Tritanium 500-03-52DRecalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 07613327040043), received between Jun 3, 2016 and Sep 25, 2026 — classified as 12 injuries, 1 malfunction.

The most frequently reported specific device problem is “Loss of Osseointegration” (8 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjurySep 25, 2026Patient Device Interaction Problem

  The following information was provided: Incoming letter from the user: Can you provide a document containing the necessary information about the composition (in terms of metals) of the endoprosthesis? I am currently dealing with a systemic immune reaction to the prosthesis (which was implanted in May of this year). I am scheduled for a revision (replacement), so it is absolutely essential to determine which metal I am allergic to in order to select a prosthesis made of alloys that are suitable specifically for me. I would very much like to minimize the risk of becoming disabled.

  Patient problems: Foreign Body Reaction

  MAUDE report 50896025 ↗
• InjuryJul 31, 2026Loss 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 her left hip on or about (b)(6) 2015 and was revised on (b)(6) 2021. 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.Additional information based on a review by a clinician of the provided medical records states: 'This product inquiry concerns a patient who underwent a primary left total hip arthroplasty in 2015 and was revised in 2021 for a loose acetabular component and trunnionosis without pseudo-tumor.'

  Patient problems: Inadequate Osseointegration; Metal Related Pathology

  MAUDE report 50105189 ↗
• InjuryJul 28, 2026Loss of Osseointegration

  The following information was provided: 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 left hip on or about (b)(6)2016 and was revised on (b)(6)2021. It is further alleged that she suffered injuries as a result of implantation and explantation of the device at issue, and device recall. The revision Operative report states that the acetabular component was grossly loose and easily removed. It was revised to a larger shell. Upon removal of the femoral head corrosion with black material was noted on the trunnion.Additional info - Med review states 'The revision Operative report states that the acetabular component was grossly loose and easily removed. It was revised to a larger shell. Upon removal of the femoral head corrosion with black material was noted on the trunnion.'

  Patient problems: Inadequate Osseointegration

  MAUDE report 50057165 ↗
• InjuryJan 9, 2024Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THROUGH THE FILING OF A LAWSUIT THAT ALLEGEDLY THE PATIENT WAS IMPLANTED WITH AN LFIT ANATOMIC V40 FEMORAL HEAD ON HER LEFT HIP ON (B)(6) 2014. IT IS FURTHER ALLEGED THAT THE SUBJECT PRODUCTS MALFUNCTIONED AND/OR DISLODGED CAUSING INJURIES TO PATIENT, INCLUDING BUT NOT LIMITED TO ELEVATED COBALT LEVELS AND THE NEED FOR FURTHER SURGERY TO REPLACE THE STRYKER IMPLANTS. UPDATE: REVISION OPERATIVE REPORT INDICATES THAT THE PATIENT PRESENTED WITH RIGHT HIP PAIN AND A LOOSE ACETABULAR COMPONENT. WORK-UP REVEALED ELEVATED METAL ION LEVELS. PRE-OP ASPIRATION SHOWED STAPH EPIDERMIS INFECTION. INTRAOPERATIVELY, SOME SUPERIOR BONE LOSS WAS NOTED AROUND THE ACETABULUM. "CLEAR CORROSION" OF THE FEMORAL TRUNNION WAS OBSERVED FOLLOWING REMOVAL OF THE FEMORAL HEAD. FEMORAL AND ACETABULAR COMPONENTS WERE REVISED AND IRRIGATION AND EXCISIONAL DEBRIDEMENT WERE PERFORMED.

  Patient problems: Bacterial Infection; Inadequate Osseointegration; Metal Related Pathology; Pain

  MAUDE report 18480909 ↗
• InjuryFeb 7, 2023Loss of Osseointegration; Osseointegration Problem; Loss of Osseointegration; Osseointegration Problem

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO ASEPTIC LOOSENING OF THE ACETABULAR COMPONENT. A SHELL, HEAD, AND LINER WERE REVISED.

  Patient problems: Inadequate Osseointegration

  MAUDE report 16315859 ↗
• InjuryNov 7, 2022Unstable; Osseointegration Problem; Unstable; Osseointegration Problem

  PATIENT HAD A PRIMARY RIGHT HIP REPLACEMENT IN 2015 AND PATIENT REPORTED EXPERIENCING INSTABILITY AND PAIN. PATIENT REPORTED A "TRIDENT 1 TITANIUM CUP FIRST GENERATION FAILED TO HAVE BONE INGROWTH".

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 15749740 ↗
• InjuryJan 12, 2022Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED A STAGE 1 REVISION WAS PERFORMED ON THE PATIENT'S RIGHT HIP DUE TO INFECTION. INTRA-OPERATIVELY, SURGEON REPORTED THAT THE CUP 'SPUN OUT' AND THAT THERE WAS CORROSION AT THE STEM/ NECK JUNCTION OF THE MODULAR STEM. ALL COMPONENTS WERE REMOVED AND A SPACER WAS PLACED.

  Patient problems: Inadequate Osseointegration; Unspecified Infection

  MAUDE report 13236470 ↗
• InjuryMar 12, 2021Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED BY PATIENT'S COUNSEL THAT ALLEGEDLY THE PATIENT WAS IMPLANTED WITH A TRITANIUM ACETABULAR CUP ON (B)(6) 2016 AND WAS REVISED ON (B)(6) 2019 DUE TO ALLEGED CUP LOOSENING.

  Patient problems: Inadequate Osseointegration

  MAUDE report 11472620 ↗
• InjuryJun 28, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  DR. REPORTED THE FOLLOWING: THE PATIENT THAT RECEIVED A CONSTRAINED LINER ON THE (B)(6) (PER 2067592) LUXATED THE LINER FROM THE TRITANIUM CUP. DR. MENTIONED THAT THE PATIENT IS DIFFICULT TO INSTRUCT. THE PRIMARY SURGERY TOOK PLACE IN 2014 (EXETER STEM AND TRITANIUM SOLID CUP). THERE WAS AN ACETABULAR REVISION IN 2017. AN MDM LINER WAS PLACED. THIS WAS LUXATED. REVISION SURGERY IS SCHEDULED ON(B)(6) . UPDATE(B)(6) 2019 : THIS EVENT IS FOR THE 3RD REVISION SURGERY WHICH OCCURRED FOR THIS PATIENT ON (B)(6) 2019. REVISION WAS DUE TO DISASSOCIATION BETWEEN THE TRIDENT LINER AND SHELL. TWO PREVIOUS REVISIONS WHICH OCCURRED IN 2017 ON (B)(6) 2019 BOTH RELATE TO DISLOCATION. AN UNKNOWN EXETER STEM WAS ADDED TO THE PRODUCT GRID IN THIS COMPLAINT INVESTIGATION BASED ON THE MEDICAL REVIEW FOR LIMB LENGTH DISCREPANCY AND MIGRATION.

  Patient problems: Injury

  MAUDE report 8745747 ↗
• InjuryMay 17, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  DR. CONTACTED FOR A MDM LUXATED BY A PATIENT WITH A THA. THE PRIMARY SURGERY TOOK PLACE IN 2014 (EXETER STEM AND TRITANIUM SOLID CUP). THERE WAS AN ACETABULAR REVISION IN 2017. THE EXACT DATE IS UNKNOWN ADDITIONAL PATIENT RECORDS/ X-RAYS AND OPERATION REPORTS ARE NOT AVAILABLE IN THIS CASE THIS IS A PI RELATED TO PI 2067592 AND IS REPORTED FOR A PRIMARY REVISION THAT HAD TAKEN PLACE WITHIN THE SAME PATIENT. UPDATED BASED ON MEDICAL REVIEW. THIS PI RELATES TO FIRST REVISION SURGERY WHICH OCCURRED IN 2017 DUE TO DISLOCATION BETWEEN THE FEMORAL HEAD AND X3 LINER. THE MEDICAL REVIEW REVEALED. - CUP MALPOSITION WITH NON-ANATOMICAL ANTEVERSION AND INCLINATION - SHORT LEFT LEG WITH 1-CM CONTRIBUTING TO SOFT TISSUE LAXITY AROUND THE HIP - USE OF 22-MM FEMORAL HEAD HAS SMALL EFFECTIVE ROM AND THEREBY MINIMAL TOLERANCE AGAINST IMPINGEMENT AN UNKNOWN EXETER STEM WAS ADDED TO THE PRODUCT GRID IN THIS COMPLAINT INVESTIGATION BASED ON THE MEDICAL REVIEW FOR LIMB LENGTH DISCREPANCY AND MIGRATION.

  Patient problems: Injury

  MAUDE report 8619206 ↗
• MalfunctionNov 15, 2018Packaging Problem; Packaging Problem

  AFTER THE DEVICE WAS OPENED THE SURGEON NOTICED AN UNUSUAL MARK INSIDE THE SHELL AND WASN'T HAPPY TO USE THIS FOR THE PROCEDURE. ANOTHER IMPLANT WAS OPENED WITH NO ISSUES AND THE CASE WAS COMPLETED AS PLANNED. SURGICAL DELAY: 30 SECONDS TO RETRIEVE A REPLACEMENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8073792 ↗
• InjuryJul 2, 2018Loss of Osseointegration; Loss of Osseointegration

  REVISION TOTAL HIP FOR LOOSE ACETABULAR COMPONENT.

  Patient problems: Inadequate Osseointegration; Injury

  MAUDE report 7655800 ↗
• InjuryJun 3, 2016Failure to Osseointegrate; Loss of Osseointegration; Insufficient Device Problem Information; Failure to Osseointegrate; Loss of Osseointegration; Insufficient Device Problem Information

  PATIENT HAD A TOTAL HIP REVISION AT (B)(6) HOSPITAL IN (B)(6) BY DOCTOR DR. (B)(6) DUE TO LOOSENING AFTER EXPERIENCING PAIN AND GRINDING. PATIENT STATED SHE CURRENTLY HAS NO ISSUES WITH HER HIP.

  Patient problems: Inadequate Osseointegration; Injury; Pain

  MAUDE report 5698173 ↗