Tritanium 502-03-54ERecalls & reported problems

Summary

The FDA's MAUDE database contains 39 adverse event reports that list this exact device (DI 07613327040142), received between Jan 11, 2017 and May 24, 2024 — classified as 39 injuries.

The most frequently reported specific device problem is “Loss of Osseointegration” (13 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.

• 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 ↗
• InjuryOct 6, 2023Loss of Osseointegration; Osseointegration Problem; Loss of Osseointegration; Osseointegration Problem

  ACETABULAR HIP REVISION. PRIMARY HIP CONDUCTED (B)(6) 2021, CUP HAS SINCE LOOSENED AND POSITION HAS CHANGED. CUP WAS EASILY REMOVED WITHOUT THE NEED OF AN EXPLANT. NEW CUP IMPLANTED AND CASE COMPLETED SUCCESSFULLY. UPDATE AS PER MED REVIEW: A REVISION ACETABULUM AND FEMORAL HEAD WAS PERFORMED FOR A LOOSE TRIDENT SHELL. THE HIP WAS FOUND TO BE INFECTED BASED ON INTRAOPERATIVE SPECIMENS. THE ROOT CAUSE OF THE REVISION SURGERY WAS A LOOSE ACETABULAR SHELL. THE ROOT CAUSE OF THE LOOSENING WAS LIKELY AN UNDIAGNOSED INFECTION.

  Patient problems: Bacterial Infection; Inadequate Osseointegration

  MAUDE report 17883912 ↗
• InjuryMay 1, 2023Loss of Osseointegration; Malposition of Device; Loss of Osseointegration; Malposition of Device

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO SHELL LOOSENING. A SHELL, MDM METAL LINER, ADM/ MDM POLY INSERT, AND FEMORAL HEAD WERE REVISED TO COMPETITOR ACETABULAR COMPONENTS AND STRYKER FEMORAL HEAD. THERE WERE NO ALLEGATIONS AGAINST THE REVISED HEAD OR LINER CONSTRUCT. REP CAN PROVIDE PICTURES AND CONFIRMED THAT OTHERWISE, NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Inadequate Osseointegration

  MAUDE report 16850667 ↗
• InjuryNov 16, 2021Malposition of Device; Malposition of Device

  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 APRIL 12, 2011 AND WAS REVISED ON (B)(6) 2020. 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. 12 NOV 2021 , EVENT DESCRIPTION UPDATED BASED ON MED REVIEW " METAL-STAINED FLUID IN JOINT. HIP WAS UNSTABLE IN FLEXION AND IR. HEAD REMOVED, SIGNIFICANT METAL CORROSION AND METALLOSIS IN TRUNNION, HAD VISIBLE DAMAGE. SOME OSTEOLYSIS PROXIMALLY. STEM WAS STABLE BUT DECISION TO REMOVE DUE TO ¿DEFECTS¿ AND TO POSITION BETTER FOR STABILITY AND MOBILE BEARING. {....} METAL STAINING OF TISSUE THROUGHOUT. STEM OUT AND MODULAR PLACED. CUP OUT TO PROVIDE MORE ANTEVERSION. NEW CUP 58MM PLACED. DUAL MOBILITY LINER. GOOD STABILITY AND ROM.

  Patient problems: Loss of Range of Motion

  MAUDE report 12819149 ↗
• InjuryJun 29, 2021Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED DUE TO PATIENT COMPLAINT OF LEFT GROIN PAIN. THE SURGEON SUSPECTED ASEPTIC LOOSENING OF THE ACETABULAR COMPONENT. DURING SURGERY, IT WAS OBSERVED THAT THERE WAS A FIBROUS INGROWN CUP. THE REVISION USAGE SHEET WAS PROVIDED. SPOKE TO REP: PICTURES CAN BE PROVIDED, OTHERWISE NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON. THERE ARE NO ALLEGATIONS AGAINST THE REVISED HEAD OR LINER.

  Patient problems: Inadequate Osseointegration

  MAUDE report 12084115 ↗
• InjuryJun 4, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LEFT HIP REVISION FOR PAIN AND ELEVATED COBALT LEVELS. CUP, SCREWS, LINER, INSERT, AND HEAD WERE REMOVED. COMPETITOR CUP IMPLANTED WITH CONSTRAINED INSERT AND A MODULAR CERAMIC HEAD WAS IMPLANTED ON THE STEM. SURGEON NOTED THAT LINER WAS NOT SEATED PROPERLY IN CUP.

  Patient problems: Pain

  MAUDE report 11937120 ↗
• 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) 2016 AND WAS REVISED ON (B)(6) 2020 DUE TO ALLEGED CUP LOOSENING.

  Patient problems: Inadequate Osseointegration

  MAUDE report 11471998 ↗
• InjurySep 14, 2020Loss of Osseointegration; Loss of Osseointegration

  DR. REVISED A CUP/ HEAD/ LINER DUE TO CUP LOOSENING. HE REVISED A TRITANIUM CUP SZ 54 WITH A SINGLE 6.5 X 35 TORX SCREW TO A MULTIHOLE CUP SZ 58. THE ORIGINAL SURGERY WAS DONE ON (B)(6) 2012. REP ALSO REPORTED THAT THE ABOVE REVISED SCREW WAS BROKEN, AND THAT THE TIP OF THE SCREW WAS LEFT IN THE PATIENT'S LEFT HIP.

  Patient problems: Inadequate Osseointegration

  MAUDE report 10527293 ↗
• InjuryJun 30, 2020Degraded; Naturally Worn; Degraded; Naturally Worn

  IT HAS BEEN REPORTED BY THE CUSTOMER THAT THE IMPLANTS WERE REMOVED AFTER 1 YEAR AND 4 MONTHS IMPLANTED IN THE PATIENT DUE TO WEAR.

  Patient problems: Failure of Implant; Injury; Pain

  MAUDE report 10211890 ↗
• InjuryMay 29, 2020Loss of Osseointegration; Loss of Osseointegration

  IN REPORTING A REVISION OF THE PATIENT'S RIGHT HIP ON (B)(6) 2020, REP PROVIDED DOCUMENTS FOR A PRIOR REVISION ON (B)(6) 2019 DUE TO SHELL LOOSENING. REPORTING REP FOR (B)(6) 2020 PROCEDURE WAS NOT PRESENT FOR THE (B)(6) 2019 PROCEDURE. A SHELL, SCREW, LINER, AND FEMORAL HEAD WERE REVISED TO A SHELL WITH 4 SCREWS, A NEW LINER, AND A CERAMIC HEAD WITH SLEEVE. THERE ARE NO ALLEGATIONS AGAINST THE REVISED LINER OR HEAD.

  Patient problems: Injury

  MAUDE report 10103034 ↗
• InjuryApr 15, 2020Loss of Osseointegration; Loss of Osseointegration

  ON (B)(6) 2013, A PATIENT HAD THE PROCEDURE WITH PRIMARY TRITANIUM HEMI CLUSTER HOLE CUP 54MM. AT THE REGULAR VISIT, THE SURGEON NOTICED THAT THE PATIENT HAD PAIN AFTER HEARING FROM HIM CAREFULLY. X-RAY REVELED THAT THE CUP WAS MOVING. IT WAS DUE TO OCCURRENCE OF CLEAR ZONE AND LOOSENING OF THE CUP. THE PATIENT HAD REVISION SURGERY ON (B)(6) 2020. THE REPORTER¿S REQUEST: PLEASE INVESTIGATE, IF BONE TISSUE IS RECOGNIZED OVER THE REMOVED CUP, AND THE CAUSE OF OCCURRENCE OF CLEAR ZONE.

  Patient problems: Injury; Pain

  MAUDE report 9963697 ↗
• InjuryMar 27, 2020Failure to Osseointegrate; Failure to Osseointegrate

  AS REPORTED: "THE PATIENT COMPLAINED ABOUT HIS 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 CUPS SURFACE. WE REPLACED THE CUP, LINER, HEAD, AND SCREWS."

  Patient problems: Inadequate Osseointegration; Injury; Pain

  MAUDE report 9888570 ↗
• InjuryMar 18, 2020Corroded; Unstable; Insufficient Device Problem Information; Corroded; Unstable; Insufficient Device Problem Information

  LEFT HIP REVISION FOR PAIN, PSEUDO TUMOR, AND ELEVATED COBALT LEVELS. CUP, SCREWS, INSERT, AND HEAD WERE REVISED. COMPETITOR CUP, SCREWS, AND INSERT WERE USED ALONG WITH A STRYKER UNIVERSAL TAPER CERAMIC HEAD.

  Patient problems: Foreign Body Reaction; Inflammation; Injury; Joint Laxity; Metal Related Pathology; Pain; Reaction

  MAUDE report 9849937 ↗
• InjuryJan 14, 2020Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED BY THE PATIENT'S ATTORNEY AS A RESULT OF A LEGAL CLAIM THAT THE PATIENT UNDERWENT RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2018. IT IS FURTHER ALLEGED THAT THE PATIENT DEVELOPED PAIN THAT WAS NOT RESOLVING, AND MRI AND RADIOLOGY SUGGESTED LOOSENING OF THE ACETABULAR COMPONENT. THE PATIENT WAS REVISED ON (B)(6) 2019 WHEREBY THE ENTIRE RIGHT TOTAL HIP REPLACEMENT WAS REMOVED AND AN ANTIBIOTIC CEMENT SPACER WAS INSERTED.

  Patient problems: Inadequate Osseointegration; Injury; Pain

  MAUDE report 9588400 ↗
• InjuryDec 19, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT COMPLAINED OF THIGH PAIN, SURGEON RECOMMENDED REVISION (PATIENT REVISED (B)(6) 2019). UPDATE: "THERE WAS NOTHING LOOSE OR BROKEN DISCOVERED IN THE REVISION SURGERY. THE STEM WAS NOT REVISED. NO PICTURES OR X- RAYS ARE AVAILABLE."

  Patient problems: Injury; Pain

  MAUDE report 9495182 ↗
• InjuryNov 4, 2019Osseointegration Problem; Osseointegration Problem

  DR. REVISED A LEFT HIP ORIGINALLY DONE (B)(6) 2013 DUE TO CUP LOOSENING. HE NOTED THE COBALT LEVELS WERE AT 7.7. DURING THE REVISION, DR. OBSERVED BLACK RESIDUE INSIDE THE FEMORAL HEAD WHEN REMOVED. HE NOTED THE SHORT ROTATORS AND POSTERIOR CAPSULAR LIGAMENT AND ABDUCTORS WERE "DEAD." DR. OBSERVED THAT THE STEM TRUNION WAS OKAY AND DECIDED TO LEAVE THE STEM IN PLACE. THE CUP WAS COMPLETELY LOOSE. HE REVISED TO A MULTI-HOLE SIZE 62 AND MDM. UPDATE 10/OCTOBER/2019 WG: REP PROVIDED EXPLANT PICTURES, X-RAYS, USAGE SHEETS FROM PRIMARY AND REVISION SURGERY, AND REPORTED THAT NO FURTHER INFORMATION WILL BE AVAILABLE.

  Patient problems: Inadequate Osseointegration; Inflammation; Injury; Reaction

  MAUDE report 9274453 ↗
• InjurySep 17, 2019Osseointegration Problem; Insufficient Device Problem Information; Osseointegration Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED DUE TO PROGRESSIVE GAIT INSTABILITY. A TRITANIUM CLUSTER 54MM CUP, 3 SCREWS, AND LINER WERE REVISED. THERE ARE NO ALLEGATIONS AGAINST THE LINER. SPOKE TO REP, WHO PROVIDED A PRE-REVISION X-RAY. REP CONFIRMED NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Ambulation or Postural Difficulties; Injury

  MAUDE report 9075127 ↗
• InjuryAug 19, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  ORIGINAL SURGERY DATE 2016 RIGHT HIP REPLACEMENT. UPDATE 25/JULY/2019 (B)(4): AS REPORTED IN ADVERSE CONSEQUENCES DETAILS "PATIENT HAD TO HAVE A 2ND SURGERY TO REPLACE THE ORIGINAL CUP / SHELL."

  Patient problems: Injury

  MAUDE report 8907165 ↗
• InjuryAug 15, 2019Osseointegration Problem; Osseointegration Problem

  THE PATIENT HAD A PRIMARY LEFT HIP REPLACEMENT 3 YEARS AGO. AFTER THE FIRST YEAR PAINED STARTED OCCURRING. SINCE THEN AFTER REGULAR VISITS THE PAIN HAS BECOME UNBEARABLE TO THE POINT THAT SHE WENT TO THE ER EVEN THOUGH SHE WAS SCHEDULED FOR REVISION SURGERY IN TWO WEEKS. DURING REVISION OF THE SHELL LITTLE TO NO BONY ON GROWTH HAD OCCURRED ON THE LOOSE ACETABULAR COMPONENT.

  Patient problems: Inadequate Osseointegration; Injury; Pain

  MAUDE report 8897147 ↗
• InjuryJun 5, 2019Osseointegration Problem; Osseointegration Problem

  A 54MM TRITANIUM CUP WAS LOOSE AND REQUIRED REVISING. THE SINGLE SCREW IN THE CUP WAS BROKEN. UPDATE: RIGHT SIDE.

  Patient problems: Inadequate Osseointegration; Injury

  MAUDE report 8670249 ↗
• InjuryMay 14, 2019Malposition of Device; Malposition of Device

  IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED DUE TO DISLOCATION OF THE HEAD FROM THE LINER. X-RAYS ALSO SHOWED THAT THE CUP WAS MALPOSITIONED. THE SHELL, LINER, AND HEAD WERE REVISED.

  Patient problems: Injury

  MAUDE report 8608573 ↗
• InjuryFeb 14, 2019Malposition of Device; Positioning Problem; Malposition of Device; Positioning Problem

  "PATIENT¿HAD A PRIMARY HIP ARTHROPLASTY PERFORMED¿ON (B)(6) 2011¿ ON OR ABOUT (B)(6) 2018 THE PATIENT WAS RAKING LEAVES AND HEARD A POP. THE PATIENT WAS SEEN BY [SURGEON] ON OR ABOUT (B)(6) 2018 AND BASED ON EXAMINATION AND X-RAY THERE WAS RADIOGRAPHIC EVIDENCE TO PERFORM A FEMORAL HEAD AND X3 POLYURETHANE SWAP OR TOTAL HIP REVISION THAT FOLLOWING WEDNESDAY ((B)(6) 2018). THE COURSE OF ACTION WAS TO BE DETERMINED INTRA-OPERATIVELY. WHEN [SURGEON] OPENED THE HIP CAPSULE, HE STATED THAT THE CAPSULE FLUID AND SURROUNDING TISSUE WAS BLACK WITH SUSPECTED METALLOSIS. [SURGEON] PROCEEDED TO INCISE, DRAIN AND LAVAGE THE SURROUNDING AREA OF AFFECTED TISSUE. HE STATED THAT THE STEM OF THE FEMORAL NECK WAS BROKEN, AND THE X3 POLY WAS CRACKED. HE REMOVED THE BROKEN NECK, X3 POLY AND FEMORAL HEAD. HE PROCEEDED TO START THE REMOVAL OF THE FEMORAL STEM. AN ACCOLADE STEM INSERTER WAS SCREWED INTO THE STEM. HE UTILIZED OSTEOTOMES TO TRY TO SEPARATE BONE FROM THE PROSTHESIS. A DOUBLE RING EXTRACTOR IN CONJUNCTION WITH THE ACCOLADE INSERTER WERE USED TO BACK SLAP THE STEM FROM THE FEMORAL CANAL. AT SOME POINT DURING THE REMOVAL OF THE [STEM], THE FEMUR WAS CRACKED. A RESTORATION MODULAR REVISION STEM

  Patient problems: Inflammation; Injury; Reaction

  MAUDE report 8338842 ↗
• InjuryOct 17, 2018Loss of Osseointegration; Loss of Osseointegration

  AS REPORTED: "ACETABULAR CUP REVISED BECAUSE OF LOOSENING...".

  Patient problems: Inadequate Osseointegration; Injury

  MAUDE report 7975559 ↗
• InjurySep 10, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  SURGEON STATED A PATIENT PRESENTED WITH PAIN POST OP TOTAL HIP REPLACEMENT, AND THAT HE WANTED TO REVISE AN MDM CONSTRUCT TO A STANDARD POLYETHYLENE LINER AND A CERAMIC FEMORAL HEAD. THE MDM LINER WAS REMOVED, AS WELL AS THE 28 MM FEMORAL HEAD WITH AN MDM INSERT. A 0 DEGREE POLYETHYLENE LINER WAS USED, AS WELL AS V40 TO C-TAPER ADAPTOR SLEEVE WAS USED TO CONVERT THE HEAD TO A 36 MM BIOLOX C-TAPER HEAD. UPDATE 15-AUG-2018: AS REPORTED BY REP: "SURGEON STATED THERE MAY HAVE BEEN IMPINGEMENT PRESENT WHICH MAY HAVE BEEN A SOURCE FOR PAIN". IMPINGEMENT WAS BETWEEN THE SHELL AND THE STEM

  Patient problems: Injury; Pain

  MAUDE report 7861838 ↗
• InjuryAug 16, 2018Osseointegration Problem; Osseointegration Problem

  AS REPORTED: "CUP REVISION FOR ASEPTIC LOOSENING. CUP OSTEOTOMES WERE NEEDED TO REMOVE CUP, THEN PLACED A [COMPETITOR] SHELL TO REPLACE THE REMOVED SHELL. NEW 36MM CERAMIC HEAD AND SLEEVE WERE FIXED ON STEM".

  Patient problems: Inadequate Osseointegration; Injury

  MAUDE report 7789124 ↗