Tritanium 502-03-56ERecalls & reported problems

Summary

The FDA's MAUDE database contains 39 adverse event reports that list this exact device (DI 07613327040166), received between Jan 18, 2017 and Aug 22, 2025 — classified as 37 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Loss of Osseointegration” (17 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 25 most recent of 39 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 22, 2025Inadequacy of Device Shape and/or Size; Material Integrity Problem; Inadequacy of Device Shape and/or Size; Material Integrity Problem

  "SURGEON FOLLOWED SURGICAL TECHNIQUE TO PREPARE FOR IMPLANTATION. WHEN ACETABULUM WAS REAMED TO THE APPROPRIATE SIZE AND IMPLANT WAS OPENED FOR IMPLANTATION, SURGEON COULDN'T GET THE IMPLANT TO STICK TO THE BONE. FELT LIKE THE MANUFACTURING FINISH OF THE PRODUCT WASN'T THE USUAL STANDARD. SURGEON USES THIS TYPE OF SHELL ALL THE TIME AND NEVER HAD THIS ISSUE BEFORE. SURGEON WANTS TO KNOW IF THERE HAS BEEN ANY REPORTED ISSUES WITH THIS SHELL SIZE AND LOT NUMBER.". "THE SURGEON STATED THE SURFACE IN CONTACT WITH BONE WAS THE ISSUE, REFERRING TO THE SURFACE ON THE OUTER DIAMETER OF THE IMPLANT. THIS COULD BE CONSIDERED THE COATING.".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22874706 ↗
• InjuryMay 1, 2025Loss of Osseointegration; Migration; Loss of Osseointegration; Migration

  IT WAS REPORTED THE PATIENT'S LEFT HIP WAS REVISED. PATIENT FELL AND COMPLAINED OF PAIN. X-RAYS SHOWED A BROKEN SCREW AND POSSIBLE SHELL MIGRATION. INTRA-OPERATIVELY, THE SHELL WAS NOTED TO BE NOT WELL FIXED. A SHELL, 2 SCREWS (NOTE: REP WAS UNABLE TO DETERMINE WHICH OF THE 2 SCREWS HAD BROKEN), HEAD AND LINER WERE REVISED TO A MULTI-HOLE SHELL, MDM METAL LINER, ADM/ MDM POLY INSERT, HEAD AND SLEEVE. REP CONFIRMED THERE WERE NO ALLEGATIONS AGAINST THE REVISED LINER OR HEAD. REP CONFIRMED THAT PICTURES CAN BE SENT. OTHERWISE, NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Fall; Inadequate Osseointegration; Pain

  MAUDE report 21941007 ↗
• InjuryJan 8, 2025Migration; Migration

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO PAIN AND SHELL MIGRATION. THE SHELL, LINER AND HEAD WERE REVISED. REP CONFIRMED THERE WERE NO ALLEGATIONS AGAINST THE REVISED LINER AND HEAD, AND THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Pain

  MAUDE report 21105300 ↗
• InjuryDec 22, 2023Loss of Osseointegration; Loss of Osseointegration

  PATIENT HAS PAIN ALL THE TIME BUT WORSE AFTER HE SITS AND STANDS. HE WALKS WITH AN ANTALGIC GAIT, AND HAS TO USE ROLLING SEATED WALKER FOR AMBULATION. HE HAS GROIN PAIN WITH INTERNAL ROTATION, EXTERNAL ROTATION, ABDUCTION AND ADDUCTION. IT IS ALLEGED THAT THE PATIENT HAS ACETABULAR COMPONENT LOOSENING AND NEEDS A REVISION.

  Patient problems: Ambulation or Postural Difficulties; Inadequate Osseointegration; Loss of Range of Motion; Pain

  MAUDE report 18382353 ↗
• InjuryNov 13, 2023Loss of Osseointegration; Loss of Osseointegration

  THE CUP WAS IMPLANTED IN THE PATIENT'S RIGHT HIP ON (B)(6) 2014. LOOSENING OF THE CUP WAS FOUND AND REVISION SURGERY TO CHANGE THE CUP WAS PERFORMED ON (B)(6) 2023.

  Patient problems: Inadequate Osseointegration

  MAUDE report 18118295 ↗
• InjuryOct 3, 2023Loss of Osseointegration; Osseointegration Problem; Loss of Osseointegration; Osseointegration Problem

  IT WAS REPORTED THAT THE PATIENT'S HIP WAS REVISED. AS REPORTED: "PATIENT WAS REVISED DUE TO PAIN AND SUSPECTED ACETABULAR COMPONENT LOOSENING. DURING SURGERY IT WAS NOTED THAT THE ACETABULAR COMPONENT WAS GROSSLY LOOSE. THERE WAS SOME PRESENCE OF CORROSIVE CHANGES ON THE TRUNNION AS WELL AS WITHIN THE FEMORAL HEAD. SURGEON ELECTED TO RETAIN THE FEMORAL COMPONENT AND PLACE A NEW ACETABULAR COMPONENT. A SLEEVED CERAMIC HEAD WAS IMPLANTED."

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 17866031 ↗
• InjuryAug 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT PRESENTING WITH PAIN AFTER ORIGINAL SURGERY SURGEON QUERIED INFECTION REPLACED TRITANIUM SHELL, HEAD AND LINER.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 17620876 ↗
• InjuryMay 31, 2023Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED TO PAIN AND SHELL LOOSENING. A SHELL, LINER, AND HEAD WERE REVISED.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 17029663 ↗
• InjuryJul 8, 2022Loss of Osseointegration; Osseointegration Problem; Loss of Osseointegration; Osseointegration Problem

  IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED DUE TO SHELL LOOSENING. THE SHELL, HEAD, AND LINER WERE REVISED. REP CONFIRMED THAT THERE ARE NO ALLEGATIONS AGAINST THE REVISED HEAD AND LINER.

  Patient problems: Inadequate Osseointegration

  MAUDE report 14961174 ↗
• InjuryApr 11, 2022Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO ASEPTIC LOOSENING OF THE ACETABULAR SHELL. THE SHELL, HEAD, AND LINER WERE REVISED. REP CONFIRMED THERE ARE NO ALLEGATIONS AGAINST THE REVISED HEAD AND LINER.

  Patient problems: Inadequate Osseointegration

  MAUDE report 14070977 ↗
• InjuryJan 5, 2022Malposition of Device; Adverse Event Without Identified Device or Use Problem; Malposition of Device; Adverse Event Without Identified Device or Use Problem

  PER MEDICAL RECORDS IN PI, REVISION OF LINER AND FEMORAL HEAD FOR DISLOCATION, SHELL AND SCREWS FOR REVISION FOR UNSPECIFIED REASON. UPDATE: - (B)(6) 2014 HEAD AND ACETABULAR REVISION DUE TO CHRONIC DISLOCATION.

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 13168665 ↗
• InjuryApr 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "PT. PRESENTED WITH A PAINFUL HIP REQUIRING REVISION OF A THA. SURGEON EXPLANTED ALL PREVIOUS COMPONENTS, PERFORMED A THOROUGH I&D." A NEW STRYKER HIP WAS IMPLANTED. SPOKE TO REP. THE PATIENT HAD BEEN EXPERIENCING WOUND DRAINAGE FOR YEARS. INTRA-OPERATIVELY, A 'BIO FILM' WAS OBSERVED BETWEEN THE SHELL AND THE PATIENT'S ACETABULUM, AND THE SURGEON SUSPECTED THIS MAY HAVE HARBORED BACTERIA AND SUSPECTED THE PATIENT HAD AN ACUTE INFECTION.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 11705302 ↗
• InjuryMar 15, 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) 2020 DUE TO ALLEGED CUP LOOSENING.

  Patient problems: Inadequate Osseointegration

  MAUDE report 11490384 ↗
• InjuryMar 10, 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)(4) 2017 AND WAS REVISED ON (B)(4) 2019 DUE TO ALLEGED CUP LOOSENING.

  Patient problems: Inadequate Osseointegration

  MAUDE report 11454448 ↗
• InjuryMar 10, 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) 2015 AND WAS REVISED ON (B)(6) 2020 DUE TO ALLEGED CUP LOOSENING.

  Patient problems: Inadequate Osseointegration

  MAUDE report 11454417 ↗
• InjuryNov 9, 2020Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO LOOSENING OF THE SHELL. THE SHELL, LINER, AND FEMORAL HEAD WERE REVISED. REP PROVIDED AN X-RAY AND PRIMARY USAGE, AND CONFIRMED THAT THERE ARE NO ALLEGATIONS AGAINST THE REVISED HEAD AND LINER, AND THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Inadequate Osseointegration

  MAUDE report 10808300 ↗
• InjuryApr 8, 2020Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO PAIN AND SHELL LOOSENING. THE SHELL, 2 SCREWS, LINER AND HEAD WERE REVISED TO A TRITANIUM SHELL WITH MDM LINER, ADM INSERT, AND A NEW HEAD. REP CONFIRMED THERE ARE NO ALLEGATIONS AGAINST THE REVISED HEAD AND LINER, AND THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Inadequate Osseointegration; Injury; Pain

  MAUDE report 9938734 ↗
• InjuryFeb 14, 2020Malposition of Device; Malposition of Device

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED. AS REPORTED BY REP: "NO TRAUMA TO PATIENT. PRIMARY WAS IMPLANTED APPROXIMATELY 5 YEARS AGO." A SHELL, ONE SCREW, LINER, AND HEAD WERE REVISED. UPDATE: "REVISED BECAUSE OF PAIN & MALPOSITIONED ACETABULAR CUP. HOSPITAL AND SURGEON APPROACHED-NO FURTHER INFORMATION WILL BE PROVIDED. EXPLANTS DISPOSED BY HOSPITAL".

  Patient problems: Injury; Pain

  MAUDE report 9711133 ↗
• InjuryDec 30, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THROUGH THE PATIENT THAT HE HAD A LEFT TOTAL HIP REPLACEMENT IN (B)(6) OF 2016. IT IS ALLEGED THAT A LITTLE OVER 90 DAYS HE DEVELOPED SIGNIFICANT LEVEL OF PAIN AND REDUCTION IN MOBILITY; INJECTIONS FOR INFLAMMATION, THERAPY, WORK RESTRICTIONS AND OTHER METHODS WERE TRIED TO ELIMINATE THE PAIN AND TO REGAIN LOST MOBILITY. IT IS FURTHER ALLEGED AFTER APPROXIMATELY 18 MONTHS THE CUP PORTION OF THE IMPLANT HAD FAILED AND HE WAS REVISED IN (B)(6) 2018.

  Patient problems: Ambulation or Postural Difficulties; Inflammation; Injury; Pain

  MAUDE report 9531985 ↗
• InjurySep 19, 2019Migration; Migration

  PATIENT IS PART OF THE TRITANIUM PRIMARY ACETABULAR SHELL STUDY AND REPORTED PAIN DURING THE 6-YEAR FOLLOW-UP VISIT. SUBJECT HAS MODERATE RIGHT HIP PAIN. PAIN IS GREATEST WHEN TRANSITIONING FROM STANDING TO A WALKING POSITION. SHE HAS BACK PAIN WITH PROLONGED STANDING. HER RIGHT HIP X-RAYS REVEALED SUBTLE RADIOLUCENCIES. THE SOCKET APPEARS TO BE STABLE. SUBJECT HAS A DIAGNOSIS OF LUMBAR SPONDYLOLISTHESIS AND HAS DEVELOPED MORE PELVIC ANTEVERSION THAN PREVIOUSLY. THERE HAS BEEN SOME MIGRATION OF THE RIGHT CUP POSITION, BUT IT APPEARS TO HAVE STABILIZED IN THE PAST COUPLE OF YEARS. PATIENT HAS NOT BEEN REVISED AS OF THE EVENT DATE.

  Patient problems: Pain

  MAUDE report 9087734 ↗
• InjuryAug 26, 2019Osseointegration Problem; Osseointegration Problem

  PATIENT HAD HIS HIP DONE A FEW YEARS AGO USING THE MAKO ROBOT, APPARENTLY DID WELL FOR AWHILE AND THEN HAD GROIN PAIN. UPDATE 31/JULY/2019 WG: SPOKE TO REP. INTRA-OPERATIVELY DURING THE REVISION, IT WAS OBSERVED THAT THERE WAS NO BONY ONGROWTH OF THE ACETABULAR SHELL. THE SHELL, 2 SCREWS, FEMORAL HEAD, AND LINER WERE REVISED. REP CONFIRMED THERE WERE NO ALLEGATIONS AGAINST THE HEAD OR LINER, AND THAT THERE WAS NO SURGICAL DELAY. REP PROVIDED PRE-REVISION X-RAYS AND A PICTURE OF THE EXPLANT, AND REPORTED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Inadequate Osseointegration; Injury; Pain

  MAUDE report 8932262 ↗
• InjuryJul 22, 2019Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED DUE TO LOOSENING OF THE SHELL. INTRA-OPERATIVELY, CORROSION WAS NOTED ON THE SCREWS. THE SHELL, 2 SCREWS AND POLY LINER WERE REVISED. REP REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Inadequate Osseointegration; Injury

  MAUDE report 8811272 ↗
• InjuryMar 4, 2019Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THROUGH A MEDWATCH " PATIENT IS A 51 YEAR OLD MALE WHO HAD A LEFT ANTERIOR HIP REPLACEMENT ON (B)(6) 2017 AND HAS CHRONIC L HIP PAIN SINCE THEN. HE HAS DEVELOPED ASEPTIC LOOSENING OF THE ACETABULAR COMPONENT. FILMS AND BONE SCAN CONSISTENT WITH LOOSENING. PLAN WAS TO PROCEED WITH REVISION OF ACETABULUM. PT TAKEN TO OR ON (B)(6) 2019 FOR "L HIP ISOLATED ACETABULAR REVISION. UPDATE (B)(6) 2019: IT WAS REPORTED THROUGH THE FILING OF A LAWSUIT THAT ALLEGEDLY THE PATIENT WAS IMPLANTED WITH A TRITANIUM ACETABULAR CUP IN HIS LEFT HIP ON (B)(6) 2017 AND BEGAN EXPERIENCING PAIN AND DISCOMFORT IN HIS HIP. IT WAS FURTHER ALLEGED DIAGNOSTIC WORKUP REVEALED DEVICE LOOSENING AND THE PATIENT WAS REVISED ON (B)(6) 2019. ALLEGEDLY DURING REVISION SURGERY "IT WAS DISCOVERED THAT THERE WAS NO INGROWTH OF BONE ON THE BACKSIDE OF THE ACETABULAR COMPONENT. THE OPERATIVE REPORT NOTES SOME FIBROUS INGROWTH. THE SURGEON REPORTED THAT THE CUP WAS LOOSE AND EASILY REMOVED".

  Patient problems: Inadequate Osseointegration; Injury; Pain

  MAUDE report 8386388 ↗
• InjuryFeb 12, 2019Osseointegration Problem; Osseointegration Problem

  SURGEON REVISED PATIENT'S ACETABULAR COMPONENT DUE TO LOOSENING OF THE IMPLANT. NO FURTHER INFORMATION WAS AVAILABLE". A LOOSE 56MM TRITANIUM HEMISPHERICAL CLUSTER HOLE SHELL, 6.5 X 25 BONE SCREW, 36MM 0° X3 INSERT, AND 36 -2.5 BIOLOX CERAMIC HEAD WERE REVISED.

  Patient problems: Inadequate Osseointegration; Injury

  MAUDE report 8333175 ↗
• InjuryFeb 6, 2019Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO ASEPTIC LOOSENING OF THE SHELL. A 56E TRITANIUM HEMISPHERICAL CLUSTER HOLE SHELL AND 36E POLY LINER WERE REVISED TO COMPETITOR DEVICES.

  Patient problems: Inadequate Osseointegration; Injury

  MAUDE report 8311608 ↗