Tritanium 502-03-50DRecalls & reported problems

Summary

The FDA's MAUDE database contains 42 adverse event reports that list this exact device (DI 07613327040135), received between Oct 27, 2017 and Nov 18, 2024 — classified as 40 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Loss of Osseointegration” (18 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 42 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• InjuryMay 7, 2024Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THROUGH THE FILING OF A LAWSUIT THAT ALLEGEDLY THE PATIENT WAS IMPLANTED WITH AN LFIT V40 FEMORAL HEAD ON HER RIGHT HIP ON OR ABOUT (B)(6) 2009. IT IS FURTHER ALLEGED THAT SHE DEVELOPED BONE RESORPTION AT HER ACETABULUM AND PROXIMAL FEMUR AS WELL AS ELEVATED COBALT LEVELS IN HER BLOOD AND BASED UPON THESE FINDINGS SHE WAS REVISED ON (B)(6) 2018.

  Patient problems: Inadequate Osseointegration; Metal Related Pathology

  MAUDE report 19264255 ↗
• InjuryJan 12, 2024Positioning Problem; Positioning Problem

  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) 2022. 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. UPDATE: PER MEDICAL RECORDS RECEIVED, PATIENT ALSO EXHIBITED ALTR. CORROSION WAS OBSERVED AT THE STEM-HEAD INTERFACE INTRAOPERATIVELY. THE TRUNNION WAS WIPED CLEAN AND THE STEM WAS LEFT IMPLANTED AS IT WAS WELL-FIXED. THE SHELL WAS ALSO REVISED AS THE SURGEON FELT THE PATIENT "WOULD BENEFIT FROM REVISION TO A LARGER CUP WHICH IS MORE ANTEVERTED LESS VERTICAL."

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

  MAUDE report 18500317 ↗
• InjuryJan 31, 2023Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED BY THE PATIENT'S ATTORNEY AS A RESULT OF A LEGAL CLAIM THAT ALLEGEDLY THE PATIENT HAD A LEFT TOTAL HIP ARTHROPLASTY ON AUGUST 14, 2014. IT IS FURTHER ALLEGED THAT GRADUALLY OVER THE LAST 1 TO 2 YEAR SHE DEVELOPED LEFT GROIN PAIN. "RADIOGRAPH STUDIES AND CAT SCAN ARE CONSISTENT WITH DIAGNOSIS OF ASEPTIC LOOSENING OF A STRYKER TITANIUM CUP WITH A SINGLE SCREW." DURING REVISION SURGERY ON (B)(6) 2020 FINDINGS, "LEFT HIP CLEARLY JOINT EFFUSION. FEMORAL COMPONENT GOOD FIXATION WELL FIXED. NO SYNOVITIS. ACETABULAR COMPONENT WITH OVERGROWN BONE CIRCUMFERENTIAL AROUND THE PERIPHERY BUT NOTED TO BE GROSSLY LOOSE. HAD SOME FIBROUS FIXATION."

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 16270115 ↗
• InjuryJan 13, 2022Loss of Osseointegration; Loss of Osseointegration

  THE CUP IS GRADUALLY LOOSENING AND MOVING. THE PATIENT HAD A LITTLE PAIN AT THE BEGINNING OF THE MOVEMENT, BUT THE PAIN DISAPPEARED AS SHE WALKED. REVISION DUE TO CUP LOOSENING. PRIMARY SURGERY ON 2012.

  Patient problems: Pain

  MAUDE report 13248750 ↗
• InjuryMar 29, 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 DUE TO SHELL LOOSENING AND MIGRATION, AND A BROKEN SCREW. THERE WAS NO KNOWN CAUSE OR CONTRIBUTOR FOR THE LOOSENING OR MIGRATION. THERE ARE NO ALLEGATIONS AGAINST ANY OTHER IMPLANTS. A 50D CLUSTER HOLE SHELL AND TORX BONE SCREW WERE REVISED TO A 58F TRITANIUM SHELL WITH HEX SCREWS. REP CONFIRMED THAT NO FURTHER INFORMATION WOULD BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Inadequate Osseointegration

  MAUDE report 11580678 ↗
• InjuryMar 16, 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) 2019 DUE TO ALLEGED CUP LOOSENING.

  Patient problems: Inadequate Osseointegration

  MAUDE report 11494724 ↗
• InjuryMar 16, 2021Loss of Osseointegration; Loss of Osseointegration

  REVISED TRITANIUM CUP DUE TO LOOSENING.

  Patient problems: Inadequate Osseointegration

  MAUDE report 11494345 ↗
• InjuryMar 16, 2021Loss of Osseointegration; Loss of Osseointegration

  PATIENT PRESENTED IN OFFICE WITH PAIN. XRAYS REVEALED A LOOSE ACETABULAR COMPONENT. UPDATE: "ACETABULAR SHELL WAS LOOSE."

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 11493086 ↗
• 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) 2017 AND WAS REVISED ON (B)(6) 2020 DUE TO ALLEGED CUP LOOSENING.

  Patient problems: Inadequate Osseointegration

  MAUDE report 11472434 ↗
• InjurySep 15, 2020Loss of Osseointegration; Migration; Loss of Osseointegration; Migration

  NECROSIS OF THE LEFT FEMORAL HEAD. FIRST SURGERY ON (B)(6) 2013. THA. TRITANIUM CUP WAS IMPLANTED. IT CAUSED LOOSENING AND MIGRATION. IT WAS REPLACED ON (B)(6) 2020.

  Patient problems: Inadequate Osseointegration

  MAUDE report 10536045 ↗
• InjuryJul 3, 2020Unstable; Unstable

  CUP REVISED DUE TO PATIENT REPORTED PAIN. SURGEON REVISED FEMORAL HEAD TO 36MM+4 & REVISED CUP TO A ZIMMER CUP WITH SCREWS & 36MM POLY LINER. UPDATE 01/07/2020: INSTABILITY IS PROBABLE REASON FOR REVISION.

  Patient problems: Injury; Joint Laxity; Pain

  MAUDE report 10229119 ↗
• InjuryApr 8, 2020Migration; Migration

  AS REPORTED: "CUP SPUN OUT OF FIXATED LOCATION. ACTION TAKEN WAS EXPLANT AND REPLACED WITH REVISION CUP."

  Patient problems: Inadequate Osseointegration; Injury

  MAUDE report 9933776 ↗
• InjuryMar 30, 2020Malposition of Device; Malposition of Device

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO DISLOCATION OF THE CERAMIC HEAD AND POLY LINER, AND FOR SHELL MALPOSITION. THE PATIENT'S SHELL, HEAD, AND LINER WERE REVISED. REP CAN PROVIDE ADDITIONAL IMAGES,AND REPORTED THAT NO FURTHER INFORMATION WILL BE AVAILABLE.

  Patient problems: Injury; Joint Dislocation

  MAUDE report 9897821 ↗
• InjuryMar 24, 2020Failure to Osseointegrate; Failure to Osseointegrate

  AS REPORTED: "PATIENT WAS HARD TO REACH AFTER 1 YEAR VISIT SINCE SHE MOVED. HAD TRIED SEVERAL TIMES TO CONTACT HER AND GET HER TO COME IN FOR A FOLLOW UP VISIT AND SHE WAS UNREACHABLE. FINALLY GOT HOLD OF HER TODAY 2/26/2020 AND SHE INFORMED SHE HAD A TOTAL HIP REVISION ON HER RIGHT HIP IN 2018." "PER PATIENT, REVISION WAS RESULT OF PAIN IN HIP." MEDICAL REVIEW: "REVIEW OF THESE RECORDS CONFIRM THAT IN 2018 THE PATIENT HAD A REVISION OF A PRESS FIT HIP THAT HAD BEEN IMPLANTED IN 2014. AT HER ONE YEAR FOLLOW UP VISIT THE SURGEON FELT THAT THE GLOBAL HIP PAIN SHE WAS EXPERIENCING WAS CAUSED BY LACK OF SOLID BONY FIXATION OF HER CUP. IT IS LIKELY THE REVISION FOR PAIN WAS RELATED TO FIBROUS RATHER THAN BONY FIXATION OF HER ACETABULAR COMPONENT."

  Patient problems: Inadequate Osseointegration; Injury; Pain

  MAUDE report 9873507 ↗
• InjuryFeb 11, 2020Loss of Osseointegration; Loss of Osseointegration

  TRITANIUM PRIMARY CLUSTER CUP REVISED FOR LOOSENING ON (B)(6) 2020. THOUGH FOUR SCREWS WERE LISTED IN THE ORIGINAL USAGE REPORT, IT WAS NOT NOTED WHICH WERE WASTED. TWO SCREWS WERE IN THE PATIENT AT TIME OF REVISION--BOTH REMOVED, ONE BROKEN. RESTORATION MODULAR BODY WAS ALSO EXCHANGED AT TIME OF REVISION. PATIENT'S RIGHT HIP WAS REVISED TO COMPETITOR (ACETABULAR) AND STRYKER (FEMORAL) DEVICES. UPDATE PER RESPONSE: "NO ALLEGATIONS WERE MADE AGAINST ANY IMPLANTS OTHER THAN THE CUP."

  Patient problems: Inadequate Osseointegration; Injury

  MAUDE report 9696462 ↗
• InjuryDec 18, 2019Migration; Migration

  IN 2014, THA WAS PERFORMED. MIGRATION IS FOUND.

  Patient problems: Injury

  MAUDE report 9489047 ↗
• InjuryDec 16, 2019Loss of Osseointegration; Loss of Osseointegration

  THE PATIENT COMPLAINED ABOUT HER HIP PAIN. AFTER AN X-RAY, IT WAS DETERMINED THAT THE CUP WAS LOOSE. UPON EXPLANTATION, IT WAS DISCOVERED THAT THERE WAS NO BONY-INGROWTH ON THE CUP'S SURFACE. UPDATE: "THERE WERE NO ALLEGATIONS AGAINST THE LINER OR BIOLOX HEAD. THEY WERE REPLACED IN THE REVISION SURGERY, BUT THEY WORKED AS INTENDED FROM THE INDEX SURGERY."

  Patient problems: Inadequate Osseointegration; Injury; Pain

  MAUDE report 9477338 ↗
• MalfunctionNov 20, 2019Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  PRIMARY PROCEDURE, RIGHT HIP. IT WAS REPORTED THAT THE MAGNETIC BOLT COULD NOT THREAD INTO THE SHELL. A SECOND MAGNETIC BOLT, AND THEN AN OLDER DA IMPACTOR, WERE TRIED WITH THE SAME RESULT. AT THE BACK TABLE, WHEN THE DEVICES WERE SEPARATED, A CIRCULAR PIECE OF METAL FELL ONTO THE TABLE. THE SURGEON REAMED TO A LARGER SIZE AND IMPLANTED A LARGER SHELL USING ONE OF THE FIRST TWO MAGNETIC BOLTS, WHICH OPERATED AS INTENDED. SURGERY WAS COMPLETED SUCCESSFULLY WITH A DELAY OF APPROXIMATELY 8 MINUTES. THE DEVICE IS ALLEGEDLY AVAILABLE FOR RETURN AND THE REP CAN PROVIDE THE PRIMARY USAGE SHEET, BUT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON AS NO PATIENT HARM WAS PERCEIVED.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 9347280 ↗
• InjuryOct 10, 2019Loss of Osseointegration; Loss of Osseointegration

  AS REPORTED: "PROCEDURE: RIGHT REVISION ANTERIOR TOTAL HIP ARTHROPLASTY ACETABULAR COMPONENT ONLY. PRE-OP DIAGNOSIS: RIGHT FAILED TOTAL HIP ARTHROPLASTY, COMPLICATION OF THE PROSTHETIC HIP IMPLANT. SURGEON COMMENT: PARTIALLY LOOSE CUP DUE TO FIBROUS INGROWTH. NO FURTHER INFORMATION AVAILABLE PER HOSPITAL". A SHELL, SCREW, POLY LINER AND CERAMIC HEAD WERE REVISED.

  Patient problems: Inadequate Osseointegration; Injury

  MAUDE report 9176302 ↗
• InjuryOct 9, 2019Osseointegration Problem; Osseointegration Problem

  THE PATIENT EXPERIENCED A LOT OF PAIN WHEN STANDING UP AND SITTING DOWN. THE CUP FAILED TO HAVE ANY BONY INGROWTH, CREATING A LOOSE FIXATION IN HER ACETABULUM. WE EXPLANTED HER CUP, LINER, SCREW, AND HEAD. IMPLANTED A TRITANIUM II CLUSTER HOLE CUP WITH TWO SCREWS AND A 36MM BIOLOX HEAD AND LINER.

  Patient problems: Inadequate Osseointegration; Injury

  MAUDE report 9173403 ↗
• InjuryOct 4, 2019Osseointegration Problem; Osseointegration Problem

  PHYSICIAN BROUGHT PATIENT TO CHECK FOR INFECTION, FOUND THAT THE CUP WAS LOOSE AND REVISED THE CUP. NO ADDITIONAL INFORMATION. UPDATE (B)(6) 2019 (B)(6): SPOKE TO REP. SURGEON HAD RULED OUT INFECTION UPON DISCOVERY THAT THE SHELL WAS LOOSE.

  Patient problems: Inadequate Osseointegration; Injury

  MAUDE report 9155922 ↗
• InjuryOct 1, 2019Osseointegration Problem; Osseointegration Problem

  AS REPORTED: "...PATIENT CAME INTO THE OFFICE COMPLAINING OF PAIN. AT THAT TIME HE HAD THE PATIENT GET XRAYS OF THE HIP. WITH FURTHER INVESTIGATION IT APPEARED THAT THE CUP HAD LUCENCIES AROUND IT. HE MONITORED THE PATIENTS PAIN AND ACTIVITY LEVELS AND EVENTUALLY DECIDE TO HAVE THE IMPLANT REVISED. UPON REVISING THE CUP IT APPEARED TO HAVE A LITTLE BONY ONGROWTH AROUND PERIMETER OF THE SHELL IN A COUPLE OF SMALL LOCATIONS." UPDATE: "LEFT SIDE."

  Patient problems: Inadequate Osseointegration; Injury; Pain

  MAUDE report 9139484 ↗
• InjuryAug 14, 2019Loss of Osseointegration; Loss of Osseointegration

  PATIENT CALLED STATING SHE HAD A LEFT HIP REPLACEMENT DONE ON (B)(6) 2013. PATIENT REPORTED DISCOMFORT AND STATED HER CURRENT SURGEON NOTED LOOSENING OF THE SHELL. PATIENT WOULD LIKE TO KNOW IF HER IMPLANTS WERE INVOLVED IN A RECALL.

  Patient problems: Discomfort; Inadequate Osseointegration

  MAUDE report 8892292 ↗
• InjuryAug 13, 2019Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT ALLEGEDLY THE PATIENT WAS IMPLANTED WITH A TRITANIUM ACETABULAR CUP IN HER RIGHT HIP ON (B)(6) 2016 AND BEGAN EXPERIENCING PAIN AND DISCOMFORT. IT IS FURTHER ALLEGED DIAGNOSTIC WORKUP REVEALED DEVICE LOOSENING AND IN LIGHT OF WORSENING SYMPTOMS SHE WAS TAKEN BACK FOR REVISION SURGERY TO HER RIGHT HIP ON (B)(6) 2019. ALLEGEDLY "DURING SURGERY, MICROMOTION OF THE CUP WAS OBSERVED. THE REVISION SURGEON NOTED BLACKISH DISCOLORATION AT THE INTERFACE BETWEEN ACETABULAR CUP AND LINER. THE ACETABULAR CUP WAS NOTED TO HAVE BEEN PRIMARILY ADHERED BY FIBROUS TISSUE".

  Patient problems: Discomfort; Inadequate Osseointegration; Injury; Pain

  MAUDE report 8887651 ↗