Tritanium 502-03-52DRecalls & reported problems

Summary

The FDA's MAUDE database contains 39 adverse event reports that list this exact device (DI 07613327040128), received between Mar 13, 2017 and Jan 31, 2024 — classified as 37 injuries, 2 malfunctions.

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.

• InjuryJan 31, 2024Loss of Osseointegration; Loss of Osseointegration

  RIGHT TOTAL HIP ARTHROPLASTY REVISION. COMPLAINTS OF PAIN AND RADIOGRAPHIC DEMONSTRATION OF RADIOLUCENCY AROUND THE ACETABULAR COMPONENT. REVISED FOR ASEPTIC LOOSENING. WAS REVISED TO A COMPETITOR CUP. ACCOLADE STEM RETAINED.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 18619856 ↗
• InjuryNov 23, 2022Loss of Osseointegration; Loss of Osseointegration

  REVISION REPORT AS BELOW: "PRIMARY HIP DONE 2 YEARS AGO. PATIENT HAS COMPLAINED OF PAIN EVER SINCE HAVING IT DONE. BONE SCANS WERE CONDUCTED. FIRST SCAN WAS THOUGHT TO BE FINE. REQUESTED A SECOND SCAN AND DECIDED IT SHOWED SUBTLE SIGNS OF LOOSENING. THE CUP WAS REMOVED DURING THE REVISION ¿VERY EASILY¿ AND THAT NO BONE GROWTH WAS EVIDENT ON THE CUP THUS WAS MICROSCOPICALLY LOOSE."

  Patient problems: Inadequate Osseointegration

  MAUDE report 15852872 ↗
• InjuryOct 26, 2022Degraded; Loss of Osseointegration; Degraded; Loss of Osseointegration

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO SHELL LOOSENING. INTRA-OPERATIVELY, BLACK TISSUE WAS NOTED IN THE PATIENT'S JOINT. A SHELL, 2 SCREWS, LINER AND HEAD WERE REVISED. REP CONFIRMED THERE ARE NO ALLEGATIONS AGAINST THE REVISED LINER.

  Patient problems: Foreign Body Reaction; Inadequate Osseointegration

  MAUDE report 15672254 ↗
• InjuryMar 23, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AS REPORTED: "REVISION TODAY ON A [LEFT] TOTAL HIP. REVISION WAS DUE TO FREQUENT DISLOCATIONS. THE STRYKER CUP WAS REMOVED AND A COMPETITOR CUP WAS IMPLANTED WITH A NEW STRYKER HEAD." SPOKE TO REP. THE ADM/ MDM POLY INSERT WAS SEPARATING FROM THE MDM METAL LINER. REP PROVIDED USAGE SHEETS FOR CURRENT AND PRIOR REVISIONS, AND CONFIRMED THAT THERE WERE NO ALLEGATIONS AGAINST THE REVISED HEAD, AND THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Joint Dislocation

  MAUDE report 13857123 ↗
• InjuryFeb 3, 2022Unstable; Loss of Osseointegration; Unstable; Loss of Osseointegration

  IT WAS REPORTED BY PATIENT'S ATTORNEY AS A RESULT OF A LEGAL CLAIM THAT ALLEGEDLY THE PATIENT UNDERWENT A RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2017. IT IS FURTHER ALLEGED THAT PATIENT EXPERIENCED PAIN AND INSTABILITY AND WAS REVISED FOR ACETABULAR SHELL LOOSENING ON (B)(6) 2019.

  Patient problems: Inadequate Osseointegration; Joint Laxity; Pain

  MAUDE report 13446819 ↗
• InjuryNov 3, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED: "THE REVISION WAS DONE DUE TO DISLOCATION. NO FURTHER INFORMATION IS AVAILABLE FROM THE HOSPITAL." SPOKE TO REP: LEFT HIP, REVISION DUE TO DISSOCIATION OF THE LINER FROM THE SHELL. PATIENT WAS REVISED FROM A TRIDENT CONSTRAINED LINER, SIZE D WITH LFIT V40 22 + 3 MM HEAD TO AN MDM LINER AND INSERT WITH LFIT V40 22 + 8MM V40 HEAD.

  Patient problems: Insufficient Information

  MAUDE report 12745022 ↗
• InjuryMay 5, 2021Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO RADIOLUCENCY OF THE SHELL AND SUSPECTED LOOSENING OF THE SHELL. THE SHELL, A SCREW, LINER, AND BIOLOX HEAD WERE REVISED. REP CONFIRMED THAT THERE ARE NO ALLEGATIONS AGAINST THE REVISED LINER OR SHELL. REP ALSO CONFIRMED THE EXPLANTS MAY BE AVAILABLE FOR RETURN, PICTURES CAN BE PROVIDED, AND THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Inadequate Osseointegration

  MAUDE report 11776089 ↗
• InjuryApr 16, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  DR. REVISED A CUP, LINER AND HEAD DUE TO DISLOCATION. ORIGINAL SURGERY WAS DONE ON (B)(6) 2021. DR. REVISED TO AN MDM. OPERATIVE SIDE: RIGHT.

  Patient problems: Insufficient Information

  MAUDE report 11677496 ↗
• InjuryMar 15, 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 11490412 ↗
• InjuryAug 21, 2020Loss of Osseointegration; Loss of Osseointegration

  PATIENT COMPLAINED OF HIP PAIN, WAS DIAGNOSED WITH A LOOSE TRITANIUM CUP (SIZE 52). DURING REVISION SURGERY, A COMPETITOR CUP WAS USED.

  Patient problems: Injury; Pain

  MAUDE report 10436749 ↗
• InjuryApr 8, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT HAD AN CUP REVISION IN A LEFT HIP BETWEEN (B)(6) 2014 AND THE FEMORAL REVISION ON (B)(6) 2020. AN UNKNOWN INSERT WAS REVISED TO A 40F 0° INSERT. THE REP DOES NOT HAVE ACCESS TO ANY FURTHER INFORMATION AS TO THE DATE OR LOCATION OF THAT REVISION.

  Patient problems: Injury

  MAUDE report 9935523 ↗
• InjuryMar 23, 2020Loss of Osseointegration; Loss of Osseointegration

  THE PATIENT COMPLAINED ABOUT 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, BIOLOX, AND SCREWS.

  Patient problems: Inadequate Osseointegration; Injury

  MAUDE report 9866535 ↗
• InjuryDec 23, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED. AS REPORTED BY REP: "THIS PATIENT'S MUSCULOSKELETAL COMORBIDITIES RESULTED IN MULTIPLE DISLOCATIONS OF THE HIP, REQUIRING REVISION OF THE ACETABULAR COMPONENTS (SHELL, SCREWS, X INSERT, FEMORAL HEAD). NO COMPLAINTS WERE MADE REGARDING THE COMPONENTS THEMSELVES." SPOKE TO REP. THE BIOLOX DELTA CERAMIC HEAD WAS DISLOCATING FROM THE X3 0° POLY INSERT. THERE ARE NO ALLEGATIONS AGAINST THE REVISED STRYKER DEVICES.

  Patient problems: Injury; Joint Dislocation

  MAUDE report 9513188 ↗
• InjuryDec 11, 2019Unstable; Malposition of Device; Unstable; Malposition of Device

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO INSTABILITY. THE PATIENT'S SHELL, HEAD AND LINER WERE REVISED TO A TRIDENT SHELL WITH AN MDM/ ADM LINER CONSTRUCT AND FEMORAL HEAD. REP REPORTED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON. UPDATE NOVEMBER 19, 2019: AS REPORTED BY SALES REP VOICEMAIL, THE SHELL WAS MALPOSITIONED.

  Patient problems: Injury

  MAUDE report 9452325 ↗
• InjuryNov 11, 2019Loss of Osseointegration; Osseointegration Problem; Loss of Osseointegration; Osseointegration Problem

  A TRITANIUM 52MM SHELL WAS REVISED FOR LOOSENING.

  Patient problems: Inadequate Osseointegration; Injury

  MAUDE report 9305782 ↗
• InjuryAug 28, 2019Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE PATIENT'S HIP WAS REVISED DUE TO SUSPECTED LOOSENING. INTRA-OPERATIVELY, THE SURGEON REPORTED THE SHELL WAS MORE INGROWN THAN HE THOUGHT. THE SHELL, LINER, AND BIOLOX HEAD WERE REVISED TO A COMPETITOR SHELL, LINER AND BIOLOX HEAD. REP CONFIRMED THERE ARE NO ALLEGATIONS AGAINST THE HEAD AND LINER, AND REPORTED THAT NO FURTHER INFORMATION WILL BE AVAILABLE.

  Patient problems: Inadequate Osseointegration; Injury

  MAUDE report 8939436 ↗
• InjuryJul 16, 2019Osseointegration Problem; Osseointegration Problem

  THIS PI IS FOR REVISION OF PRIMARY LEFT HIP ON (B)(6) 2017. A REVISION PROCEDURE ON (B)(6) 2017 WAS IDENTIFIED WITH DIAGNOSIS ASEPTIC LOOSENING. A STRYKER SHELL, LINER AND FEMORAL HEAD WERE REVISED TO A COMPETITOR SHELL AND LINER WITH A STRYKER HEAD.

  Patient problems: Inadequate Osseointegration; Injury

  MAUDE report 8795083 ↗
• InjuryJul 16, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  THIS PI IS FOR THE PSOAS RELEASE PROCEDURE OF THE PATIENT'S LEFT HIP IN 2016. A FOLLOW UP NOTE WAS PROVIDED FROM (B)(6) 2016 STATING "THE PATIENT WAS BEING CHECKED UP ON AFTER THE PSOAS RELEASE IN THE LEFT HIP. IT IS NOW A GOOD 2 MONTHS AFTER THE OPERATION. SHE IS DOING WELL. SHE SAID THAT THE PAIN SHE HAD BEFORE THE OPERATION IS COMPLETELY GONE..." NO MENTION OF EXPLANTATION IS MADE.

  Patient problems: Injury; Pain

  MAUDE report 8795079 ↗
• InjuryJun 11, 2019Loss of Osseointegration; Loss of Osseointegration

  PATIENT PRESENTED WITH LOOSE ACETABULAR SHELL. SHELL [AND TWO SCREWS] EXPLANTED AND REVISED. "NO ALLEGATIONS AGAINST HEAD AND LINER."

  Patient problems: Inadequate Osseointegration; Injury

  MAUDE report 8687277 ↗
• InjuryMar 29, 2019Osseointegration Problem; Osseointegration Problem

  PATIENT HAD TOTAL HIP REPLACENT AND SINCE HAS BEEN FEELING A LOT OF PAIN AND AROUND THE IMPLANT. PATIENT HAS NOT BEEN ABLE TO WALK UNATTENDED SINCE THE HIP REPLACEMENT. PATIENT WANTS TO KNOW IF THE PROSTHETIC IS RESPONSIBLE FOR THE PAIN. UPDATE 01 MARCH, 2019: MEDICAL REVIEW CONFIRMED REVISION SURGERY DUE TO LOOSE AND MALPOSITIONED FEMORAL STEM HAS OCCURRED AND ALSO IDENTIFIED THAT THE PRESSFIT ACETABULAR COMPONENT DEMONSTRATES LUCENCIES IN ALL 3 GRUEN ZONES INDICATIVE OF PROBABLE LACK OF FIXATION. ALL COMPONENTS HAVE BEEN REVISED.

  Patient problems: Ambulation or Postural Difficulties; Inadequate Osseointegration; Injury; Pain

  MAUDE report 8466466 ↗
• InjuryMar 25, 2019Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO ACETABULAR LOOSENING. THE SURGEON REPORTED THERE WAS NO INGROWTH ON THE SHELL. A SHELL, 2 SCREWS, HEAD AND LINER WERE REVISED TO A TRIDENT II MULTI HOLE SHELL WITH ADM/ MDM LINER CONSTRUCT AND FEMORAL HEAD. REP REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Inadequate Osseointegration; Injury

  MAUDE report 8450530 ↗
• InjuryFeb 28, 2019Malposition of Device; Malposition of Device

  REVISION OF RIGHT HIP IMPLANTS DUE TO PAIN IN RIGHT HIP. UPDATE 16/JANUARY/2019: REP ORIGINALLY REPORTED STEM, HEAD, AND LINER IN THE PRODUCT GRID. AS REPORTED IN ADVERSE CONSEQUENCES DETAILS: "PATIENT HAD TO HAVE A REVISION OF ORIGINAL IMPLANTS FROM (B)(6) 2016". PRE-REVISION X-RAYS AND PRIMARY IMPLANT SHEET PROVIDED. UPDATE 21/JANUARY/2019: REP PROVIDED ADDITIONAL DETAILS: STEM WAS SOMEWHAT LOOSE. PATIENT WAS REVISED TO COMPETITOR DEVICES.

  Patient problems: Inadequate Osseointegration; Injury; Pain

  MAUDE report 8380257 ↗
• InjuryFeb 19, 2019Osseointegration Problem; Osseointegration Problem

  AS REPORTED: "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 REVISION CUP WITH 2 SCREWS AND A 36MM BIOLOX HEAD AND LINER". REP REPORTED THAT HOSPITAL WOULD NOT ALLOW X-RAYS TO BE SENT BACK TO STRYKER.

  Patient problems: Injury; Pain

  MAUDE report 8349856 ↗
• InjuryJan 15, 2019Osseointegration Problem; Osseointegration Problem

  AS REPORTED: "LOOSE ACETABULUM". DATE OF EXPLANT PROVIDED BY REP CONFIRMS PATIENT WAS REVISED. A 52MM TRIDENT CLUSTER HOLE SHELL, MDM/ADM LINER CONSTRUCT, AND 22.2 LFIT METAL HEAD WERE REVISED.

  Patient problems: Inadequate Osseointegration; Injury

  MAUDE report 8249208 ↗
• InjuryJan 10, 2019Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT PATIENT'S LEFT HIP WAS REVISED DUE TO ASEPTIC LOOSENING OF THE ACETABULAR SHELL (POSSIBLE CAUSES OR CONTRIBUTORS TO LOOSENING WERE NOT REPORTED TO THE REP). THE SHELL, LINER, AND HEAD WERE REVISED.

  Patient problems: Inadequate Osseointegration; Injury

  MAUDE report 8235920 ↗