Trident 625-0T-36GRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 04546540516862), received between May 31, 2018 and Apr 2, 2026 — classified as 10 injuries.

The most frequently reported specific device problem is “Noise, Audible” (5 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryApr 2, 2026Noise, Audible

  THE FOLLOWING INFORMATION WAS PROVIDED: HIP REVISION OF CERAMIC ON CERAMIC HIP DUE TO PATIENT COMPLAINT OF "SQUEAKING." LEFT HIP.

  Patient problems: Insufficient Information

  MAUDE report 24769946 ↗
• InjuryApr 20, 2022Noise, Audible; Noise, Audible

  AS REPORTED: "LEFT REVISION HIP REPLACEMENT SURGERY. SURGEON COMMENT: PATIENT COMPLAINED OF 'SQUEAKING.'" AN ALUMINA HEAD AND LINER WERE REVISED TO A BIOLOX HEAD AND SLEEVE AND A POLY INSERT.

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 14160175 ↗
• InjuryOct 6, 2020Degraded; Insufficient Device Problem Information; Noise, Audible; Degraded; Insufficient Device Problem Information; Noise, Audible

  REVISION SURGERY ON STRYKER IMPLANTS. REPLACED WITH STRYKER STEM AND FEMORAL HEAD AND DEPUY CUP AND INSERT(B)(6) 2020. PATIENT COMPLAINT OF PAIN AND SQUEEK / CLUNKINESS. SIGNS OF TRUNIONOSIS AND IMPINGEMENT NOTED BY SURGEON. STRIPE WEAR ON CERAMIC HEAD. LINER RIM DAMAGED BY WEAR FROM STEM REVISION ON PREVIOUS PRIMARY SURGERY.

  Patient problems: Metal Related Pathology; Pain

  MAUDE report 10633826 ↗
• InjuryFeb 27, 2020Fracture; Fracture

  THE CUSTOMER REPORTED THAT : "THE TRIDENT RIGHT HIP PROSTHESIS WAS PLACED THE 28/11/07 WITH THE IMPLANTS PROTHEOS. ON (B)(6) 2020 WE PROCEEDED TO CHANGE THE HEAD AND THE INSERT BECAUSE IT BROKE."

  Patient problems: Injury

  MAUDE report 9762866 ↗
• InjurySep 11, 2019Degraded; Degraded

  THE SURGEON REPORTED THAT HE UNDERTOOK A REVISION OF A TRIDENT EXETER HIP. THE CUSTOMER REPORTED THAT THE EXETER TRUNNION WAS WORN. THE CERAMIC HEAD WAS BROKEN AND THE LINER HAD WEAR MARKS.

  Patient problems: Injury

  MAUDE report 8997522 ↗
• InjuryJun 24, 2019Break; Material Fragmentation; Break; Material Fragmentation

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED AFTER PATIENT COMPLAINT OF PAIN. INTRA- OPERATIVELY, BLACK TISSUE AND CERAMIC FRAGMENTS WERE NOTED, AND NO CERAMIC WAS INSIDE OF THE ALUMINA INSERT. THE SHELL, 2 SCREWS, ALUMINA LINER AND ALUMINA HEAD WERE REVISED. REP PROVIDED A PRIMARY OPERATIVE REPORT AND IMPLANT SHEET, PRE-REVISION X-RAYS, AND EXPLANT PICTURES.

  Patient problems: Device Embedded In Tissue or Plaque; Injury; Pain; Reaction

  MAUDE report 8727826 ↗
• InjuryJan 3, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT PRESENTED ACUTELY TO HOSPITAL ON (B)(6) 2018 WITH PAIN, UNABLE TO WEIGHT BEAR AND DISLOCATED HIP. X-RAY TAKEN (PHOTO ATTACHED) AND IT WAS NOTED THAT EXETER STEM WAS BROKEN AT NECK LEVEL. INITIAL OPERATION OCCURRED 9 YEARS EARLIER. REVISION SURGERY WAS PERFORMED AT TAURANGA HOSPITAL ON (B)(6) 2018 AND BROKEN STEM (44#4) ALONG WITH 36+5 ALUMINA CERAMIC HEAD AND 36G ALUMINA CERAMIC LINER WERE REMOVED. (ALL 3 ITEMS BEING RETURNED TO STRYKER AND PHOTOS ATTACHED). CEMENT IN CEMENT REVISION OF STEM PERFORMED (50#2) AND NEW 32+0 BIOLOX CERAMIC HEAD AND 32G 0 DEGREE X3 LINER IMPLANTED. REVISION SURGEON SAID THAT PATIENT HAD PREVIOUSLY DESCRIBED A ¿GRINDING SENSATION¿ IN THE HIP PRIOR TO BREAK.

  Patient problems: Ambulation or Postural Difficulties; Injury; Pain

  MAUDE report 8214877 ↗
• InjuryOct 22, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED BY THE PATIENT AS A RESULT OF A LEGAL CLAIM THAT ALLEGEDLY AFTER THE IMPLANTATION HE DEVELOPED PAIN AND SWELLING WHICH WORSENS AS TIME WENT BY. DURING THE NEXT TWO YEARS BESIDES THE PAIN AND SWELLING THE LEG STARTED TO THUMP WHEN HE WALKED AND SOMETIMES THE HIP WOULD LOCK UP AND COULD NOT MOVE. IT IS FURTHER ALLEGED THAT THE PATIENT WAS REVISED ON (B)(6) 2017 AND DURING THE PROCEDURE THE SURGEON FOUND THAT THE BALL HAD DISINTEGRATED IN THE LEG AND FOUR HOURS WERE SPENT PICKING OUT SHARDS AND SPLINTERS THAT HAD EMBEDDED IN HIS LEG. UPDATE PER MEDICAL REVIEW: ¿ON (B)(6) 2017 HE HAD A LEFT HIP ASPIRATION UNDER LOCAL ANESTHESIA AND FLUOROSCOPIC CONTROL. TOE FLUID WAS SENT FOR GRAM STAIN, CULTURE AND CELL COUNT. LAB REPORT OF RESULTS OF (B)(6) 2017 LEFT HIP ASPIRATE RESULTS: "NO ORGANISMS SEEN" ON GRAM STAIN AND "NO GROWTH AT 3 DAYS" ON CULTURE. CELL COUNT FROM ASPIRATE IS NOT DIAGNOSTIC OF INFECTION.¿ ¿ON (B)(6) 2017 A REVISION LEFT TOTAL HIP ARTHROPLASTY (BOTH COMPONENTS) FOR A PRE­ AND POST-OPERATIVE DIAGNOSIS OF "LEFT HIP PAIN STATUS-POST THA, DISLOCATED LEFT HIP, LOOSENING OF HARDWARE". A BRIEF OPERATIVE REPORT DESCRIBES SPINAL ANESTHESIA AND A LATERAL APPROACH. THE

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

  MAUDE report 7992450 ↗
• InjuryJul 25, 2018Noise, Audible; Noise, Audible

  SURGEON COMMENTED THAT PATIENT WAS EXPERIENCING SOME GROIN PAIN AND SQUEAKING WHILE CLIMBING STAIRS.

  Patient problems: Injury; Pain

  MAUDE report 7718041 ↗
• InjuryMay 31, 2018Migration or Expulsion of Device; Noise, Audible; Migration or Expulsion of Device; Noise, Audible

  IT WAS REPORTED THROUGH THE FILING OF A LAWSUIT, THAT ALLEGEDLY THE PATIENT RECEIVED A TRIDENT CERAMIC ACETABULAR SYSTEM. IT IS ALLEGED THAT PATIENT "HAS SUFFERED AND CONTINUES TO SUFFER BOTH INJURIES AND DAMAGES, INCLUDING BUT NOT LIMITED TO: PAST, PRESENT AND FUTURE PHYSICAL AND METAL PAIN AND SUFFERING AND EXTRAORDINARY LOOSENING AND INFECTION. AS A RESULT OF THE IMPLANTATION OF THE DEVICE, THE PATIENT REQUIRED A REVISION SURGERY ON (B)(6) 2011. UPDATE AS PER MEDICAL REVIEW: CLINICIAN CONCLUDED, "WHILE NO PRE-OP X-RAYS ARE AVAILABLE FOR REVIEW, THE REVISING SURGEON NOTED MALPOSITION OF THE ACETABULAR COMPONENT OF THE PRIMARY TOTAL HIP ARTHROPLASTY RESULTED IN IMPINGEMENT AND SUBLUXATION OF THE CERAMIC-CERAMIC BEARING WITH A SINGLE STRIPE WEAR NOTED ON THE ALUMINA HEAD.

  Patient problems: Injury; Pain; Unspecified Infection

  MAUDE report 7556626 ↗

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.