Tritanium 502-03-62GRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 07613327040180), received between Jan 3, 2019 and Nov 22, 2024 — classified as 7 injuries.

The most frequently reported specific device problem is “Malposition of Device” (2 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryNov 22, 2024Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO 'LOOSE ACETABULAR SOCKET.' ALSO REPORTED WERE 'CONTINUED PAIN AND MAINLY GROIN AND LATERAL PAIN' SHELL, SCREWS, LINER, AND FEMORAL HEAD WERE REVISED TO A COMPETITOR SHELL, SCREWS, AND LINER, AND A STRYKER LFIT HEAD.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 20755995 ↗
• InjuryJan 4, 2022Unintended Movement; Unintended Movement

  PATIENT REQUIRED A REVISION OF THEIR ACETABULAR COMPONENT. NO REVISION OF THE FEMORAL STEM WAS REQUIRED. THE SURGEON USED A FEMORAL HEAD ALLOGRAFT TO FILL A CENTRAL DEFECT, A WEDGE AUGMENT TO FILL A POSTERIOR DEFECT AND A COMPETITOR BUTTRESS AUGMENT FOR A SUPERIOR DEFECT. A TRIDENT MULTI HOLE CUP WAS INSERTED AND THE CONSTRUCT WAS TRIALED WITH MDM TRIALS. STABILITY AND LEG LENGTH WERE SATISFACTORY AND THE HEAD AND MDM INSERT WERE IMPLANTED. UPDATE: THERE WAS PROTRUSION OF THE ACETABULAR CUP INTO THE PELVIS.

  Patient problems: Insufficient Information

  MAUDE report 13150582 ↗
• InjuryNov 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD RIGHT INDEX THA (OUTSIDE OF CORS SCOPE ON (B)(6) 2007). PATIENT HAD A RIGHT THA REVISION FOR MECHANICAL LOOSENING OF THE ACETABULUM ON (B)(6), 2012. ALL COMPONENTS EXCHANGED EXCEPT FEMUR. PATIENT HAS HISTORY OF CANCER WITH METASTASIS TO PELVIS, WITH A REVISION OF LEFT THA (OUTSIDE OF CORS SCOPE). NOW THE PATIENT PRESENTS WITH METASTASIS ON RIGHT FEMUR AND PELVIS, UNDERGOES REVISION SURGERY ON (B)(6), 2021 WITH OFF-LABEL COMPONENTS. ALL COMPONENTS EXCHANGED.

  Patient problems: Cancer

  MAUDE report 12809034 ↗
• InjuryAug 30, 2021Unstable; Malposition of Device; Unstable; Malposition of Device

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO INSTABILITY. A 36 +10 FEMORAL HEAD, LINER, SHELL AND 3 SCREWS WERE REVISED (REP REPORTED THE SURGEON WANTED TO CHANGE THE POSITION OF THE SHELL) TO ANOTHER 36 +10 FEMORAL HEAD AND COMPETITOR ACETABULAR COMPONENTS. REP PROVIDED USAGE SHEETS FOR THE PRIMARY AND SUBSEQUENT REVISIONS (PRIOR REVISION REPORTED) AND AN X-RAY (TAKEN BETWEEN (B)(6) 2020 AND (B)(6) 2021). REP ALSO CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Insufficient Information; Joint Laxity

  MAUDE report 12384062 ↗
• InjuryNov 5, 2020Osseointegration Problem; Osseointegration Problem

  THE FOLLOWING WAS REPORTED: RIGHT MAKO HIP. CUP LOOSENED 3 DAYS POST OP. REVISION SURGERY FOR CUP, LINER AND HEAD. 3 SCREWS ADDED TO CUP. INITIAL SURGERY (B)(6) 2020.

  Patient problems: Inadequate Osseointegration

  MAUDE report 10790648 ↗
• InjuryMay 8, 2019Malposition of Device; Noise, Audible; Malposition of Device; Noise, Audible

  IT WAS REPORTED THAT PATIENT HAS EXPERIENCED AUDIBLE NOISE IN THEIR RIGHT HIP SINCE IMPLANTATION (NOISE REPORTED AS BEING SQUEAKY). AT FIRST THE NOISE WAS INTERMITTENT, BUT HAS INCREASED IN FREQUENCY AND HAS BECOME MORE PRONOUNCED IN THE LAST 6 MONTHS. THE SURGEON WANTS TO KNOW IF SIMILAR REPORTS HAVE BEEN RECEIVED FOR THESE DEVICES AS THE SURGEON CANNOT DETERMINE IF THE SQUEAKING ARISES FROM THE HEAD/TRUNNION INTERFACE OR THE SHELL/LINER INTERFACE. THE PATIENT HAS NOT YET BEEN REVISED, SURGEON WANTS TO WAIT FOR THE AFOREMENTIONED RESULTS BEFORE MAKING A DECISION. UPDATE BASED ON MEDICAL REVIEW 11 APRIL 2019: CUP MALPOSITION IN EXCESSIVE ANTEVERSION AS WELL AS SUPERFICIAL POSITION HAVE CONTRIBUTED TO IMPINGEMENT BETWEEN STEM NECK AND CUP SHELL POSTERIOR IN THE JOINT WITH SECONDARY DISPLACEMENT OF THE MDM POLY CAP ALLOWING METAL-METAL CONTACT BETWEEN DEVICES TO CAUSE A SQUEAKING NOISE FROM THE ARTHROPLASTY.

  Patient problems: No Information

  MAUDE report 8592576 ↗
• InjuryJan 3, 2019Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE PATIENT HAS PAIN THAT COMES AND GOES. UPDATE: REP REPORTED PATIENT WAS REVISED ON (B)(6) 2018: "PATIENT...MET SURGEON'S CRITERIA FOR REQUIRING REVISION ARTHROPLASTY FOR THE IMPLANTS LISTED". INTRAOPERATIVE, THE CUP WAS FOUND TO BE LOOSE AND EXCESSIVE CORROSION WAS NOTED ON THE TRUNNION.

  Patient problems: Inadequate Osseointegration; Injury; Pain

  MAUDE report 8214878 ↗