Trident X3 Insert 723-00-36ERecalls & reported problems

Summary

The FDA's MAUDE database contains 43 adverse event reports that list this exact device (DI 07613327341959), received between Jul 27, 2021 and Sep 11, 2026 — classified as 43 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 43 reports, in the reporter's own words as published by the FDA.

• InjurySep 11, 2026Adverse Event Without Identified Device or Use Problem

  The following information was provided: Patient's left hip explanted in its entirety due to infection. A Biomet spacer was implanted. No other information available due to Hospital policy.

  Patient problems: Unspecified Infection

  MAUDE report 50728908 ↗
• InjurySep 2, 2026Mechanical Problem

  Patient problems: Loss of Range of Motion; Pain

  MAUDE report 50564009 ↗
• InjuryJul 29, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient's Left hip was revised due to infection. An I&D with washout and head/ liner exchange was performed. Rep confirmed that no further information will be released by the hospital or surgeon.

  Patient problems: Unspecified Infection

  MAUDE report 50072059 ↗
• InjuryJul 10, 2026Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING INFORMATION WAS PROVIDED: IT WAS REPORTED THE PATIENT'S RIGHT HIP WAS REVISED DUE TO POSSIBLE INFECTION. A WASHOUT WITH HEAD AND LINER EXCHANGE WAS PERFORMED. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Unspecified Infection

  MAUDE report 25780527 ↗
• InjuryMay 12, 2026Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING INFORMATION WAS PROVIDED: A PATIENT WHO UNDERWENT TOTAL HIP ARTHROPLASTY (THA) AT ANOTHER HOSPITAL ON (B)(6) 2024 DEVELOPED AN INFECTION, AND ALL IMPLANTS WERE REMOVED ON (B)(6) 2026.

  Patient problems: Unspecified Infection

  MAUDE report 25147074 ↗
• InjuryApr 28, 2026Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING INFORMATION WAS PROVIDED: THE PATIENT IS PART OF THE INSIGNIA HIP STEM STUDY AND DURING A ROUTINE ON SITE MONITORING VISIT IT WAS NOTED ON THE 2 YEAR PHONE EVALUATION ((B)(6) 2025) WHERE THE PATIENT IS ARE ASKED WHETHER THEY HAVE PAIN, ARE SATISFIED WITH THE SURGERY AND IF THE HIP IS STILL IN PLACE, THE PATIENT REPORTED THAT SHE WAS NOT SATISFIED WITH THE SURGERY. THERE WAS NO REPORT OF PAIN AND THE PATIENT DID NOT PROVIDE ANY COMMENTS. THE CLINIC NOTE FROM (B)(6) 2025 MENTIONS SHE HAS CHRONIC BILATERAL ILIOPSOAS TENDONITIS. THE PATIENT WILL BE FOLLOWED TO ASSESS FURTHER.

  Patient problems: Inflammation; Muscle/Tendon Damage

  MAUDE report 25019354 ↗
• InjuryApr 28, 2026Unstable

  THE FOLLOWING INFORMATION WAS PROVIDED: REVISED A STRYKER HIP (LEFT). COMPONENTS ARE BEING REVISED DUE TO INSTABILITY. NO VISIBLE SIGNS OF DAMAGE NOR WEAR TO ANY OF THE COMPONENTS. NO FURTHER INFORMATION TO BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Joint Laxity

  MAUDE report 25017322 ↗
• InjuryDec 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO NEW INFORMATION.

  Patient problems: Unspecified Infection

  MAUDE report 23826908 ↗
• InjuryDec 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO INFECTION. SURGEON'S ORIGINAL PLAN WAS TO PERFORM A POLY SWAP. HOWEVER, IN TRYING TO REMOVE THE LINER, THE SHELL SPUN OUT (REP CONFIRMED THIS WAS NOT DUE TO SEPTIC LOOSENING BUT INSTEAD DUE TO THE SHELL BEING IMPLANTED LESS THAN 3 WEEKS PRIOR). REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Unspecified Infection

  MAUDE report 23708906 ↗
• InjurySep 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO NEW INFORMATION.

  Patient problems: Insufficient Information

  MAUDE report 23134500 ↗
• InjurySep 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED DUE TO INFECTION. A HEAD AND LINER EXCHANGE WAS PERFORMED. ADDITIONALLY, THE OFFSET OF THE FEMORAL HEAD WENT FROM A -2.5 TO A +0 TO ENSURE STABILITY PROPHYLACTICALLY. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Unspecified Infection

  MAUDE report 22944829 ↗
• InjuryJun 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT IS STATUS POST REVISION RTHA DO TO INFECTION. NO ADDITIONAL DETAILS WERE PROVIDED BY THE FACILITY.

  Patient problems: Unspecified Infection

  MAUDE report 22229529 ↗
• InjuryFeb 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD A PRIMARY RIGHT THA ON (B)(6) 2022. THE PATIENT DEVELOPED PJI. THE PATIENT WAS REVISED ON (B)(6) 2023. ALL COMPONENTS WERE EXCHANGED.

  Patient problems: Unspecified Infection

  MAUDE report 21342986 ↗
• InjuryNov 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO INFECTION. AND I&D WITH HEAD AND LINER EXCHANGE WAS PERFORMED. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Unspecified Infection

  MAUDE report 20628541 ↗
• 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 IN (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 20404193 ↗
• InjurySep 4, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PT. PRESENTED WITH A DISLOCATED RIGHT HIP. DR. OPTED TO SWAP THE EXPLANTED ITEMS TO AN MDM CONSTRUCT. THE ORIGINAL SHELL AND STEM WERE LEFT IN-SITU. THE "IN/OUT" ITEMS WERE EXCHANGED DUE TO "NEEDING MORE LENGTH AND OFFSET" THAN THE 28MM+0 PROVIDED WHEN TESTED FOR STABILITY. NO COMPLAINTS FILED AGAINST THE COMPONENTS THEMSELVES, NO FURTHER INFO AVAILABLE.

  Patient problems: Joint Dislocation

  MAUDE report 20140627 ↗
• InjuryJun 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT'S LEFT HIP WAS REVISED DUE TO INFECTION. ALL IMPLANTS WERE REMOVED. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Unspecified Infection

  MAUDE report 19601156 ↗
• InjuryJun 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A LEFT HIP REVISION DUE TO INFECTION. SURGEON PERFORMED A WASHOUT WITH I&D. THE HEAD AND LINER WERE REPLACED.

  Patient problems: Unspecified Infection

  MAUDE report 19549066 ↗
• InjuryJun 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED DUE TO POTENTIAL INFECTION (SURGEON REPORTED PATIENT WAS APPLYING OINTMENT TO SURGICAL WOUND AGAINST MEDICAL ADVICE, CAUSING WOUND ISSUES AND CONCERN FOR INFECTION). A HEAD AND LINER EXCHANGE WAS PERFORMED. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Unspecified Infection

  MAUDE report 19458092 ↗
• InjuryMay 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  POST IMPLANT ON (B)(6) 2023 DEVELOPED SWELLING AND DEHISCENCE; TO ED ON (B)(6) 2023 AND HAD EXPLANT OF ALL DEVICE ON (B)(6) 2023 (RIGHT REVISION THA WITH INSERTION OF CEMENTED TOTAL HIP/ANTIBIOTIC SPACER. THE PATIENT INITIALLY HAD A THA ON (B)(6) 2023. SHE HAD WOUND DEHISCENCE THEREAFTER AND DEVELOPED A SEPTIC PROSTHETIC JOINT. SHE WAS ADMITTED TO HF WHERE SHE UNDERWENT I&D OF THE WOUND ON (B)(6) AND THEN REVISION OF THE ARTHROPLASTY WITH ABX SPACER PLACEMENT (B)(6). BCX WERE POSITIVE FOR MSSA. DEEP WOUND CX POSITIVE FOR MSSA AND ENTEROBACTER CLOACAE. ID WAS CONSULTED AND SHE WAS TREATED WITH IV ERTAPENEM AND NAFCILLIN AND DISCHARGED TO REGENCY ON (B)(6) WITH A PLAN FOR 6 WEEKS OF IV ABX WITH LIKELY ORAL TRANSITION THEREAFTER. THE PATIENT DEVELOPED RIGHT HIP PAIN AND INCREASED DRAINAGE AND WAS SENT BACK TO THE HOSPITAL FOR REEVALUATION. CT ABDOMEN AND PELVIS SHOWED AT 3.2 X 1.7 X 8 CM ABSCESS IN THE RIGHT ILIACUS MUSCLE AND GAS AND FLUID COLLECTION WITHIN THE MUSCULAR COMPARTMENT OF THE ANTEROLATERAL RIGHT THIGH THAT APPEARED TO BE CONTIGUOUS WITH THE JOINT SPACE. BLOOD CULTURES (B)(6)WERE 2 OF 2 POSITIVE FOR ENTEROCOCCUS FAECIUM. REPEAT BLOOD CULTURES (B)(6) WERE 1/2 POSITIVE FOR

  Patient problems: Bacterial Infection; Swelling/ Edema; Wound Dehiscence

  MAUDE report 19265706 ↗
• InjuryFeb 18, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  DOCTOR REVISED A LEFT HIP LINER/HEAD DUE TO DISLOCATION. HE CHANGED FROM A 36 - 5 TO A 42 MDM WITH 28 + 4 HEAD. ORIGINAL DOS WAS (B)(6) 2022.

  Patient problems: Joint Dislocation

  MAUDE report 18728533 ↗
• InjuryAug 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD A RIGHT HIP FRACTURE AND WAS TREATED WITH AN INDEX THA ON (B)(6) 2022. PATIENT DEVELOPED PJI, AND WAS REVISED ON (B)(6) 2022. ALL COMPONENTS WERE EXCHANGED. THE PATIENT IS NOW DECEASED.

  Patient problems: Unspecified Infection

  MAUDE report 17476522 ↗
• InjuryJul 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO INFECTION. AN I&D WAS PERFORMED ALONG WITH A HEAD (IMPLANTED (B)(6)2023) AND LINER (IMPLANTED (B)(6)2023) EXCHANGE. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Unspecified Infection

  MAUDE report 17347152 ↗
• InjuryMay 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED. AS REPORTED: "PT. PRESENTED WITH A DRAINING SURGICAL WOUND. DR. SUSPECTED AN ACUTE INFECTION OF THE HIP. INITIAL RESULTS INDICATE THE PT. DOES NOT HAVE AN INFECTION BUT A SUPERFICIAL HEMATOMA/SEROMA. DR. OPTED TO INSPECT THE WOUND-CLOSURE LAYERS DOWN TO THE JOINT, PERFORM AN I&D, AND SWAP OUT THE MODULAR COMPONENTS(FEMORAL HEAD AND ACETABULAR INSERT). NO COMPLAINTS HAVE BEEN FILED AGAINST THE COMPONENTS THEMSELVES."

  Patient problems: Hematoma

  MAUDE report 17025763 ↗
• InjuryJan 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS REPORTED: SUBJECT ADMITTED TO THE HOSPITAL FOR AN INFECTION AND HAD AN I&D AND HEAD AND LINER EXCHANGE. REP INFORMED THAT THE EXPLANTED DEVICES ARE NO LONGER AVAILABLE.

  Patient problems: Unspecified Infection

  MAUDE report 16230882 ↗