Tritanium 502-03-58FRecalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 07613327040159), received between Apr 6, 2017 and Jul 24, 2024 — classified as 25 injuries.

The most frequently reported specific device problem is “Osseointegration Problem” (9 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 25 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• InjuryJun 20, 2022Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO SUSPECTED SHELL LOOSENING AFTER SURGEON OBSERVED LUCENCY VIA X-RAY. SHELL LOOSENING WAS CONFIRMED INTRA-OPERATIVELY. THE SHELL, ONE SCREW, HEAD AND LINER WERE REVISED. 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

  MAUDE report 14749326 ↗
• InjuryMay 25, 2022Corroded; Degraded; Corroded; Degraded

  IT WAS REPORTED BY PATIENT'S ATTORNEY AS A RESULT OF A LEGAL CLAIM THAT ON (B)(6) 2010 THE PATIENT UNDERWENT A RIGHT HIP SURGERY AND WAS IMPLANTED WITH AN LFIT V40 FEMORAL HEAD AND RESTORATION MODULAR HIP SYSTEM. IT IS FURTHER ALLEGED THAT ON (B)(6) 2021 THE PATIENT UNDERWENT RIGHT TOTAL HIP REVISION DUE TO CORROSION AND ADVERSE TISSUE REACTION, OSTEOLYSIS OF THE RIGHT TOTAL HIP REPLACEMENT AND A LARGE PSEUDOTUMOR. *UPDATE ON 05-MAY-2022: "UNDER INDICATIONS THE SURGEON STATES THAT THE PATIENT DEVELOPED A PSEUDO-TUMOR AND ELEVATED COBALT IONS. A REVISION WAS CARRIED OUT. THE SURGEON ALSO NOTED DAMAGE TO THE LOCKING MECHANISM OF THE ACETABULAR COMPONENT AND REVISION OF THE ACETABULAR COMPONENT WAS CARRIED OUT."

  Patient problems: Foreign Body Reaction; Osteolysis

  MAUDE report 14494761 ↗
• InjuryFeb 14, 2022Loss of Osseointegration; Loss of Osseointegration

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

  Patient problems: Inadequate Osseointegration

  MAUDE report 13521922 ↗
• InjuryFeb 4, 2022Unstable; Unstable

  IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED DUE TO METALLOSIS AND INSTABILITY. A COCR HEAD, POLY LINER, SHELL, AND COMPETITOR SCREW WERE REVISED TO A NEW FEMORAL HEAD WITH A COMPETITOR SHELL AND LINER. THE STEM WAS RETAINED. REP CONFIRMED THAT THERE WERE NO ALLEGATIONS AGAINST THE REVISED LINER.

  Patient problems: Foreign Body Reaction; Joint Laxity

  MAUDE report 13452963 ↗
• InjuryOct 14, 2021Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED DUE TO SHELL LOOSENING. THE SHELL, SCREWS, DOME HOLE PLUG (IMPLANTED (B)(6) 2012) AND TROCHANTERIC GRIP PLATE WITH BEADED AND NON-BEADED CABLES, FEMORAL HEAD, MDM METAL LINER, AND ADM/ MDM POLY INSERT (IMPLANTED (B)(6) 2015) WERE REVISED. REP CONFIRMED THERE ARE NO ALLEGATIONS AGAINST THE REVISED HEAD OR LINER COMPONENTS. REP PROVIDED REVISION USAGE AND EXPLANT PICTURES AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Inadequate Osseointegration

  MAUDE report 12633047 ↗
• InjurySep 1, 2021Osseointegration Problem; Osseointegration Problem

  PLANNED ACETABULAR HIP REVISION. CUP WAS REVISED DUE TO A RADIOLUCENT LINE AROUND THE CUP WITH SUSPECTED LOOSENING. CUP WAS EASILY REMOVED WITH IMPACTOR HANDLE WITHOUT FORCE. ACETABULAR COMPONENT REPLACED WITH A TRITANIUM REVISION CUP AND A HEAD CHANGE WAS COMPLETED. PRIMARY HIP WAS UNDERTAKEN ON (B)(6) 2020.

  Patient problems: Inadequate Osseointegration

  MAUDE report 12405739 ↗
• InjuryAug 13, 2021Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THROUGH THE FILING OF A LAWSUIT THAT ALLEGEDLY ON OR ABOUT AUGUST 8, 2016 THE PATIENT UNDERWENT SURGERY OF THE RIGHT HIP AND WAS IMPLANTED A STRYKER TOTAL HIP SYSTEM. IT IS FURTHER ALLEGED THAT ON OR ABOUT (B)(6) 2021 THE PATIENT COMPLAINED OF A STABBING AND RADIATING PAIN IN HIS RIGHT HIP, STIFFNESS, WEAKNESS, LIMITED RANGE OF MOTION AND MOBILITY AND WORSENING PAIN WITH ACTIVITY. THE PATIENT WAS REVISED ON OR ABOUT (B)(6) 2021 AND ALLEGEDLY THE SURGEON INTRAOPERATIVELY NOTED " PSEUDOTUMOR, TRUNNIONOSIS, BLACK STAINED TISSUE AND ADVERSE LOCAL TISSUE REACTION" AND "CUP WAS BROKEN LOOSE WITH MINIMAL EFFORT" AND THERE WAS NO BONY INGROWTH. THE SHELL, LINER AND FEMORAL HEAD WERE REMOVED AND REPLACED.

  Patient problems: Foreign Body Reaction; Inadequate Osseointegration; Loss of Range of Motion; Pain

  MAUDE report 12317897 ↗
• 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) 2019 AND WAS REVISED ON (B)(6) 2019 DUE TO ALLEGED CUP LOOSENING.

  Patient problems: Inadequate Osseointegration

  MAUDE report 11472621 ↗
• InjuryJun 15, 2020Loss of Osseointegration; Loss of Osseointegration

  AS REPORTED: "REVISED IMPLANTS (TRITANIUM SHELL, 2 SCREWS, TRIDENT INSERT, CERAMIC HEAD) DUE TO THE ACETABULAR COMPONENT BEING LOOSE. NO FURTHER INFORMATION AVAILABLE PER HOSPITAL POLICY."

  Patient problems: Injury

  MAUDE report 10152084 ↗
• InjuryMar 30, 2020Loss of Osseointegration; Loss of Osseointegration

  REVISION OF ACETABULAR COMPONENT FOR ASEPTIC LOOSENING.

  Patient problems: Inadequate Osseointegration; Injury

  MAUDE report 9898583 ↗
• InjuryDec 19, 2019Osseointegration Problem; Osseointegration Problem

  REASON FOR REVISION: TRUNNIONOSIS AND GROSSLY LOOSE TRITANIUM SHELL.

  Patient problems: Inadequate Osseointegration; Injury

  MAUDE report 9495545 ↗
• InjuryDec 16, 2019Malposition of Device; Malposition of Device

  AS REPORTED: "WE REMOVED A TRIDENT CLUSTER CUP & ABG MODULAR STEM YESTERDAY. FAILED COMPONENTS: TRIDENT CLUSTER CUP & ABG STEM. ADVERSE CONSEQUENCES: GROIN AND THIGH PAIN. UPDATE: "NO KNOWN ALLEGATIONS AGAINST THE LINER, BIOLOX HEAD, OR DOME HOLE PLUG. RIGHT SIDE. INTRAOP FINDINGS WERE AS FOLLOWS: THE TRIDENT SHELL WAS SUSPECTED TO BE ANTEVERTED TOO MUCH POSSIBLY CAUSING ILIOPSOAS PAIN AND THE ABG STEM WAS CAUSING THIGH PAIN POSSIBLY DUE TO THE STEM BEING LOOSE".

  Patient problems: Injury; Pain

  MAUDE report 9476522 ↗
• InjuryJun 4, 2019Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO SHELL LOOSENING.

  Patient problems: Inadequate Osseointegration; Injury

  MAUDE report 8667487 ↗
• InjuryMay 21, 2019Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO SHELL LOOSENING. THE SHELL, POLY LINER, AND METAL HEAD WERE REVISED TO A COMPETITOR SHELL AND LINER, BIOLOX DELTA CERAMIC HEAD, AND AN ADAPTOR SLEEVE. REP WAS NOT PRESENT FOR THE PROCEDURE. REP PROVIDED STICKERS FOR THE REVISION IMPLANTS AND REPORTED THAT NO FURTHER INFORMATION WILL BE AVAILABLE.

  Patient problems: Inadequate Osseointegration; Injury

  MAUDE report 8627456 ↗
• InjuryMay 13, 2019Osseointegration Problem; Osseointegration Problem

  SURGEON REVISED A CUP, LINER AND HEAD DUE TO PAIN. SURGEON SAID A BONE SCAN SHOWED POSSIBLY LOOSENESS AT A PORTION OF THE CUP. THE CUP WAS A TRITANIUM CUP DONE (B)(6) 2017. SURGEON REVISED TO A TRIDENT MULTI-HOLE CUP AND ELEVATED RIM LINER. UPDATE 16/APRIL/2019 (B)(6): SPOKE TO REP. INTRA-OPERATIVELY, THE SHELL WAS DIFFICULT TO REMOVE FROM THE PATIENT. SURGEON REPORTED THAT THE SHELL'S POSITION WAS NOT AN ISSUE. REP REPORTED THAT NO FURTHER INFORMATION WILL BE AVAILABLE.

  Patient problems: Inadequate Osseointegration; Injury; Pain

  MAUDE report 8603839 ↗
• InjuryMar 22, 2019Osseointegration Problem; Osseointegration Problem

  REVISION HIP DUE TO PAIN. PRIMARY HIP REPLACEMENT (B)(6) 2018. POLYETHYLENE LINER FOUND TO HAVE SMALL METAL LOOKING SCRATCHES ON INNER SURFACE. METAL HEAD HAS SCRATCHED SURFACE TOO. BONE SCREWS WERE ALSO LOOSE AND CUP HAD VERY MINIMAL ON GROWTH OF BONE. ALL ACETABULAR COMPONENTS REMOVED. ACETABULUM REVISED USING COMPETITOR PROSTHESIS.

  Patient problems: Inadequate Osseointegration; Injury; Pain

  MAUDE report 8443360 ↗
• InjuryFeb 4, 2019Malposition of Device; Malposition of Device

  REASON FOR EVENT: ORIGINAL SHELL WAS [IMPLANTED] VERTICALLY. OVER TIME, POLY WEAR MAY HAVE CAUSED AN OSTEOLYTIC RESPONSE AND LOOSENED STEM. SURGERY: SURGEON REMOVED (ACCOLADE CEMENTED STEM, OMNIFIT DISTAL SPACER, BIOLOX 36 -2.5 HEAD, 36F X3 0° LINER, 58FTRITANIUM HEMISPHERICAL CLUSTER HOLE SHELL, AND 2 SCREWS) AND REPLACED WITH A NEW (STRYKER SHELL, LINER, HEAD) AND RESTORATION MODULAR STEM. CUP AND STEM WELL POSITIONED - PATIENT STABLE. SURGEON REPORTED THE SHELL HAD INITIALLY BEEN IMPLANTED IN A VERTICAL POSITION, THE SHELL DID NOT MOVE BUT DID CONTRIBUTE TO LINER WEAR.

  Patient problems: Injury

  MAUDE report 8302370 ↗
• InjuryJan 4, 2019Osseointegration Problem; Osseointegration Problem

  PATIENT CALLED STATING HE HAD A LEFT HIP REPLACEMENT ON (B)(6) 2016. PATIENT WAS REVISED DUE TO LOOSENING ON (B)(6) 2017. PATIENT STATED THE FEMORAL HEAD, STEM AND INSERT WERE REVISED. HIS DOCTOR STATED THE SHELL IS DEFECTIVE.

  Patient problems: Inadequate Osseointegration; Injury

  MAUDE report 8217993 ↗
• InjuryAug 21, 2018Malposition of Device; Positioning Problem; Malposition of Device; Positioning Problem

  PATIENT WAS GETTING OFF THE TOILET AND FELT HIP BECOME UNSTABLE. SHE PRESENTED TO (B)(6)HOSPITAL WITH A DISLOCATED HIP. THE BIPOLAR HEAD FROM THE CONSTRAINED LINER HAD DISENGAGED FROM THE OUTER COMPONENT. ON (B)(6) 2018, DR. (B)(6) PERFORMED AN OPEN REDUCTION, WHERE THE LINER WAS REVISED. THE PATIENT HAD THEIR CUP PREVIOUSLY REVISED FOR RECURRENT DISLOCATION IN (B)(6) 2017. WHEN DR (B)(6) PERFORMED AN OPEN REDUCTION ON (B)(6) 2018, HE COMMENTED THAT THE CUP WASN¿T ANTEVERTED AS IT SHOULD HAVE BEEN.

  Patient problems: Injury

  MAUDE report 7801785 ↗
• InjuryJun 18, 2018Corroded; Loss of Osseointegration; Material Deformation; Corroded; Loss of Osseointegration; Material Deformation

  HIP REVISION - MDM LINER AND TRITANIUM PRIMARY CUP - METAL/METAL WEAR - REMOVED COMPONENTS AND INSERTED ANTIBIOTIC SPACER. PATIENT WAS REVISED DUE TO DEEP INFECTION. PATIENT ALSO HAD A PELVIC FRACTURE AND THE SHELL WAS FOUND TO HAVE MIGRATED MEDIALLY, THROUGH THE MEDIAL WALL. CORROSION ON THE BACK OF THE METAL LINER WAS ALSO REPORTED.

  Patient problems: Bone Fracture(s); Inadequate Osseointegration; Injury; Unspecified Infection

  MAUDE report 7611181 ↗
• InjuryMay 16, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED DUE TO INSTABILITY. AS PER SUPPLIED IMPLANT SHEETS, THE SHELL, LINER, AND HEAD WERE REVISED.

  Patient problems: Injury

  MAUDE report 7520046 ↗
• InjuryFeb 26, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  AN ACETABULAR REVISION WAS PERFORMED.

  Patient problems: Injury

  MAUDE report 7295964 ↗
• InjuryFeb 7, 2018Loss of Osseointegration; Material Deformation; Loss of Osseointegration; Material Deformation

  TRITANIUM CUP WAS EXPLANTED DUE TO LOOSENING AND LOSS OF ORIGINAL CUP POSITION. IN REVISING CUP, IT WAS NOTED THE FIXATION SCREW HAD BROKEN. ORIGINAL IMPLANTS, CUP, LINER, SCREW AND HIP BALL WERE EXTRACTED. A TRITANIUM REVISION CUP, SCREWS, MDM AND HIP BALL WERE IMPLANTED. AS REPORTED IN "HOW WAS ISSUE NOTICED": PATIENT DISCOMFORT.

  Patient problems: Discomfort; Inadequate Osseointegration; Injury

  MAUDE report 7248031 ↗
• InjuryApr 6, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  SALES REP REPORTED THAT PATIENT WAS REVISED FOR PAIN. SURGEON REVISED HER ACETABULAR COMPONENT. RIGHT HIP.

  Patient problems: Injury; Pain

  MAUDE report 6465594 ↗