Trident 625-0T-32FRecalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 04546540516855), received between Jun 21, 2018 and Sep 6, 2024 — classified as 19 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (4 reports).

1 other recall cover devices cleared under the same FDA submission (P000013); they may or may not involve this specific model.

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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• InjurySep 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY CUSTOMERS SOLICITOR: ON OR AROUND (B)(6) 2008 THE CLAIMANT UNDERWENT A LEFT HIP REPLACEMENT WITH A FOLLOW UP OPERATION ON OR AROUND THE (B)(6) 2009. THE HEAD AND LINER WERE REVISED DUE TO INFECTION, IT WAS NOTED "NO OBVIOUS SIGNS OF INFECTION" IN THE OPERATIVE NOTES.

  Patient problems: Unspecified Infection

  MAUDE report 20155568 ↗
• InjuryJun 17, 2024Degraded; Degraded

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO METALLOSIS. AN ALUMINA HEAD WITH V40 SLEEVE AND ALUMINA INSERT WERE REVISED TO A BIOLOX HEAD WITH SLEEVE, AND TRIDENT POLY INSERT. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Metal Related Pathology

  MAUDE report 19554954 ↗
• InjuryFeb 8, 2023Adverse Event Without Identified Device or Use Problem; Positioning Problem; Adverse Event Without Identified Device or Use Problem; Positioning Problem

  AS REPORTED: "REVISION OF LEFT TOTAL HIP. SURGEON SAYS PATIENT HAS PAINFUL OSTEOLYSIS IN THE GREATER TROCHANTER AND BEHIND THE CUP. SURGEON SAYS CERAMIC LINER MAY NOT HAVE BEEN FULLY SEATED." SPOKE TO REP. A FEMORAL HEAD AND LINER WERE REVISED, SHELL AND SCREW WERE RETAINED.

  Patient problems: Osteolysis; Pain

  MAUDE report 16322613 ↗
• InjuryOct 25, 2021Unstable; Unstable

  IT WAS REPORTED THAT THE PATIENT'S HIP WAS REVISED DUE TO INSTABILITY. THE HEAD AND LINER WERE REVISED. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 12693607 ↗
• InjuryAug 30, 2021Degraded; Material Frayed; Degraded; Material Frayed

  THE SURGEON IS ASKING HAS THERE BEEN ANY PRODUCT WARNINGS ON THE IMPLANTS AS HE SEES EVIDENCE OF METALLOSIS. UPDATE 1 OCTOBER 2021: THERE ARE SIGNS OF WEAR ON THE TRUNNION OF THE ACCOLADE TZMF STEM EVEN THOUGH IT WAS A COC ARTICULATION. NOTICED WHEN PATIENT REPORTED PAIN AND ON SCANS. REVISION COMPLETED ON (B)(6) 2021.

  Patient problems: Insufficient Information; Metal Related Pathology; Pain

  MAUDE report 12385131 ↗
• InjuryOct 30, 2020Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO THE CERAMIC LINER BEING CHIPPED APART AND BROKEN. THE ALUMINA HEAD AND LINER WERE REVISED TO A 36 +7.5 LFIT C-TAPER HEAD AND 36F 10° POLY INSERT. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 10761736 ↗
• InjuryJul 13, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  THE CALLER REPORTED THAT HER HUSBAND HAD AN ABG TRIDENT. CERAMIC ON CERAMIC HIP IMPLANTED IN (B)(6) 2008, AND HAS HAD PAIN SINCE THE IMPLANTS WERE PUT IN. THE PATIENT IS REPORTED TO LIMP, AND HAS ALSO BEEN KNOWN TO COLLAPSE. HE IS CURRENTLY USING CRUTCHES TO HELP HIS MOBILITY. THE SURGEON EXPLAINED THAT ON X-RAY, THE MECHANICS OF THE HIP LOOKED OK, AND THAT THE REPORTED PAIN COULD BE THE RESULT OF SCAR TISSUE. THE SURGEON HAS PRESCRIBED PAIN RELIEF. THE CALLER WOULD LIKE TO KNOW IF THIS PARTICULAR ABG DEVICE WAS AFFECTED UNDER A RECALL.

  Patient problems: Ambulation or Postural Difficulties; Pain

  MAUDE report 10263218 ↗
• InjuryFeb 4, 2020Noise, Audible; Noise, Audible

  IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED DUE TO SQUEAKING. NO POSSIBLE CAUSE OR CONTRIBUTOR FOR SQUEAKING WAS REPORTED OR OBSERVED INTRA-OPERATIVELY. PATIENT'S ALUMINA HEAD AND LINER WERE REVISED TO A 10° TRIDENT X3 INSERT WITH A 36 +0 BIOLOX V40 HEAD. REP HAS PICTURES OF THE EXPLANTS, AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE AVAILABLE.

  Patient problems: Injury

  MAUDE report 9667996 ↗
• InjuryJan 14, 2020Noise, Audible; Noise, Audible

  PATIENT CALLED STATING HE HAD A LEFT HIP REPLACEMENT DONE ON (B)(6) 2008 AND A YEAR AFTER HE STARTED EXPERIENCING A SQUEAKING NOISE WHICH GOT WORSE RECENTLY.

  Patient problems: Injury

  MAUDE report 9587940 ↗
• InjuryNov 27, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED AFTER PATIENT COMPLAINT OF CLICKING. INTRA-OPERATIVELY, IT WAS NOTED THAT THE NECK OF THE STEM WAS IMPINGING ON THE TITANIUM SLEEVE OF THE CERAMIC LINER. THE SHELL, LINER, AND HEAD WERE REVISED. THERE ARE NO ALLEGATIONS AGAINST THE HEAD OR SHELL. PATIENT WAS REVISED TO A TRIDENT SHELL WITH AN MDM/ADM LINER CONSTRUCT AND NEW FEMORAL HEAD. REP REPORTED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Injury

  MAUDE report 9383313 ↗
• InjurySep 17, 2019Degraded; Degraded

  AS REPORTED: "PROCEDURE: LEFT HIP ACETABULAR REVISION. PRE-OP DIAGNOSIS: FAILED LEFT HIP. SURGEON COMMENTS: 'BLACK CORROSION BETWEEN LINER AND CUP'. NO FURTHER INFORMATION AVAILABLE PER HOSPITAL". SPOKE WITH REP. A PRE-REVISION X-RAY AND EXPLANT PICTURES WERE PROVIDED. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE AVAILABLE.

  Patient problems: Injury

  MAUDE report 9075142 ↗
• InjuryJul 18, 2019Fracture; Naturally Worn; Fracture; Naturally Worn

  FRACTURED AND WORN CERAMIC LINER. WORN CERAMIC HEAD. REPLACED LINER AND HEAD AND SLEEVE. REPLACEMENT WAS A X3 POLY LINER AND CERAMIC HEAD AFTER IN-DEPTH DISCUSSION REGARDING BEARING SURFACES AND POSSIBILITY OF CERAMIC FRAGMENTS CAUSING THIRD BODY WEAR OF A POLY LINER. WAS CLIMBING LADDER TO ACCESS TREE APPROX (B)(6) 2012 PRIOR TO REVISION SURGERY. ONLY NOTICED INCREASE IN PAIN, HENCE PRESENTING 2 MONTHS POST EVENT.

  Patient problems: Injury; Pain

  MAUDE report 8804527 ↗
• InjuryJun 6, 2019Noise, Audible; Noise, Audible

  IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED AFTER PATIENT COMPLAINT OF SQUEAKING EVENTUALLY PATIENT COMPLAINT OF A GRINDING NOISE. INTRA-OP AND POST-OP INSPECTIONS FOUND NO FRACTURES, WEAR, OR DAMAGE TO THE CERAMIC HEAD AND LINER. NO CERAMIC DEBRIS WAS NOTED IN THE PATIENT. PATIENT WAS REVISED TO A POLY LINER WITH A CERAMIC HEAD AND SLEEVE.

  Patient problems: Injury

  MAUDE report 8675561 ↗
• InjuryNov 6, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  AS PER MEDICAL RECORDS "ON (B)(6) 2010 AN ASPIRATION OF THE RIGHT HIP UNDER FLUOROSCOPIC CONTROL WAS PERFORMED FOR A DIAGNOSIS OF COMPLAINT OF SWELLING AND FULLNESS OF THE LATERAL AND ANTERIOR GREATER TROCHANTERIC AREA."

  Patient problems: Swelling; Unspecified Infection

  MAUDE report 8042440 ↗
• InjuryNov 1, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AS PER REVIEW OF MEDICAL RECORDS: X-RAY DATED AUGUST 17, 2008 IS AN AP OF THE PELVIS WITH THE LEFT HIP LABELED RIGHT, WHICH IS DISLOCATED WITH A LOOSE ACETABULUM MIGRATED VERTICALLY. X-RAY DATED (B)(6) IS AN AP OF THE LEFT HIP, POST-OP, DEMONSTRATING A REDUCED TOTAL HIP ARTHROPLASTY WITH A LARGER HEAD, MULTIPLE SCREWS, AND NOMINAL POSITION." THIS PI IS FOR DISLOCATION.

  Patient problems: Injury; Joint Dislocation

  MAUDE report 8030857 ↗
• InjuryOct 16, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  REVISION SURGERY FOR PAIN AND A HOT BONE SCAN ON MEDIAL FEMUR.

  Patient problems: Injury; Pain

  MAUDE report 7971502 ↗
• InjuryOct 15, 2018Noise, Audible; Noise, Audible

  SURGEON REMOVED A CERAMIC HEAD AND CERAMIC LINER AND REPLACED WITH A UNIVERSAL BIOLOX HEAD AND POLYETHYLENE LINER. IMPLANTS THAT WERE NOT REMOVED ARE AS FOLLOWS: 6021-0435, LOT 13131801. 542-11-54F, LOT 31334103. UPDATE 19/SEPTEMBER/2018: AS REPORTED IN HOW WAS ISSUE NOTICED: PATIENT HAD PAIN AND HEARD A CLICKING. NO PROBLEMS WERE EVIDENT UPON VISUAL EXAMINATION OF THE REMOVED COMPONENTS.

  Patient problems: Injury; Pain

  MAUDE report 7967507 ↗
• InjuryJul 30, 2018Material Deformation; Material Deformation

  IT WAS REPORTED PATIENT'S LEFT HIP WAS REVISED DUE TO METALLOSIS. PER THE REP, THE CERAMIC LINERS ARE ENCASED BY A METAL OUTER SHELL. THIS METAL PART OF THE LINER SITS PROUD AND WAS IMPINGING ON THE STEM NECK CAUSING THE METAL WEAR.

  Patient problems: Inflammation; Injury; Reaction

  MAUDE report 7731396 ↗
• InjuryJun 21, 2018Crack; Crack

  PATIENT FRACTURE CERAMIC INSERT OF LEFT HIP. AS REPORTED IN ADVERSE CONSEQUENCE DETAILS: "REVISED STEM AND CUP AS IT BECAME APPARENT DURING SURGERY THAT THE FEMORAL [NECK] WAS COMPROMISED DUE TO IMPINGEMENT". ALUMINA HEAD AND 2 SCREWS WERE ALSO REPORTED EXPLANTED PER PRODUCT GRID.

  Patient problems: Injury

  MAUDE report 7627004 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P000013. One submission often covers many models, so check the product and lot details in each record.

• Z-1703-2009 · Jun 9, 2009 · Terminated
  Trident Acetabular System Surgical Protocol. Instructions for use of hip prosthesis. Literature Number LSP55.