Trident 625-0T-28DRecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 04546540516831), received between Sep 4, 2018 and Nov 15, 2024 — classified as 9 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Degraded” (4 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. How this data works · Data updated Oct 13, 2026.

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.

• InjuryNov 15, 2024Degraded; Degraded

  THE SURGERY WAS PERFORMED IN SHANGHAI 13 YEARS AGO. X-RAYS SHOWED OSTEOLYSIS AND IMPLANT DAMAGE. AFTER CONSULTATION BETWEEN THE DOCTOR AND THE COMPETITOR'S SALES REP, THE PRODUCT WAS MOST LIKELY A STRYKER PRODUCT. THE DETAIL OF THE PRODUCT IS UNKNOWN. REVISION SURGERY IS SCHEDULED TO TAKE PLACE IN THE NEAR FUTURE, BUT THE DATE HAS NOT YET BEEN DETERMINED. PRODUCT APPEARS TO BE TRIDENT ALUMINA INSERT.

  Patient problems: Osteolysis

  MAUDE report 20696319 ↗
• InjuryApr 9, 2024Noise, Audible; Noise, Audible

  IT WAS REPORTED THAT "PATIENT ALLEGEDLY FELT SOME SQUEAKING AND MILD GRINDING OF HER HIP IMPLANT. SHE CLAIMS THAT HER HIP GAVE OUT WHILE STEPPING OUT OF THE SHOWER. PATIENT WAS BEING REVISED FOR POSSIBLE FRACTURED CERAMIC HEAD."

  Patient problems: Insufficient Information

  MAUDE report 19070220 ↗
• InjuryFeb 15, 2023Degraded; Insufficient Device Problem Information; Degraded; Insufficient Device Problem Information

  THE FOLLOWING WAS REPORTED: A SURGERY TO REMOVE AND REPLACE THE CERAMIC LINER WAS PERFORMED BASED ON THE CT DATA, WHICH APPEARED TO BE DAMAGED LINER. A HARD OBJECT WAS FOUND DURING THE PROCEDURE. CAN YOU PLEASE INVESTIGATE WHETHER THE ALUMINA CERAMIC LINER IS DAMAGED AND WHAT THE HARD OBJECT IS? REASON FOR REVISION WAS DUE TO PAIN.

  Patient problems: Pain

  MAUDE report 16383676 ↗
• InjuryNov 30, 2021Material Erosion; Material Erosion

  THA WAS PERFORMED ON (B)(6) 2008 (J543-11-46D, 625-0T-28D). REVISION WAS PERFORMED ON (B)(6) 2021 DUE TO METALLOSIS. THERE WAS OSTEOLYSIS AROUND THE ACETABULUM AND PROXIMAL STEM AND IT WAS TREATED WITH VANCOMYCIN AND BONE GRAFT. THE LINER AND HEAD WERE REPLACED. THE BACK OF THE LINER SHOWED METAL WEAR DEBRIS. THE DOCTOR WOULD LIKE TO KNOW WHICH PART OF THE LINER IS WORN AND HOW MUCH. ORIGINALLY, IS THERE ANY MARKING OR UNEVENNESS ON THE TAPERED EDGE OF THE LINER? SURGEON SAID THAT THERE MAY HAVE BEEN SOMETHING ON IT, BUT IT DISAPPEARED DUE TO WEAR.

  Patient problems: Foreign Body Reaction; Osteolysis

  MAUDE report 12891214 ↗
• InjuryJan 4, 2021Noise, Audible; Noise, Audible

  REVISION SURGERY DONE. SURGEON REPORTED THE PATIENT WAS EXPERIENCING "SCRUNCHING" AND "SQUEAKING".

  Patient problems: No Information

  MAUDE report 11113721 ↗
• MalfunctionMar 19, 2020Noise, Audible; Noise, Audible

  WHILE CONVERSING WITH A SURGEON REGARDING A PATIENT WITH AN ALLEGED KNEE CONSTRUCT WITH SQUEAKING, THE SURGEON SENT THE FOLLOWING MESSAGE: "JUST RECEIVED THE IMPLANT STICKERS OF THE RIGHT HIP REPLACEMENT OF THE PATIENT WITH THE SQUEAKING. SHE DOES HAVE A CERAMIC ON CERAMIC HIP REPLACEMENT WHICH COULD BE THE SOURCE OF THE SQUEAKING." IMPLANT STICKERS OF THE HIP, IMPLANTED IN 2005, ARE PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9857600 ↗
• InjuryMay 21, 2019Break; Degraded; Fracture; Break; Degraded; Fracture

  A HOSPITAL REPRESENTATIVE REPORTED THE FOLLOWING EVENT : "WE RECEIVED A DECLARATION OF MATERIAL VIGILANCE FROM THE ORTHOPAEDIC BLOCK OF OUR INSTITUTION, WHICH HAD TO INTERVENE TO CHANGE A TRIDENT CERAMIC INSERT IN A PATIENT WHO HAD BEEN WEARING A HIP REPLACEMENT FOR 13 YEARS. IT IS AN IMPLANT OF REFERENCE 625-0T-28D AND LOT NUMBER U5570402 OR 433475G CERAMIC INSERT BROKEN INSIDE THE LINER OF THE COTYLE. PRESENCE OF METALOSIS" UPDATE: 10 JULY 2019. AS PER MEDICAL REVIEW "CUP MALPOSITION IN EXCESSIVE INCLINATION OF 66° HAS CONTRIBUTED TO AN OVERLOAD CONDITION IN THE ARTHROPLASTY BEARING RESULTING IN A CERAMIC LINER FRACTURE AFTER 13 YEARS REQUIRING REVISION SURGERY. ALSO FROM MEDICAL REVIEW "THE REPORTED METALLOSIS IS SECONDARY TO CONTACT OF THE CERAMIC FEMORAL HEAD WITH THE METAL OF THE CUP SHELL AFTER BEARING FRACTURE."

  Patient problems: Inflammation; Injury; Reaction

  MAUDE report 8629398 ↗
• InjuryMay 15, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT'S RIGHT HIP REPLACEMENT WAS DONE ON (B)(6) 2018. PATIENT HAD A DISLOCATION ON (B)(6) 2018 AND AFTER CLOSED REDUCTION WAS DONE, PATIENT'S HIP DISLOCATED AGAIN AND ANOTHER CLOSED REDUCTION WAS DONE THE SAME DAY ((B)(6) 2018). PATIENT WAS REVISED TO STRYKER DEVICES ON (B)(6) 2019 DUE TO INSTABILITY. THIS PI IS FOR CLOSED REDUCTION (2) DONE ON (B)(6) 2018.

  Patient problems: Injury; Joint Dislocation

  MAUDE report 8612750 ↗
• InjuryJan 21, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT: PATIENT HAS BILATERAL HIP IMPLANTS. RIGHT HIP SURGERY WAS DONE ON (B)(6) 2003 AND PATIENT HAS NO COMPLAINTS. HER LEFT HIP SURGERY WAS DONE ON (B)(6) 2003. PATIENT SAID THAT SHE HAS PAIN IN THE LEFT HIP, BACK AND KNEE SINCE (B)(6) 2011. SHE HAD TWO MRIS AND A CAT SCAN THAT SHOWED A HEMATOMA IN THE LEFT HIP IMPLANTS. WHEN SEEN ON (B)(6) 2011, SHE NOTED PAIN IN THE LEFT HIP SINCE (B)(6) 2011 AND WAS TOLD SHE HAD A HEMATOMA IN THE LEFT GROIN. SHE "HAD SURGERY TO REMOVE IT ... TOLD METAL FROM TOTAL HIP EXPOSED AND SHOULD SEE AN ORTHOPAEDIST ... CURRENTLY HAS WOUND VAC ... WOUND LEFT OPEN BY SURGEON". THIS PI IS FOR THE REMOVAL OF THE FIRST HEMATOMA (LEFT HIP).

  Patient problems: Hematoma; Pain

  MAUDE report 8264497 ↗
• InjuryJan 21, 2019Degraded; Mechanical Problem; Degraded; Mechanical Problem

  "ON (B)(6) 2012 SHE NOTED "PAIN FOR FIVE MONTHS ... TOLD HEMATOMA RETURNED". MRI SHOWED "POSSIBLE METALLOSIS". [...] DURING THE LEFT HIP REVISION SURGERY, "AT SURGERY AN IMPINGEMENT OF THE TITANIUM NECK ON THE ACETABULAR RIM WITH METALLOSIS IN THE JOINT AND ANTERIOR CYST "LIKELY DUE TO METALLOSIS" WAS NOTED." UPDATE 17-JAN-2019: MEDICAL REVIEW CLARIFIED THAT TRITANIUM NECK IMPINGED ON THE METAL RIM OF THE CERAMIC INSERT.

  Patient problems: Hematoma; Inflammation; Injury; Pain; Reaction

  MAUDE report 8264408 ↗
• MalfunctionSep 4, 2018Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  DURING A HIP REPLACEMENT OPERATION, THE SURGEON FOUND THAT THE TRIDENT ALUMINA INSERT WAS PROPERLY INSTALLED, BUT THE TRIDENT ALUMINA INSERT CAN¿T FIXED WITH TRIDENT HEMISPHERICAL CLUSTER AND VERY EASY FELL OFF.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7844055 ↗

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.