Tritanium 502-03-48CRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 07613327040111), received between Feb 21, 2018 and Sep 10, 2024 — classified as 10 injuries.

The most frequently reported specific device problem is “Loss of Osseointegration” (3 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• InjuryJun 2, 2021Loss of Osseointegration; Loss of Osseointegration

  "PAINFUL HIP, POSSIBLE LOOSE ACETABULAR COMPONENT." A SHELL, SCREWS, LINER, AND HEAD WERE REVISED. UPDATE: ASEPTIC LOOSENING. THIS IS ALL THE INFORMATION I HAVE, HARD TO GET COOPERATION/INFORMATION FROM INSTITUTION/OFFICES.

  Patient problems: Inadequate Osseointegration

  MAUDE report 11918451 ↗
• InjurySep 9, 2020Loss of Osseointegration; Loss of Osseointegration

  THE SURGEON STATED THAT TRITANIUM LOOSENED. THE PATIENT WAS A 53-YEAR-OLD FEMALE PATIENT (160 CM IN HEIGHT AND 53 KG IN WEIGHT). UPDATE: "THE STEM WAS NOT LOOSE, BUT SINCE THE CUP OPERATION BECOMES DIFFICULT, THE SURGEON ALSO PULLS OUT THE STEM IN CASE OF CUP REPLACEMENT EVEN IF IT IS NOT LOOSE." RIGHT SIDE.

  Patient problems: Inadequate Osseointegration; Injury

  MAUDE report 10507797 ↗
• InjuryApr 14, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT PRESENTED WITH PROTRUSIO OF THE ACETABULAR CUP REQUIRING REVISION. THE PATIENT HAD A HISTORY OF CANCER. WE USED A BONE TAMP TO REMOVE THE FEMORAL HEAD AND MDM INSERT. WE THEN USED THE MDM LINER REMOVAL INSTRUMENT TO TAKE THE LINER OUT OF THE CUP. WE THEN TOOK THE SCREWS OUT OF THE CUP AND USED THE EZ OUT ACETABULAR EXTRACTOR TO TAKE THE CUP OUT. WE REPLACED THE CUP WITH A GAP CUP AND EXETER CEMENTED CUP WITH A 32 HEAD AND FOUND THE JOINT TO BE STABLE.

  Patient problems: Cancer; Injury

  MAUDE report 9957278 ↗
• InjuryFeb 11, 2020Loss of Osseointegration; Loss of Osseointegration

  PATIENT PRESENTED WITH SUSPECTED ASEPTIC LOOSENING OF THE ACETABULAR COMPONENT. THE SURGEON REMOVED THE MDM LINER, INSERT AND 22 HEAD. THEN HE REMOVED THE SCREW IN THE CUP. HE THEN SCREWED IN A CUP IMPACTOR INTO THE CUP AND REMOVED IT, FINDING THAT IT WAS LOOSE. HE REPLACED IT WITH A COMPETITORS CUP AND LINER AND USED OUR V40/C-TAPER SLEEVE AND CERAMIC HEAD.

  Patient problems: Inadequate Osseointegration; Injury

  MAUDE report 9693275 ↗
• InjuryOct 16, 2019Migration; Migration

  THE PATIENT WHO HAD A THA IN 4 YEARS AGO VISITED THE REPORTING HOSPITAL WITH A COMPLAINT OF PAIN. THE X-RAY REVEALED MIGRATION OF TRITANIUM HEMI CLUSTER. WHITE AREA WAS NOTED IN THE X-RAY, AS WELL. NAVIGATION SYSTEM HAD BEEN USED FOR THE THA IN 4 YEARS AGO AND THUS THE OPERATION HAD PERFECTLY COMPLETED. THE CLINICAL COURSE HAS BEEN CAREFULLY OBSERVED AND BEEN WELL DURING POSTOPERATIVE CHECK-UPS. BUT THE PAIN SUDDENLY APPEARED. NOW, AFTER CAREFULLY REVIEWING THE X-RAYS FROM POST-THA UNTIL PRESENT, IT WAS CONFIRMED THAT THE MIGRATION DID PROGRESS GRADUALLY. THE SURGEON IS CONSIDERING FOR THE REVISION IN FUTURE, BUT IT HAS NOT DECIDED SO FAR. THE REPORTER WOULD LIKE TO KNOW ABOUT THE CAUSE OF MIGRATION AND INVESTIGATION OF THE CUP.

  Patient problems: Pain

  MAUDE report 9197469 ↗
• InjuryMay 13, 2019Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED AFTER PATIENT COMPLAINT OF PAIN. SURGEON REPORTED THAT THE SHELL LOOSENED AND LOOKED RETROVERTED. INTRAOPERATIVELY, IT WAS FOUND THAT THE EDGE OF THE SHELL IMPINGED ON THE STEM AND NOTCHED IT, AND THE SURGEON REPORTED THE PRESENCE OF METALLOSIS. THE SHELL AND LINER WERE REVISED, THE STEM AND HEAD WERE RETAINED. THERE ARE NO ALLEGATIONS AGAINST THE LINER (NO WEAR, DISCOLORATION, ETC). PATIENT WAS REVISED TO A TRITANIUM II SHELL AND MDM/ADM LINER CONSTRUCT. REP REPORTED THAT NO FURTHER INFORMATION WILL BE AVAILABLE. UPDATE 16/APRIL/2019: REP WAS ABLE TO PROVIDE A PRE-REVISION X-RAY AND AN INTRA-OPERATIVE PHOTO AND RE-CONFIRMED THAT NO FURTHER INFORMATION WOULD BE AVAILABLE.

  Patient problems: Inadequate Osseointegration; Injury; Pain

  MAUDE report 8606014 ↗
• InjuryMay 8, 2019Osseointegration Problem; Osseointegration Problem

  INFORMATION RECEIVED FROM OPERATIVE REPORT ON 4/11/2019: IT IS REPORTED THAT PATIENT'S RIGHT HIP REVISED DUE TO LOOSENED ACETABULAR COMPONENT. THIS PI HAS BEEN CREATED FOR FIRST REVISION DUE TO ACETABULAR COMPONENT LOOSENING. UPDATE 18/APRIL/2019 (B)(6): AS PER OPERATIVE REPORT, "...HAD INCREASING PAIN TO THE POINT WHERE PATIENT COULDN'T WALK. DURING LAST EVALUATION PATIENT WAS DISCOVERED TO HAVE A GROSSLY LOOSENED ACETABULAR COMPONENT, WITH IMPACTION OF THE BONE...THE ONLY THING BASICALLY HOLDING THIS CUP IN WAS A SCREW...". A 48MM SHELL AND SCREW, 32MM POLY LINER, AND 32MM BIOLOX HEAD WITH ADAPTOR SLEEVE WERE REVISED TO A 54MM SHELL WITH 3 SCREW, MDM LINER, AND +4 UNIVERSAL CERAMIC HEAD.

  Patient problems: Inadequate Osseointegration; Injury; Pain

  MAUDE report 8592780 ↗
• InjuryFeb 6, 2019Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO SUSPECTED SHELL LOOSENING. LOOSENING WAS CONFIRMED INTRA-OPERATIVELY. THE STRYKER SHELL, LINER AND HEAD WERE REVISED TO A COMPETITOR SHELL AND LINER WITH A STRYKER HEAD. THE STEM WAS WELL-FIXED AND NOT REVISED.

  Patient problems: Inadequate Osseointegration; Injury

  MAUDE report 8312689 ↗
• InjuryFeb 21, 2018Malposition of Device; Malposition of Device

  THE SURGEON FOR THIS SESSION FILE CASE HAS COMMUNICATED HIS DOUBTS ABOUT THE ACCURACY OF THE SEGMENTATION OF THIS PATIENT¿S CT. HE HIGHLIGHTED THAT PART OF THE FEMORAL HEAD SEEMS TO BE SEGMENTED AS THE ACETABULUM. DURING THE DISLOCATION OF THE HIP JOINT, THIS PARTICULAR PIECE OF BONE (LOOK LIKE PART OF AN EGG SHELL) FELL OFF FROM THE ACETABULUM. DURING THE REGISTRATION, THE OVERALL ACCURACY WAS VERY BAD (~0.9 TO 1.0 MM) FOR THE FIRST 2 ATTEMPTS. MOST OF THE RED SPOTS LIE WITHIN THE ¿U¿ SHAPED OF THE ACETABULUM, ALMOST ALL THESE RED SPOTS ARE SHOWN AS TOO DEEP IN THE BONE (ABOUT 1.1 MM TO 2.00 MM IN BONE). THE FOSSA AND THE SUPERIOR ACETABULUM REGISTRATION WERE FINE. THE OVERALL ACCURACY WAS REDUCED TO 0.7 MM. SMALL AMOUNT OF OSTEOPHYTES WAS REMOVED ALONG THE SUPERIOR ACETABULUM BEFORE THE REGISTRATION, THE SURGEON WAS REMINDED NOT TO REGISTER THE POINTS ON THE REMOVED ZONE. SURGEON CONCLUDED THAT THE INACCURACY LIE WITHIN THE ACETABULUM REGION, HE DECIDED TO GO AHEAD TO TRY REAMING WITH ROBOT ARM. AFTER THE FIRST ATTEMPT OF REAMING, THE PELVIC CHECKPOINT FELL OFF AND IT WAS VERY DIFFICULT TO RE-ESTABLISH THE CHECKPOINT AS WE ARE UNABLE TO CONCLUDE THE REGISTRATION IS ACCURACY ENOUG

  Patient problems: Bone Fracture(s); Joint Dislocation

  MAUDE report 7285292 ↗