Trident 623-00-40ERecalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 07613327025323), received between Jan 6, 2017 and Oct 8, 2024 — classified as 24 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (11 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 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• InjuryOct 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THA FOR LEFT HIP OF THE PATIENT WAS PERFORMED AT ANOTHER HOSPITAL ON (B)(6) 2012. BECAUSE THE HOSPITAL PERFORMED PRIMARY THA WAS CLOSED, THE PATIENT TOOK THE FOLLOW-UP AT THE REPORTED HOSPITAL AND REVISION SURGERY TO REPLACE THE LINER AND THE HEAD WAS PERFORMED ON (B)(6) 2024 BECAUSE OF FUNGAL INFECTION. HOWEVER, SYMPTOMS OF INFECTION WORSEN AND THE RE-REVISION SURGERY TO REMOVE ALL THA IMPLANT DEVICES WAS PERFORMED ON (B)(6) 2024. THIS RECORD WAS OPENED FOR THE REVISION SURGERY ON (B)(6) AND ANOTHER PI WAS OPENED FOR THE REVISION SURGERY ON (B)(6).

  Patient problems: Fungal Infection

  MAUDE report 20404188 ↗
• InjuryJul 3, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  UPDATE: THIS PI IS FOR REVISION OF PATIENT'S LEFT HIP ON (B)(6) 2019. THE PATIENT HAD A REVISION DUE TO HAVING A RECALLED HEAD. THE V40 METAL HEAD AND A POLY LINER WERE REVISED. IT WAS NOTED, "LINER HAD MODEST WEAR PRESENT BUT NO OSTEOLYSIS" ... "THERE WAS BLACK STAINING PRESENT ABOUT THE TRUNNION BUT NO DEFORMATION OF THE TRUNNION." REP REPORTED THAT THE HOSPITAL AND SURGEON WILL NOT RELEASE ANY ADDITIONAL INFORMATION.

  Patient problems: Insufficient Information

  MAUDE report 19669301 ↗
• InjuryDec 12, 2022Fracture; Adverse Event Without Identified Device or Use Problem; Fracture; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE PATIENT'S ATTORNEY AS A RESULT OF A LEGAL CLAIM THAT ALLEGEDLY THE PATIENT WAS IMPLANTED WITH AN V40 COCR LFIT FEMORAL HEAD ON HIS LEFT HIP ON (B)(6) 2009. IT IS FURTHER ALLEGED THAT THE PATIENT EXPERIENCED PAIN. X-RAYS ALLEGEDLY SHOWED "BROKEN, WORN OUT TRUNNION AND THE ACETABULAR SOCKET APPEARED TO BE IN GOOD CONDITION." DURING REVISION SURGERY ON (B)(6) 2020, "THE WORN OUT TRUNNION WAS COMPLETELY CORRODED AND WEARING ON A SUPERIOR PORTION OF THE SOCKET. THE PLASTIC LINER WAS BROKEN IN THIS AREA AS WELL."

  Patient problems: Pain

  MAUDE report 15959068 ↗
• InjuryOct 1, 2022Degraded; Device Dislodged or Dislocated; Naturally Worn; Degraded; Device Dislodged or Dislocated; Naturally Worn

  REVISION SURGERY WAS PERFORMED DUE TO HEAD DISLOCATION AND STEM NECK SHAVING. A BLACK DISCOLORATION OF THE BONE AND SOFT TISSUE WITHIN THE JOINT WERE REVEALED AT THE REVISION. THERE WAS NO BONE FRAGILITY OR SOFT TISSUE LOSS. THE CUP CONTINUED TO BE USED AND THE INSERT WAS REPLACED DUE TO AGE-RELATED WEAR.

  Patient problems: Ambulation or Postural Difficulties; Foreign Body Reaction; Joint Dislocation

  MAUDE report 15525137 ↗
• InjuryMay 24, 2022Degraded; Adverse Event Without Identified Device or Use Problem; Degraded; Adverse Event Without Identified Device or Use Problem

  PATIENT REPORTED HE HAD A LEFT THA ON (B)(6) 2013. PATIENT STARTED TO EXPERIENCE POPPING WHEN WALKING AND VISION ISSUES APPROX TWO YEARS AGO. IN (B)(6) 2021 HIS TASTE BUDS CHANGED AND HE STARTED TO EXPERIENCE PAIN. PATIENT STATED HE HAS BEEN UNABLE TO WORK SINCE (B)(6) 2022 DUE TO HIS PAIN. PATIENT WOULD LIKE TO KNOW IF HIS IMPLANTS ARE PART OF A RECALL. UPDATE PER CONVERSATION WITH PATIENT: PATIENT STATED HE WAS EXPERIENCING VISION PROBLEMS, MUSCLE ACHES AND POPPING OF HIP.

  Patient problems: Joint Laxity; Loss of Range of Motion; Muscle Weakness/Atrophy; Pain; Taste Disorder; Visual Impairment

  MAUDE report 14487600 ↗
• InjuryFeb 21, 2022Material Deformation; Material Deformation

  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) 2012 AND WAS REVISED ON (B)(6) 2019. 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. PER MEDICAL REVIEW: "CUP LOOSE GROSSLY, POLY SEVERELY DAMAGE."

  Patient problems: Ambulation or Postural Difficulties; Pain

  MAUDE report 13573742 ↗
• InjuryJan 5, 2022Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem

  PER MEDICAL RECORDS IN PI, REVISION OF LINER AND FEMORAL HEAD FOR DISLOCATION, SHELL AND SCREWS FOR REVISION FOR UNSPECIFIED REASON. UPDATE:(B)(6) 2014 HEAD AND ACETABULAR REVISION DUE TO CHRONIC DISLOCATION.

  Patient problems: Ambulation or Postural Difficulties; Joint Dislocation

  MAUDE report 13168664 ↗
• InjuryNov 23, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO CHRONIC DISLOCATION OF A COMPETITOR HEAD FROM A STRYKER LINER. THE LINER WAS REVISED TO A CONSTRAINED LINER (HEAD REMAINS COMPETITOR).

  Patient problems: Insufficient Information

  MAUDE report 12860999 ↗
• InjuryOct 22, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A STAGE 1 REVISION WAS PERFORMED ON THE PATIENT'S HIP DUE TO INFECTION. ALL COMPONENTS WERE REMOVED AND A SPACER WAS PLACED. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Unspecified Infection

  MAUDE report 12681834 ↗
• InjurySep 27, 2021Corroded; Corroded

  THE FOLLOWING WAS REPORTED: PATIENT WAS ADMITTED TO HOSPITAL DUE TO PAIN AND LIMB SHORTENING. THE PERFORMED DIAGNOSTICS REVEALED INCORRECT POSITIONING OF THE HIP JOINT PROSTHESIS COMPONENTS, IN PARTICULAR THE STEM AND HEAD (SUSPECTED STEM FRACTURE / RUPTURE). DURING THE REVISION OF THE HIP ARTHROPLASTY ON (B)(6) 2021, SIGNIFICANT ABRASIONS ON THE SURFACES OF THE STEM CONE, HEAD AND POLYETHYLENE INSERT WERE FOUND. DUE TO THE CORRECT SEATING, THE SURGEON DECIDED TO LEAVE THE ACETABULAR COMPONENT.

  Patient problems: Pain

  MAUDE report 12535955 ↗
• InjuryJan 11, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  DR. REVISED A CUP/LINER/HEAD OF A LEFT TOTAL HIP DUE TO DISLOCATION. ORIGINAL SURGERY WAS ON (B)(6) 2019. HE IMPLANTED ANOTHER PRIMARY CUP ADJUSTING THE CUP POSITION RELATIVE TO THE ORIGINAL AND USED MDM. UPDATE 23/DECEMBER/2020: REP PROVIDED PRIMARY AND REVISION USAGE SHEETS AND REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE FROM THE HOSPITAL OR SURGEON.

  Patient problems: Joint Dislocation

  MAUDE report 11151359 ↗
• InjuryJan 5, 2021Degraded; Naturally Worn; Degraded; Naturally Worn

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

  Patient problems: Inflammation; No Information

  MAUDE report 11118321 ↗
• InjuryDec 10, 2020Degraded; Naturally Worn; Degraded; Naturally Worn

  AS REPORTED: "REVISION [RIGHT] TOTAL HIP DONE (B)(6) 2020. LABS DONE FOR INFECTION AT TIME OF SURGERY WERE NEGATIVE. IMPLANTS CAN NOT BE RETRIEVED DUE TO HOSPITALS POLICY." REVISION DUE TO DISSOCIATION OF THE HEAD FROM THE STEM. LINER WEAR NOTED AROUND IT'S RIM. V40 HEAD, 0° POLY LINER, AND TMZF STEM WERE REVISED TO A 10° 36 MM ECCENTRIC LINER AND COMPETITOR FEMORAL COMPONENTS. NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 10982472 ↗
• InjurySep 9, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT UNDERWENT A THA SURGERY ON (B)(6) 2011. THEN, ALL THE IMPLANT WAS REMOVED FROM THE PATIENT DUE TO LOOSENING BY INFECTION. CEMENT MOLD WITH ANTIBIOTIC WAS INSERTED TO THE PATIENT HIP.

  Patient problems: Inadequate Osseointegration; Injury; Unspecified Infection

  MAUDE report 8976499 ↗
• InjuryFeb 21, 2019Unstable; Unstable

  THIS PI IS FOR THE REVISION OF THE PATIENT'S RIGHT HIP DUE TO INSTABILITY. IN REPORTING AN INTRA-OPERATIVE INSTRUMENT BREAKAGE, REP MENTIONED REVISED DEVICES. SPOKE TO REP. PATIENT'S RIGHT HIP WAS REVISED DUE TO INSTABILITY. SURGEON DID NOT REPORT ANY POSSIBLE CAUSE OR CONTRIBUTOR TO INSTABILITY. INTRA-OPERATIVELY, NOTHING WAS FOUND LOOSE, WORN, OR BROKEN. A 21 +20 RESTORATION MODULAR CONE BODY, SIZE 40 METAL HEAD, AND 40E POLY LINER WERE REVISED. REP REPORTED THAT X-RAYS, MEDICAL RECORDS, AND ADDITIONAL INFORMATION ARE NOT AVAILABLE.

  Patient problems: Injury

  MAUDE report 8358624 ↗
• InjuryFeb 8, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT'S RELATIVE REPORTED THAT "MY RELATIVE WHO HAD SURGERY IN 2016 WITH STRYKER PRODUCTS IS HAVING ACHES THESE DAYS. SHE WAS COMPLAINING ABOUT IT."

  Patient problems: Pain

  MAUDE report 8321763 ↗
• InjuryJan 29, 2019Degraded; Naturally Worn; Degraded; Naturally Worn

  THR REVISION. AS YOU WILL SEE FROM THE X-RAY, THE CUP HAD SPUN BUT THE SURGEON WAS ALSO CONCERNED ABOUT POTENTIAL OF METALOSIS. SURGEON SAID MAIN REASON FOR REVISION WAS FOR METALLOSIS. WHEN ASKED IF THE SURGEON WOULD HAVE PERFORMED A REVISION ON SAID PATIENT HAD THE CUP BEEN FIXED APPROPRIATELY AND IN THE RIGHT POSITION, HE SAID HE THINKS SO. HE SAID PATIENT WAS EXPERIENCING A LOT OF PAIN AND HE PUTS THIS DOWN TO THE METALLOSIS BETWEEN HEAD AND TRUNNION. CUP SPINNING WAS NOTICED VIA X-RAY. STEM METALLOSIS/TRUNIONOSIS WAS NOTICED INTRA OP AS SHOWN IN PICTURES. THE FEMORAL HEAD IS ONE OF THE POTENTIALLY AFFECTED HEADS AS NOTED ON THIS YEARS LFIT HAZARD.

  Patient problems: Inflammation; Injury; Reaction

  MAUDE report 8285450 ↗
• InjuryOct 16, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT'S RIGHT HIP WAS REVISED DUE TO ACUTE INFECTION (INFECTION REPORTED BY SURGEON. INFECTING MICROORGANISM NOT IDENTIFIED). HEAD, LINER, AND SLEEVE WERE REVISED TO STRYKER DEVICES.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 7971076 ↗
• InjurySep 19, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  UPDATE PER MEDICAL REVIEW: ON AN (B)(6) 2016 OFFICE VISIT THE PATIENT WAS NOTED TO BE AMBULATING WITH PAIN AND WAS TO RETURN IN SIX MONTHS.

  Patient problems: Ambulation or Postural Difficulties; Pain

  MAUDE report 7890624 ↗
• InjurySep 5, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  BASED ON MEDICAL RECORDS RECEIVED NOTED THAT " ON (B)(6) 2010, AN OPERATIVE REPORT DESCRIBES GENERAL ANESTHESIA FOR AN INCISION AND DRAINAGE AND DEBRIDEMENT OF AN INFECTED LEFT TOTAL HIP ARTHROPLASTY."

  Patient problems: Injury; Pain; Unspecified Infection

  MAUDE report 7847244 ↗
• InjuryJun 26, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT'S RIGHT HIP WAS REVISED DUE TO PAIN. REP REPORTED THAT INTRA-OPERATIVELY, NO DEVICES WERE FOUND LOOSE, FRACTURED, BROKEN, MALPOSITIONED, OR WORN. NO DIAGNOSTIC RESULTS OR PRE-EXISTING PATIENT FACTORS WERE REPORTED TO REP TO IDENTIFY ANY POSSIBLE CAUSE OF PAIN. REP REPORTED THAT NO ADDITIONAL X-RAYS, MEDICAL RECORDS, AND FURTHER INFORMATION ARE AVAILABLE DUE TO HOSPITAL POLICY.

  Patient problems: Injury; Pain

  MAUDE report 7637167 ↗
• InjuryJun 20, 2018Device Dislodged or Dislocated; Insufficient Device Problem Information; Device Dislodged or Dislocated; Insufficient Device Problem Information

  ON (B)(6) 2015 IT WAS NOTED, "TWISTED TO ANSWER THE PHONE" AND THE RIGHT HIP DISLOCATED FOR WHICH SHE UNDERWENT A CLOSED REDUCTION. SHE DISLOCATED AGAIN ON (B)(6) 2015, AND UNDERWENT CLOSED REDUCTIONS. THIS REPORT COVERS THE CLOSED REDUCTION ON (B)(6) 2015.

  Patient problems: Injury; Joint Dislocation; Pain

  MAUDE report 7621513 ↗
• InjuryOct 24, 2017Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  PHYSICIAN REVISED A CUP, LINER AND HEAD/SLEEVE OF A LEFT HIP DUE TO INFECTION.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 6973591 ↗
• InjuryJan 6, 2017Material Separation; Insufficient Device Problem Information; Insufficient Device Problem Information

  AFTER REVISION OF STEM AND INSERT ON (B)(6) BECAUSE DUE TO A DISASSOCIATED HEAD FROM STEM, PATIENT SHOWED SIGNS OF INFECTION AND METAL COLORED FLUID LEAKING FROM INCISION. ALL IMPLANTS WERE REMOVED.

  Patient problems: Complaint, Ill-Defined; Discharge; Failure of Implant; Injury; Reaction; Unspecified Infection

  MAUDE report 6228372 ↗