATE: METALLOSIS, LOOSE ACETABULAR COMPONENT.

  Patient problems: Ambulation or Postural Difficulties; Inadequate Osseointegration; Metal Related Pathology

  MAUDE report 12022792 ↗
• InjuryApr 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED DUE TO PAIN. A SHELL AND HEAD IMPLANTED (B)(6) 2018 AND A LINER IMPLANTED (B)(6) 2019 WERE REVISED TO A SHELL WITH 4 SCREWS, MDM METAL LINER, ADM/ MDM INSERT, AND CERAMIC HEAD WITH SLEEVE WERE IMPLANTED. REP PROVIDED IMPLANT INFORMATION FOR ALL SURGERIES AND THE PRIMARY OPERATIVE REPORT, AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Pain

  MAUDE report 11677498 ↗
• InjuryJan 14, 2021Loss of Osseointegration; Loss of Osseointegration

  AS REPORTED: "PATIENT'S LEFT ACETABULAR COMPONENTS WERE REVISED DUE TO LOOSENING. REVISED TO TRIDENT2 MULTI-HOLE SHELL." A SHELL, 3 SCREWS, POLY INSERT AND CERAMIC FEMORAL HEAD WERE REVISED.

  Patient problems: Inadequate Osseointegration

  MAUDE report 11172684 ↗
• InjuryJan 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED FROM A 60MM TRITANIUM HEMI CLUSTER SHELL, 6.5 X 40 MM BONE SCREW, TRIDENT 0° POLY INSERT, 36+0 CERAMIC V40 HEAD TO A 64 MM TRIDENT II MULTIHOLE SHELL, TRIDENT 10° POLY INSERT, AND LFIT V40 HEAD WITH THREE BONE SCREWS. SPOKE TO REP: ORIGINAL DIAGNOSIS WAS SHELL LOOSENING. HOWEVER, INTRA-OPERATIVELY THE SHELL WAS REPORTED AS WELL-FIXED AND DIFFICULT TO REMOVE. A SCREW WAS USED TO REMOVE THE SHELL. THERE ARE NO ALLEGATIONS AGAINST THE REVISED HEAD AND LINER. REP CONFIRMED THAT NO FURTHER INFORMATION WOULD BE RELEASED BY HOSPITAL OR SURGEON AND THAT EXPLANTS ARE NOT AVAILABLE FOR RETURN.

  Patient problems: No Information

  MAUDE report 11129720 ↗
• InjuryAug 20, 2020Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED DUE TO ASEPTIC LOOSENING OF THE SHELL AND TWO BROKEN SCREWS. INTRA-OPERATIVELY, WEAR WAS NOTED ON THE FEMORAL HEAD. THERE ARE NO ALLEGATIONS AGAINST THE REVISED LINER. PATIENT WAS REVISED TO A TRIDENT 2 SHELL, MDM METAL LINER, ADM/MDM POLY INSERT, AND A BIOLOX HEAD WITH SLEEVE.

  Patient problems: Injury

  MAUDE report 10435006 ↗
• InjuryNov 27, 2019Unstable; Unstable

  SECOND STAGE REVISION OF TRITANIUM PRIMARY CLUSTER CUP WITH ADM & EXETER. ALL COMPONENTS REVISED DUE TO INSTABILITY & HEAD/ADM INSERT DISASSOCIATION. I FILED ANOTHER PI ON HIS SAME PATIENT ONE WEEK AGO WHEN IT WAS DISCOVERED THIS PATIENT HAD ALREADY BEEN REVISED ON THE (B)(6) 2019, AGAIN DUE TO DISASSOCIATION OF HEAD WITH ADM INSERT. UPDATE (B)(6) 2019 WG: SALES REP REPORTED THAT THE TRITANIUM PRIMARY SHELL AND EXETER STEM WERE ALSO REVISED.

  Patient problems: Ambulation or Postural Difficulties; Injury

  MAUDE report 9383075 ↗
• InjuryOct 17, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  HEAD DISASSOCIATION REVISION, TRUNNIONS, INFECTED HIP WITH PLACEMENT OF STEM AND ALL POLY CUP. ON (B)(6) 2018: EXPLANT PHOTOS SHOW TRUNNION DAMAGE AND POLY WEAR.

  Patient problems: Injury; Reaction; Unspecified Infection

  MAUDE report 7976389 ↗
• InjuryOct 2, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT'S LEFT HIP WAS REVISED DUE TO PAIN AND PSEUDO-TUMOR. SHELL, SCREW, LINER, AND HEAD WERE REVISED TO A TRITANIUM REVISION SHELL, LINER, CERAMIC HEAD AND SLEEVE. THE STEM WAS NOT REVISED AND DID NOT APPEAR TO HAVE NOTABLE WEAR.

  Patient problems: Edema; Injury; Pain

  MAUDE report 7927934 ↗
• InjuryJan 26, 2018Malposition of Device; Positioning Problem; Malposition of Device; Positioning Problem

  IT WAS REPORTED THAT PATIENT'S LEFT HIP WAS REVISED DUE TO DISLOCATING SEVERAL TIMES. PATIENT WAS REVISED TO AN MDM CONSTRUCT. UPDATE (B)(6) 2018: A REVIEW BY A CLINICAL CONSULTANT HAS IDENTIFIED TRITAMIUM SHELL MALPOSITION AS CONTRIBUTING TO THE DISLOCATION EVENT.

  Patient problems: Injury; Joint Dislocation

  MAUDE report 7221393 ↗