Trident 621-10-26DRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327037678), received between Apr 9, 2024 and Apr 9, 2024 — classified as 1 injury.

The most frequently reported specific device problem is “Loss of Osseointegration” (1 report).

5 other recalls cover devices cleared under the same FDA submission (K983382, K983502); 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryApr 9, 2024Use of Device Problem; Loss of Osseointegration; Use of Device Problem; Loss of Osseointegration

  RIGHT THA WAS PERFORMED ON (B)(6) 2007. THE PATIENT STARTED GOING TO THE HOSPITAL SEVERAL YEARS AGO DUE TO PAIN OF THE SURGERY SITE. THE DOCTOR POSTPONED THE REVISION SURGERY BECAUSE NO OSTEOLYSIS WAS DETECTED WHILE HE FOUND LOOSENING OF THE CUP. HOWEVER, THE PATIENT COMPLAINED OF INCREASED PAIN AFTER SHE FELL DOWN, SO ON (B)(6) 2024, THE REVISION SURGERY WAS PERFORMED TO REPLACE THE DEVICES (THE CUP, THE INSERT, AND THE HEAD) EXCEPT THE STEM. WHEN THE DOCTOR CHECKED THE REMOVED DEVICES, IT WAS FOUND THAT INNER DIAMETER OF THE REMOVED HEAD WAS 22MM, WHICH WAS DIFFERENT FROM INNER DIAMETER OF THE REMOVED INSERT, 26MM. THE DOCTOR REQUESTS THE STRYKER TO INVESTIGATE WEAR LOCATION AND WEAR DEPTH OF THE INSERT BECAUSE HE SUSPECTS THAT THE WEAR OF THE INSERT IS ONE OF THE ROOT CAUSE OF THE CUP LOOSENING.

  Patient problems: Pain

  MAUDE report 19070373 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K983382, K983502. One submission often covers many models, so check the product and lot details in each record.

• Z-3204-2026 · Jul 30, 2026 · Open, Classified
  TRIDENT 0 POLY INSERT 28mm ID 620-00-28D Orthopaedic implant components manufactured from UHMWPE (polyethylene)
• Z-1043-2015 · Dec 15, 2014 · Terminated
  Trident PSL HA Solid Back 50 mm Includes Dome Hole Plug Ref 540-11-50E Intended for cementless application in a total hip arthroplasty procedure. This system is a two piece ( a s
• Z-0072-2008 · Aug 30, 2007 · Terminated
  Trident PSL HA Cluster Acetabular Shell; Arc Deposited HA Coated Cluster Screw Holes. Hip prosthesis component. Howmedica Osteonics Corp. 325 Corporate Drive; Mahwah, NJ 07430;
• Z-0073-2008 · Aug 30, 2007 · Terminated
  HA Solid Back Acetabular Shell; Arc Deposited HA Coated Included Dome hole Plug; Hip prosthesis component. Sterile; made in USA; Howmedica Osteonics Corp.; 325 Corporate Drive; M
• Z-1261-2007 · Mar 13, 2006 · Terminated
  Trident PSL Acetabular Shell;Arc Deposited;Hydroxylapatite Coated;Cluster Screw Holes;Howmedica Osteonics Corp., 325 Corporate DriveMahway, NJ 07430