Trident 690-00-28GRecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 07613327025583), received between Oct 30, 2017 and Aug 30, 2023 — classified as 10 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (9 reports).

1 FDA recall record name this device's identifier, 1 still open.

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 18, 2026.

Recalls naming this device

1. Jul 30, 2026Class IIOpen, Classified

   Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Product has the potential for elevated levels of oxidation, which may result in increased wear, leading to hazards such as excessive wear debris, material fragments, fractured device, or disassociated device. Potential harms include revision surgery, pain, and inflammation.

   Z-3201-2026 · Root cause: Process change control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryAug 30, 2023Detachment of Device or Device Component; Device Dislodged or Dislocated; Detachment of Device or Device Component; Device Dislodged or Dislocated

  THIS PATIENT HAS BEEN REVISED MULTIPLE TIMES DUE TO DISLOCATION. THE DISLOCATION THAT WAS REVISED TODAY WAS DUE TO THE CONSTRAINED LINER DISASSOCIATING FROM THE CUP. IT WAS DISCOVERED THAT THE BIPOLAR HEAD WAS FROZEN INSIDE THE CONSTRAINED INSERT. THERE WAS MOBILITY BETWEEN THE COMPETITOR HEAD AND THE BIPOLAR PORTION BUT THERE WAS NOT MOBILITY BETWEEN THE BIPOLAR AND THE CONSTRAINED INSERT. THE CONSTRAINED IMPLANT WAS REMOVED AND AN MDM WAS PLACED.

  Patient problems: Insufficient Information

  MAUDE report 17648688 ↗
• MalfunctionJul 27, 2022Detachment of Device or Device Component; Device Dislodged or Dislocated; Detachment of Device or Device Component; Device Dislodged or Dislocated

  THE FOLLOWING WAS REPORTED: UPON RANGE OF MOTION CHECK THE FLEXION AND INTERNAL ROTATION OF THE LEG RESULTED IN THE LARGE HEAD DISSOCIATING FROM THE CONSTRAINED LINER. THE TWO PARTS OF THE IMPLANT DISSOCIATED DISLOCATING THE HIP.

  Patient problems: Joint Dislocation

  MAUDE report 15111625 ↗
• InjuryJul 22, 2021Adverse 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. THE ENTIRE HIP CONSTRUCT (STEM WITH CEMENT, HEAD, LINER, SHELL, 6 SCREWS) WAS REMOVED.

  Patient problems: Unspecified Infection

  MAUDE report 12208746 ↗
• InjuryJun 29, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT'S HIP WAS REVISED DUE TO DISSOCIATION OF THE CONSTRAINED LINER FROM THE SHELL. THE CONSTRAINED LINER AND FEMORAL HEAD WERE REVISED. REP CAN PROVIDE AN EXPLANT PICTURE. REP CONFIRMED THAT THERE WERE NO ALLEGATIONS AGAINST THE REVISED FEMORAL HEAD, AND THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Insufficient Information

  MAUDE report 12083392 ↗
• InjuryApr 20, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  THIS PI IS FOR PATIENT 1 OF 2. WHILE REPORTING A REVISION OF ANOTHER PATIENT'S HIP DUE TO DISLOCATION OF A CONSTRAINED LINER FROM A TRIDENT II SHELL, THE SURGEON REPORTED THAT HE FOLLOWED UP WITH THREE ADDITIONAL PATIENTS THAT HAD TRIDENT II SHELLS WITH CONSTRAINED LINERS. TWO OF THE THREE PATIENTS HAVE RESPONDED THAT THEY HAVE HIP PAIN. THOUGH NOT REVISED AND NOT CONFIRMED AS OF THE TIME OF REPORT, THE SURGEON SUSPECTS THOSE PATIENTS MAY ALSO HAVE DISASSOCIATED CONSTRAINED LINERS. THE THIRD ADDITIONAL PATIENT HAS NOT RESPONDED AS OF THE TIME OF REPORT. NONE OF THE LOT CODES FOR EITHER THE INSERTS OR THE SHELLS ARE THE SAME ACROSS THE THREE PATIENTS (THE ONE REVISED, AND THE TWO REPORTING PAIN). UPDATE 25/MARCH/2020 WG: UPON FOLLOW-UP VISIT TO SURGEON, PATIENT SPECIFIED MINOR INCISIONAL PAIN. AFTER RADIOLOGICAL IMAGING AND TRACTION OF THE LEG, THE PATIENT'S HIP CONSTRUCT WAS DETERMINED TO BE WELL-FIXED WITH NO DEVICES DISLOCATED OR DISASSOCIATED. REP REPORTED THAT THE SURGEON WILL NOT RELEASE ANY FURTHER INFORMATION.

  Patient problems: Pain

  MAUDE report 9979218 ↗
• InjuryMar 20, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT PRESENTED ACUTELY WITH A DISLOCATED HIP. ON X-RAY IT WAS EVIDENT THAT THE INNER BIPOLAR OUTER FEMORAL HEAD HAD DISLOCATED FROM THE POLYETHYLENE LINER PORTION OF THE TRIDENT 0 DEGREE CONSTRAINED LINER. PATIENT WAS 3 WEEKS POST OP/IMPLANTATION. SAID HAD BENT FORWARD ONLY A SMALL DEGREE TO PICK SOMETHING UP WITH HER GRASPER AND FELT IT POP OUT.

  Patient problems: Injury; Joint Dislocation

  MAUDE report 9860653 ↗
• InjuryJan 9, 2020Material Separation; Device Dislodged or Dislocated; Material Separation; Device Dislodged or Dislocated

  PATIENT DISLOCATION OF RIGHT HIP REPLACEMENT. DISASSOCIATION OF TRIDENT CONSTRAINED LINER APPARENT ON X-RAY.

  Patient problems: Ambulation or Postural Difficulties; Injury; Joint Dislocation

  MAUDE report 9568176 ↗
• InjuryOct 29, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THIS PI IS FOR REVISION 1 IT WAS REPORTED THAT PATIENT WAS REVISED ON (B)(6) 2019 DUE TO DISLOCATION. UPDATE (B)(6) AS PER EMAIL ATTACHED, THERE WAS NO SECOND REVISION. THIS PI WILL BE CANCELLED AS A DUPLICATE OF PI 7.

  Patient problems: Injury; Joint Dislocation

  MAUDE report 9249401 ↗
• InjuryOct 1, 2019Break; Device Dislodged or Dislocated; Break; Device Dislodged or Dislocated

  THE END USER HAS REPORTED THAT 2.5 MONTHS AFTER THE SURGERY, THE CONSTRAINED INSERT WAS SEPARATED INTO 2 PIECES.

  Patient problems: Injury

  MAUDE report 9139639 ↗
• InjuryApr 3, 2019Device 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 FEMORAL HEAD FROM A STRYKER CONSTRAINED LINER. POSSIBLE CAUSE OR CONTRIBUTOR FOR DISLOCATIONS NOT REPORTED TO THE REP. THE LINER WAS EXCHANGED FOR THE SAME DEVICE (DIFFERENT LOT). REP REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Injury; Joint Dislocation

  MAUDE report 8477785 ↗
• InjuryOct 30, 2017Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT'S LEFT HIP WAS REVISED DUE TO A DISLOCATED CONSTRAINED LINER. PATIENT WAS REVISED TO STRYKER COMPONENTS. REP CONFIRMED THAT ONLY THE LINER WAS EXPLANTED. UPDATE: SALES REP CONFIRMED THAT IT WAS THE CONSTRAINED LINER THAT DISLOCATED (DISASSOCIATED) FROM ITSELF AND NOT FROM THE SHELL.

  Patient problems: Injury

  MAUDE report 6986660 ↗