Trident 69-2246Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07613327025453), received between Aug 26, 2019 and Jul 27, 2023 — classified as 4 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (3 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 16, 2026.

Recalls naming this device

1. Jul 30, 2026Open, 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJul 27, 2023Detachment of Device or Device Component; Device Dislodged or Dislocated; Detachment of Device or Device Component; Device Dislodged or Dislocated

  POLY CONSTRAINED LINER HAS LUXATED AND WAS REMOVED.

  Patient problems: Joint Dislocation

  MAUDE report 17403965 ↗
• InjuryJul 27, 2023Detachment of Device or Device Component; Device Dislodged or Dislocated; Detachment of Device or Device Component; Device Dislodged or Dislocated

  POLY CONSTRAINED LINER HAS LUXATED AND WAS REMOVED.

  Patient problems: Joint Dislocation

  MAUDE report 17403091 ↗
• InjurySep 24, 2021Degraded; Fracture; Naturally Worn; Degraded; Fracture; Naturally Worn

  REVISION OPERATION REQUIRED TO CORRECT STRYKER CONSTRAINED LINER IMPINGEMENT WHICH HAD LEAD TO EXCESSIVE PLASTIC WEAR AND THE LINER'S LOCKING RING BREAKING INSITU. UPDATE 23/SEPTEMBER/2021 WG: AS REPORTED IN THE AUGUST 2021 OPERATION REPORT: "...EVIDENCE OF PROSTHETIC IMPINGEMENT WITH BURNISHING OF THE POSTERIOR SUPERIOR PORTION OF THE FEMORAL NECK (REFERRED TO IN THE OP REPORT AS AN 'EXISTING EXETER STEM")¿THE CONSTRAINED RING WAS BROKEN AND A PORTION OF THE ACETABULAR RIM WAS FRACTURED..." BASED ON OP REPORTS AND IMPLANT LOT CODE INFORMATION, THE PATIENT HAD A SPACER REVISION IN (B)(6) 2014 ((B)(4), CONFIRMED VIA OP REPORT). AT THAT TIME, AN EXETER CONTEMPORARY SHELL, STAINLESS STEEL HEAD, AND EXETER STEM WERE PLACED. SOME TIME BETWEEN (B)(6) 2014 AND (B)(6) 2017, SOME OR ALL OF THOSE IMPLANTS WERE REMOVED AND A CONSTRAINED LINER AND COCR FEMORAL HEAD WERE IMPLANTED (NO RECORD PROVIDED FOR THIS SURGERY, BUT THE REVISED HEAD AND LINER WERE NOT MENTIONED IN THE (B)(6) 2014 SURGERY, AND THE CONSTRAINED LINER WAS MANUFACTURED IN JULY 2014). IN AUGUST OF 2021, THOSE IMPLANTS WERE REVISED. THIS PI IS FOR THE REVISION OF THOSE IMPLANTS, IMPLANTED AT AN UNKNOWN DATE AT THE TIME OF REPORT

  Patient problems: Insufficient Information

  MAUDE report 12530443 ↗
• InjuryAug 26, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  A TRIDENT ALL POLY CONSTRAINED CEMENTED LINER WAS IMPLANTED ON (B)(6) 19 AT HOSPITAL TO REVISE A CEMENTED HEMIARTHROPLASTY (NON STRYKER) THAT HAD BEEN DISLOCATING. THE ORIGINAL HEMIARTHROPLASTY WAS IMPLANTED DUE TO FRACTURE BUT THE DATE OF THIS FIRST SURGERY IS UNKNOWN. THE TRIDENT ALL POLY CONSTRAINED LINER HAS NOW ALSO DISLOCATED AND IT APPEARS ON XRAY THAT THE DISSOCIATION HAS OCCURRED BETWEEN THE INNER HEAD AND OUTER HEAD OF THE TRIDENT ALL POLY CONSTRAINED LINER. THE OUTER HEAD APPEARS WELL FIXED AND HAS NOT MOVED. THE STEM (NON STRYKER) APPEARS WELL FIXED AND HAS NOT MOVED. THE HEAD (NON STRYKER) REMAINS ON THE TRUNNION OF THE STEM. SO THE POINT OF DISSOCIATION IS BETWEEN THE ARTICULATING HEADS OF THE TRIDENT ALL POLY CONSTRAINED CEMENTED LINER. THE LOCKING RING ON THE OUTER PART OF THE TRIDENT ALL POLY CONSTRAINED LINER APPEARS INTACT AND UNCOMPROMISED ON TWO VIEWS. UPDATE: "THERE WAS NO ACETABULAR SHELL IN THE PATIENT. THE ALL POLY CONSTRAINED LINER WAS IMPLANTED DIRECTLY INTO THE NATIVE ACETABULUM. THE OUTER PART OF THIS LINER REMAINS IN THE PATIENT¿S NATIVE ACETABULUM. THE INNER PART OF THE CUP DISSOCIATED FROM THE OUTER PART OF THE CUP. IT WAS RESOLVED AT ANOTHER HOSPITA

  Patient problems: Injury

  MAUDE report 8932047 ↗