Trident 623-00-40FRecalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 07613327025316), received between Sep 6, 2017 and Jan 18, 2024 — classified as 19 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (6 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• InjuryJan 18, 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) 2016 AND WAS REVISED ON (B)(6) 2021. 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. UPDATE: PER MEDICAL RECORDS RECEIVED: PAIN, OSTEOLYSIS, ALTR DUE TO METALLIC WEAR DEBRIS, AND BONE DEFICIENCY AROUND THE STEM WERE ALSO REPORTED. THE HEAD AND LINER WERE REVISED. THE POLYETHYLENE LINER WAS OBSERVED TO HAVE WORN IN A SYMMETRIC FASHION. THE DALL-MILES CABLE WAS REMOVED AND UNNEEDED. IT WAS LOOSE AND ABRADING THE PROXIMAL PORTION OF THE STEM SLIGHTLY. REPAIR OF THE ABDUCTOR MUSCLE TEAR WAS PERFORMED AS WELL AS A BONE GRAFT AND CEMENT TO ADDRESS THE THIN CORTICAL BONE AROUND THE STEM. THE STEM WAS WELL-FIXED AND NOT REVISED. THE TRUNNION WAS IN USABLE CONDITION WITH MILD VISIBLE BURNISHING AND CORROSION DAMAGE.

  Patient problems: Foreign Body Reaction; Metal Related Pathology; Muscle/Tendon Damage; Osteolysis; Pain

  MAUDE report 18532985 ↗
• InjuryOct 28, 2022Adverse Event Without Identified Device or Use Problem; Noise, Audible; Adverse Event Without Identified Device or Use Problem; Noise, Audible

  THIS PI FOR RIGHT HIP. PATIENT REPORTED A RIGHT HIP REPLACEMENT IN (B)(6) 2015 AND REPORTED PAIN, CLICKING, GRINDING, AND INABILITY TO WALK. PATIENT INQUIRED ABOUT A RECALL.

  Patient problems: Inflammation; Loss of Range of Motion; Pain

  MAUDE report 15690415 ↗
• InjuryOct 26, 2022Degraded; 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 HIS LEFT HIP ON OR ABOUT (B)(6) 2006 AND WAS REVISED ON (B)(6) 2019. IT IS FURTHER ALLEGED THAT HE SUFFERED INJURIES AS A RESULT OF IMPLANTATION AND EXPLANTATION OF THE DEVICE AT ISSUE, DEVICE RECALL AND EXCESSIVE LEVELS OF CHROMIUM AND COBALT IN HIS BLOOD. UPDATE 05-OCT-2022 MF: PER PROVIDED MEDICAL RECORDS: "THE HIP DID IN FACT HAVE TRUNNIONOSIS AND THERE WAS A MODERATE AMOUNT OF BLACKISH MATERIAL AT THE FEMORAL NECK/HEAD JUNCTION AND, HOWEVER, THE TRUNNION FOR THE MOST PART WAS STILL GROSSLY INTACT AND STRUCTURALLY INTACT [...] WHEN THE STEM WAS CHECKED FOR ROTATIONAL STABILITY, THERE WERE BUBBLES AND FLUID COMING OUT OF THE PROXIMAL INTERFACE BETWEEN THE FEMORAL STEM AND THE BONE AND THIS OBVIOUSLY WAS INDICATIVE OF A FEMORAL OF A FIBROUS INTERFACE AND THERE WAS ASEPTIC LOOSENING PRESENT. [...] THE ACETABULAR COMPONENT WAS COMPLETELY WELL FIXED AND DID NOT HAVE EVIDENCE OF OSTEOLYSIS OR EROSION, BUT THE POLYETHYLENE DID HAVE SLIGHT YELLOWISH COLOR DUE TO WHAT APPEARED TO BE SOME EARLY OXIDATION AND THERE WAS ALSO SOME SCRATCHING OF THE POLYETHY

  Patient problems: Metal Related Pathology

  MAUDE report 15672126 ↗
• InjuryMay 25, 2022Degraded; 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 14494677 ↗
• InjuryNov 29, 2021Unstable; Naturally Worn; Unstable; Naturally Worn

  AS REPORTED: "PATIENT HAD STRYKER COMPONENTS IMPLANTED 11 YEARS AGO FROM ANOTHER HOSPITAL AND WAS (B)(6) REPORTING PAIN AND INSTABILITY IN HIS (B)(6). X-RAYS SHOWED ACUTE TRUNNION FAILURE OF HIS HIP STEM AND THE FEMORAL HEAD WAS DISASSOCIATED FROM THE TRUNNION. SURGICAL FINDINGS CONSISTED OF METAL DEBRIS AND ADVERSE LOCAL TISSUE REACTIONS, THE (B)(6) WAS COMPLETELY DISASSOCIATED FROM THE TRUNNION AND THE POLYETHYLENE/ACETABULAR COMPONENT WERE DAMAGED SIGNIFICANTLY. ALL COMPONENTS WERE EXPLANTED AND THE (B)(6) WAS REVISED TO A NEW STRYKER ACETABULAR COMPONENT WITH SCREWS AND A NEW LINER, THE STEM IMPLANTED WAS WITH A COMPETITOR PRODUCT." SPOKE TO REP. IN ADDITION TO DAMAGING THE LINER, THE TRUNNION ALSO DAMAGED THE INTEGRITY OF THE SHELL'S LOCKING MECHANISM, SO IT WAS REVISED. REP PROVIDED A REVISION USAGE SHEET AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Inflammation; Joint Laxity; Pain

  MAUDE report 12888577 ↗
• InjuryOct 22, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  REVISED A HEAD AND LINER IN AN I&D DUE TO INFECTION. UPDATE 29/SEPTEMBER/2021: RIGHT HIP. REP PROVIDED PRIMARY AND REVISION USAGE SHEETS AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Unspecified Infection

  MAUDE report 12681831 ↗
• InjuryJul 1, 2021Naturally Worn; Adverse Event Without Identified Device or Use Problem; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  PATIENT DUE FOR REVISION SURGERY DUE TO EARLY SIGN OF INFECTION. UPON REMOVAL OF THE ORIGINAL POLY THE SURGEON POINTED OUT THAT THE SURFACE WAS SCRATCHED AND WORN. ORIGINAL IMPLANT WITHIN 6 MONTHS OF REMOVAL CAUSED CONCERN. PHOTOS WERE TAKEN AND THE SURGEON REQUESTED THE EXPLANTED PROSTHESIS.

  Patient problems: Unspecified Infection

  MAUDE report 12104251 ↗
• InjuryDec 3, 2020Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  THIS PI WAS RAISED FROM A CLINICIAN REVIEW. MEDICAL REVIEW INDICATES THE PATIENT UNDERWENT PRIMARY HIP ARTHROPLASTY ON (B)(6) 2006 AND WAS SUBSEQUENTLY ADMITTED TO HOSPITAL ON (B)(6) 2006 AND DIAGNOSED WITH INFECTION (STAPH EPIDERMATOUS). HE WAS RELEASED ON (B)(6) 2006 WITH PICC LINE OF INTRAVENOUS ANTIBIOTICS FOR ONE WEEK. THIS PI WAS RAISED FOR THE INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 10941775 ↗
• InjuryMay 8, 2020Fracture; Fracture

  AS REPORTED IN MEDWATCH REPORT # (B)(4): "PATIENT WAS GETTING UP OUT OF HIS CHAIR AT HOME WHEN HE SUDDENLY FELT A POP AND CRACK IN HIS RIGHT HIP. HE PRESENTED TO THE ED ON (B)(6) 2019 WHERE X-RAYS SHOWED A FAILED FEMORAL COMPONENT WITH PRESUMED BROKEN TRUNNION AND DISPLACED FEMORAL HEAD WITH DISLOCATION. ON (B)(6) 2019 HE UNDERWENT A RIGHT TOTAL HIP REVISION". UPDATE 10 APRIL 2020: REVISION SURGERY OPERATIVE NOTES INDICATE THAT THE HEAD DISASSOCIATED FROM THE STEM AND THE SURGEON OBSERVED SIGNIFICANT WEAR OF THE TRUNNION AND METALLOSIS. IT IS ALSO NOTED THAT THE LINER DEMONSTRATED IMPINGEMENT WITH FRACTURING AT THE 1 O'CLOCK POSITION.

  Patient problems: Ambulation or Postural Difficulties; Injury

  MAUDE report 10039337 ↗
• InjuryApr 8, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO RECURRENT DISLOCATIONS OF A COMPETITOR HEAD FROM A LINER. THE PATIENT'S SHELL, 2 SCREWS, AND LINER WERE REVISED TO ANOTHER SHELL AND A LINER OF THE SAME CATALOG NUMBER. THE SURGEON WANTED TO REVISE THE SHELL IN ORDER TO REPOSITION IT. REP PROVIDED PRIMARY AND REVISION USAGE SHEETS AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Injury; Joint Dislocation

  MAUDE report 9938306 ↗
• InjuryMay 2, 2019Degraded; Degraded

  IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED DUE TO TRUNNIONOSIS. INTRA-OPERATIVELY, EXCESSIVE TRUNNION WEAR, A MODERATE AMOUNT OF BLACK TISSUE IN THE PATIENT, AND LINER WEAR WERE NOTED. AN ACCOLADE TMZF PLUS STEM, LFIT V40 HEAD, AND 40F LINER WERE REVISED TO A RESTORATION MODULAR STEM, METAL HEAD, AND LINER. REP PROVIDED PRIMARY IMPLANT STICKERS AND REPORTED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Inflammation; Injury; Reaction

  MAUDE report 8574234 ↗
• InjuryApr 29, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  RIGHT THA ON (B)(6) 2013 UNDERWENT 2 STAGE REVISION ON (B)(6) 2014 THEN (B)(6) 2014 DUE TO INFECTION; ENTIRE THA EXPLANTED AND REPLACED WITH ABX SPACER. PATIENT FACTOR: BMI 32.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 8561402 ↗
• InjuryJan 9, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THROUGH THE SUBMISSION OF A REVISION IMPLANT SHEET THAT PATIENT'S RIGHT HIP WAS REVISED. COMPARING THE USAGE SHEETS FROM (B)(6) 2018 AND THE PRIOR SURGERY (B)(6) 2018, A 40F 0° INSERT WAS SWAPPED OUT FOR THE SAME CATALOG NUMBER, DIFFERENT LOT.

  Patient problems: Injury

  MAUDE report 8231597 ↗
• InjuryNov 5, 2018Deformation Due to Compressive Stress; Device Damaged by Another Device; Scratched Material; Deformation Due to Compressive Stress; Device Damaged by Another Device; Scratched Material

  IT WAS REPORTED THAT SURGEON PERFORMED A RIGHT HIP REVISION (IMPLANTED 10 YEARS AGO) DUE TO THE TRUNNION OF THE STEM BEING WORN DOWN TO A POINT. UPON OPENING, THE HIP CAPSULE, THE SURGEON NOTICED THE HEAD CAME OFF THE TRUNNION DUE TO THE WEAR OF THE TRUNNION WHICH WAS WORN DOWN TO A POINT. SURGEON REPLACED THE STEM, HEAD, AND LINER (CUP REMAINED IMPLANTED) AND REPLACED WITH AN EXETER REVISION STEM AND MATCHING COMPONENTS IMPLANTED AT REVISION. UPDATE FROM SALES REP: THE SURGEON WENT BACK WITH A DJO EXPERT REVISION STEM, NOT AN EXETER REVISION STEM. UPDATE FROM MATERIAL ANALYSIS: DAMAGE CONSISTENT WITH IMPINGEMENT WAS OBSERVED ON THE TRIDENT LINER.

  Patient problems: Injury

  MAUDE report 8038665 ↗
• InjurySep 28, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON (B)(6) 2011 IT WAS NOTED PATIENT FELL IN THE BATHROOM AND X-RAY REVEALED A POSTERIOR DISLOCATION THAT WAS TREATED WITH CLOSED REDUCTION UNDER SEDATION IN THE EMERGENCY ROOM. THE STEM AND HEAD ARE COMPETITOR PRODUCTS.

  Patient problems: Injury; Joint Dislocation

  MAUDE report 7919128 ↗
• InjuryJul 25, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THE PATIENT'S LEFT HIP WAS REVISED AFTER MULTIPLE DISLOCATIONS. PATIENT WAS REVISED TO AN MDM/ADM LINER CONSTRUCT WITH A METAL HEAD.

  Patient problems: Injury; Joint Dislocation

  MAUDE report 7718892 ↗
• InjuryJun 11, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  SUBSEQUENT TO THE REVISION SURGERY FOR THE INTRAPROSTHETIC DISSOCIATION, THE PATIENT UNDERWENT EXTENSIVE REHABILITATION OF THE REVISED HIP AND DEVELOPED A POST-OPERATIVE INFECTION RESULTING IN A 2 STAGE INFECTION SURGERY WITH PLACEMENT OF AN ANTIBIOTIC.

  Patient problems: Unspecified Infection

  MAUDE report 7588202 ↗
• InjuryJan 8, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  DR. (B)(6) PERFORMED AN I&D OF A LEFT HIP AND REPLACED THE LINER AND HEAD.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 7171439 ↗
• InjurySep 6, 2017Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT PRESENTED WITH DISLOCATION. SURGEON PROCEEDED WITH A CONSTRAINED LINER AND CEMENTED INTO A COMPETITOR SHELL. PLACED NEW 28 V-40 HEAD ON PROXIMAL FEMORAL STEM.

  Patient problems: Injury; Joint Dislocation

  MAUDE report 6846446 ↗