Trident 643-00-36FRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 07613327025101), received between Apr 5, 2018 and Mar 11, 2024 — classified as 8 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (4 reports).

2 other recalls cover devices cleared under the same FDA submission (K033716); 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryMar 11, 2024Unstable; Unstable

  TOTAL RIGHT HIP REVISION. SURGEON PERFORMED POLY LINER AND FEMORAL HEAD SWAP, TO ADDRESS STABILITY ISSUE IN HIP JOINT.

  Patient problems: Joint Laxity

  MAUDE report 18872817 ↗
• InjuryOct 20, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE CLINICAL TEAM PROVIDED AN OPERATIVE REPORT AND INTRA-OPERATIVE RECORD FOR A REVISION OF THE PATIENT'S RIGHT HIP DUE TO RECURRENT DISLOCATIONS. OP REPORT ALSO STATES THAT THE STEM HAD "MINIMAL ANTEVERSION". A STEM (IMPLANTED IN (B)(6) 2021), AN ELEVATED RIM INSERT AND +7.5 CERAMIC HEAD (IMPLANTED IN (B)(6) 2021) WERE REVISED TO A RESTORATION MODULAR STEM CONSTRUCT, +8 FEMORAL HEAD, ADM/ MDM POLY INSERT, AND MDM METAL LINER.

  Patient problems: Joint Dislocation; Scar Tissue

  MAUDE report 12663145 ↗
• InjurySep 9, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED DUE TO INFECTION. A HEAD AND LINER EXCHANGE WAS PERFORMED. REP CAN PROVIDE THE PRIMARY AND REVISION USAGE SHEETS, AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Unspecified Infection

  MAUDE report 12446176 ↗
• InjurySep 8, 2021Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  WHILE COVERING A REVISION OF THE PATIENT'S LEFT HIP ON (B)(6) 2021, THE REP WAS TOLD THE SURGEON PERFORMED A PRIOR I&D ON THE SAME HIP DUE TO SUSPECTED INFECTION. NO IMPLANTS WERE REVISED AND NO STRYKER REP WAS PRESENT FOR THE PROCEDURE. REP CAN PROVIDE THE PRIMARY USAGE SHEET AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Unspecified Infection

  MAUDE report 12442347 ↗
• InjuryMar 30, 2020Degraded; Insufficient Device Problem Information; Degraded; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY IS SCHEDULED FOR THE PATIENT'S RIGHT HIP ON (B)(6) 2020 DUE TO THE HEAD AND PART OF THE STEM BREAKING OFF FROM THE REST OF THE STEM. UPDATE: "SURGEON REVISED LINER, DO TO WEAR AND TIME FRAME THE CUP HAD BEEN IN PATIENT."

  Patient problems: Injury

  MAUDE report 9898067 ↗
• InjuryJan 20, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED DUE TO DISLOCATION OF THE 36 +0 METAL HEAD FROM THE ELEVATED RIM POLY LINER. SURGEON REPORTED THAT THERE ARE NO ALLEGATIONS AGAINST THE IMPLANTS AND REPORTED A PRE-EXISTING CONTRIBUTING FACTOR: PATIENT HAD AN AMPUTATION WITH PROSTHESIS OF THEIR RIGHT SIDE, RESULTING IN A LEG LENGTH 1" SHORTER THAN THE LEFT LEG. THE HEAD AND LINER WERE REVISED TO AN ADM/MDM LINER CONSTRUCT AND BIOLOX CERAMIC HEAD WITH SLEEVE. REP PROVIDED PRIMARY AND REVISION USAGE REPORTS, AND REPORTED THAT NO FURTHER INFORMATION WILL BE AVAILABLE.

  Patient problems: Injury; Joint Dislocation

  MAUDE report 9608230 ↗
• InjuryJan 17, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED 2 DAYS POST IMPLANT DUE TO DISLOCATION OF THE HEAD FROM THE POLY LINER IN PHYSICAL THERAPY. PATIENT WAS REVISED FROM A 36 +5 BIOLOX HEAD AND TRIDENT X3 POLY LINER TO A 36 +7.5 BIOLOX HEAD AND SAME SIZE LINER. REP PROVIDED PRIMARY AND REVISION USAGE INFORMATION, AND REPORTED THAT NO FURTHER INFORMATION WILL BE AVAILABLE.

  Patient problems: Injury; Joint Dislocation

  MAUDE report 9603196 ↗
• InjuryApr 5, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT HAD A PRIMARY TOTAL HIP REPLACEMENT (B)(6) 2018. HIS POST-OP PERIOD WAS UNREMARKABLE. HE WAS DOING WELL AND EXCEEDED WHAT HE WAS SUPPOSED TO BE DOING. ON (B)(6) 2018 HE BENT OVER AT THE HIP TO PICK UP A LOG. HE DISLOCATED AND WAS BROUGHT THE EMERGENCY ROOM (E.R.) HE WAS REDUCE AND DISLOCATED AGAIN IN THE E.R. COMPONENTS WERE WELL POSITIONED. THE DOCTOR FELT THE PATIENT WOULD BENEFIT FROM A REVISION TO AN MDM. HE WAS REVISED ON (B)(6).

  Patient problems: Injury; Joint Dislocation

  MAUDE report 7400222 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K033716. One submission often covers many models, so check the product and lot details in each record.

• Z-2810-2015 · Jun 25, 2015 · Terminated
  Trident 10 degrees X3 Insert 36 mm ID Catalog #623-10-36I Hip implant component
• Z-0909-2010 · Feb 17, 2006 · Terminated
  Trident Acetabular Hip System Polyethylene Inserts, Stryker Orthopaedics, multiple sizes, Mahwah, NJ. Intended for use in cementless fixation fro use in total hip arthroplasty to