TritaniumRecalls & reported problems across all models

We found 18 models of Tritanium by Howmedica Osteonics Corp. in the FDA's device registry (GUDID). Together they are named in 256 adverse event reports in the FDA's MAUDE database, received between Jun 3, 2016 and Sep 25, 2026 — classified as 247 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Loss of Osseointegration” (97 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Tritanium problems

Tritanium models

18 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Tritanium 502-03-50D

  Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate
  42 reports
• Tritanium 502-03-52D

  Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous cemented, osteophilic finish
  39 reports
• Tritanium 502-03-54E

  Prosthesis, hip, semi-constrained, metal/polymer, uncemented
  39 reports
• Tritanium 502-03-56E

  Prosthesis, hip, hemi-, femoral, metal
  39 reports
• Tritanium 502-03-58F

  Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate
  25 reports
• Tritanium 500-03-52D

  PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
  13 reports
• Tritanium 502-03-48C

  Prosthesis, hip, semi-constrained, metal/polymer, cemented
  10 reports
• Tritanium 502-03-60F

  Prosthesis, hip, semi-constrained, metal/polymer, cemented
  10 reports
• Tritanium 502-03-46B

  Prosthesis, hip, constrained, cemented or uncemented, metal/polymer
  7 reports
• Tritanium 502-03-62G

  Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate
  7 reports
• Tritanium 500-03-56E

  PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
  6 reports
• Tritanium 500-03-50D

  PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
  5 reports
• Tritanium 500-03-58F

  PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
  5 reports
• Tritanium 500-03-48C

  PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
  3 reports
• Tritanium 500-03-54E

  PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
  2 reports
• Tritanium 500-03-60F

  PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
  2 reports
• Tritanium 502-03-44A

  PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
  1 report
• Tritanium 502-03-64G

  PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
  1 report

Recent Tritanium adverse event reports

The 15 most recent reports across all models, 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 ↗
• InjuryOct 17, 2025Malposition of Device; Insufficient Device Problem Information; Malposition of Device; Insufficient Device Problem Information

  NO NEW INFORMATION.

  Patient problems: Pain

  MAUDE report 23322201 ↗
• 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 ↗
• InjuryJun 26, 2025Loss of Osseointegration; Loss of Osseointegration

  THE PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2020. ON (B)(6), 2025, THE REVISION SURGERY WAS PERFORMED BECAUSE OSTEOLYSIS WAS OBSERVED APPROXIMATELY ONE YEAR AFTER THE INITIAL SURGERY, AND THE PATIENT REPORTED PAIN DUE TO LOOSENING OF THE CUP. THE SURGEON HAS USED HA EXTENSIVELY IN THE PAST BUT USED THIS PRODUCT BECAUSE THE PATIENT IN THIS CASE WAS ALLERGIC TO SILVER.

  Patient problems: Inadequate Osseointegration; Osteolysis; Pain

  MAUDE report 22334907 ↗
• InjuryJun 3, 2025Loss of Osseointegration; Loss of Osseointegration

  THE SITE NOTIFIED STRYKER ON (B)(6) 2025 THAT DR. ASSESSED THIS SUBJECT'S CLINIC NOTES AND CONFIRMED THERE WAS A LOOSENING OF THE CUP. PERSISTENT NON-UNION FRACTURE (B)(6) 2017 OF THE POSTERIOR COLUMN WITH RADIOLUCENCY OF THE ACETABULUM.

  Patient problems: Inadequate Osseointegration

  MAUDE report 22131166 ↗
• 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 ↗
• InjuryApr 8, 2025Corroded; Adverse Event Without Identified Device or Use Problem; Corroded; Adverse Event Without Identified Device or Use Problem

  NO NEW INFORMATION.

  Patient problems: Insufficient Information; Metal Related Pathology

  MAUDE report 21795501 ↗
• 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 ↗
• 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 ↗
• InjuryNov 18, 2024Malposition of Device; Malposition of Device

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO SHELL MALPOSITION (IT WAS NOT REPORTED TO THE REP IF THE SHELL WAS IMPLANTED THAT WAY OR HAD MIGRATED). A SHELL, 2 SCREWS, LINER, AND HEAD WERE REVISED. REP CONFIRMED THERE WERE NO ALLEGATIONS AGAINST THE REVISED HEAD AND LINER, AND THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 20704205 ↗
• InjurySep 10, 2024Degraded; Degraded

  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 RIGHT HIP ON OR ABOUT (B)(6) 2011 AND WAS REVISED ON (B)(6) 2014. 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 COBALT AND CHROMIUM IN HER BLOOD. ADDITIONAL INFORMATION PER MEDICAL RECORDS RECEIVED: "EXPOSED SOME BURSAL TISSUE AND METALLIC FLUID ON THE SUPEROLATERAL ASPECT OF THE GREATER TROCHANTER, TRACKED DOWN INTO THE JOINT SPACE. I NOTICED A LARGE DEFECT IN THE SUPERIOR LATERAL ASPECT OF THE BASE OF THE NECK OF THE IMPLANT, INDICATING IMPINGEMENT." UPDATE PER MEDICAL REVIEW: THE CUP WAS NOTED AND THE PATIENT WAS DIAGNOSED WITH A LOOSE ACETABULAR COMPONENT. FINDINGS AT SURGERY INCLUDED RIGHT HIP EXTENSIVE METALLOSIS WITHIN THE JOINT SPACE THE FEMORAL COMPONENT WAS WELL FIXED THE ACETABULAR COMPONENT WAS GROSSLY LOOSE THE MDM METAL INSERT IMPINGED AGAINST THE STEM OF THE FEMUR AND HAD WORN AWAY APPROXIMATELY 20 TO 25% OF THE BASE OF THE NECK OF THE IMPLANT ON THE IT'S POSTERIOR SUPERIOR ASPECT.

  Patient problems: Foreign Body Reaction; Metal Related Pathology; Pain

  MAUDE report 20181833 ↗
• InjuryJul 24, 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 COCR V40 FEMORAL HEAD ON HIS RIGHT HIP ON OR ABOUT (B)(6) 2012 AND WAS REVISED ON (B)(6) 2017. IT IS FURTHER ALLEGED THAT HE SUFFERED INJURIES AS A RESULT OF IMPLANTATION AND EXPLANTATION OF THE DEVICE(S) AT ISSUE, DEVICE RECALL AND EXCESSIVE LEVELS OF CHROMIUM AND COBALT IN HIS BLOOD. THE ACETABULAR COMPONENT WAS GROSSLY LOOSE, ROTATED AND DEMONSTRATED NO BONY INGROWTH. THE ACETABULAR SCREW HAD FRACTURED APPROXIMATELY 5 MM INTO SUBCHONDRAL BONE. THE PATIENT'S TISSUE BELOW THAT FASCIAL LAYER SHOWED AN EXTREMELY ABUNDANT AGGRESSIVE PSEUDOCAPSULE FORMATION WITH NECROSIS OF THE TISSUE CONSISTENT WITH AN AGGRESSIVE TISSUE REACTION.

  Patient problems: Foreign Body Reaction; Inadequate Osseointegration; Metal Related Pathology; Necrosis

  MAUDE report 19823713 ↗
• InjuryMay 24, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PATIENT HAD A RIGHT HIP REVISION. THE CONSTRAINED LINER DISASSOCIATED FROM THE SHELL. CHANGED THE CONSTRAINED POLY AND HEAD. WENT UP TO +3 HEAD. POLY AND HEAD THAT CAME OUT WERE FINE/NO TRAUMA TO THEM.

  Patient problems: Joint Dislocation

  MAUDE report 19389557 ↗

Other Howmedica Osteonics Corp. products

• Triathlon608 models · 3,524 reports · 15 recalls
• Scorpio107 models · 113 reports · 28 recalls
• Trident160 models · 1,280 reports · 2 recalls
• Accolade57 models · 1,228 reports
• Duracon58 models · 65 reports · 16 recalls
• LFIT23 models · 852 reports
• TRIDENT II42 models · 188 reports · 12 recalls
• INSTRUMENT131 models · 290 reports · 7 recalls