Trident 542-11-58GRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 07613327037319), received between Dec 26, 2018 and May 15, 2023 — classified as 7 injuries.

The most frequently reported specific device problem is “Fracture” (2 reports).

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.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryMay 15, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  THE PATIENT HAD PREVIOUSLY HAD HIS PRIMARY HIP REPLACEMENT REVISED, A STANDARD TRIDENT INSERT AND 32MM FEMORAL HEAD WERE EXPLANTED AND A TRIDENT CONSTRAINED INSERT AND 28MM VITALLIUM FEMORAL HEAD WERE IMPLANTED. REASON FOR THIS REVISION YESTERDAY WAS THAT THE CONSTRAINED INSERT HAD DISLOCATED. THE PATIENT REPORTED TO HOSPITAL AS THE HIP PROSTHESIS IN-SITU HAD DISLOCATED. THE WHOLE TRIDENT CONSTRAINED INSERT HAD DISLOCATED FROM THE TRIDENT SHELL, AND THEN SOMEHOW THE BIPOLAR HEAD HAD DISLOCATED FROM THE INSERT THAT IT HAD BEEN PRE-ASSEMBLED IN. THE BIPOLAR HEAD STILL HAD THE FEMORAL HEAD WITHIN IT, WHICH ITSELF WAS STILL INTACT ON THE ACCOLADE STEM TRUNNION.

  Patient problems: Insufficient Information; Joint Dislocation

  MAUDE report 16930319 ↗
• InjuryMar 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ORIGINAL TOTAL HIP REPLACEMENT (B)(6) 2010 PATIENT HAD ACETABULAR COMPONENTS AND FEMORAL HEAD REMOVED AND REPLACED WITH TRITANIUM SHELL AND MDM LINER SURGEON RECORDED OSTEOLYSIS AS REASON FOR REVISION ON JOINT REGISTRY FORM. LEFT SIDE.

  Patient problems: Osteolysis

  MAUDE report 13925265 ↗
• InjuryDec 8, 2021Malposition of Device; Malposition of Device

  AS PER RECORDS RECEIVED, "ACCORDING TO THE (B)(6) 2019 REVISION OPERATIVE REPORT, HE HAD PERSISTENT PAIN AND WAS REVISED 5 YEARS AGO. AT SURGERY HIS ACETABULAR COMPONENT WAS FOUND TO BE IN RETROVERSION. A NEW STRYKER ACETABULAR COMPONENT WAS PLACED ALONG WITH NEW STRYKER HEAD ON HIS ACCOLADE STEM."

  Patient problems: Pain

  MAUDE report 12965469 ↗
• InjuryFeb 27, 2020Fracture; Fracture

  THE CUSTOMER REPORTED THAT : "THE TRIDENT RIGHT HIP PROSTHESIS WAS PLACED THE (B)(6) 2007 WITH THE IMPLANTS PROTHEOS. ON (B)(6) 2020 WE PROCEEDED TO CHANGE THE HEAD AND THE INSERT BECAUSE IT BROKE."

  Patient problems: Injury

  MAUDE report 9763354 ↗
• InjuryJun 24, 2019Crack; Fracture; Crack; Fracture

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED AFTER PATIENT COMPLAINT OF PAIN. INTRA- OPERATIVELY, BLACK TISSUE AND CERAMIC FRAGMENTS WERE NOTED, AND NO CERAMIC WAS INSIDE OF THE ALUMINA INSERT. THE SHELL, 2 SCREWS, ALUMINA LINER AND ALUMINA HEAD WERE REVISED. REP PROVIDED A PRIMARY OPERATIVE REPORT AND IMPLANT SHEET, PRE-REVISION X-RAYS, AND EXPLANT PICTURES.

  Patient problems: Device Embedded In Tissue or Plaque; Injury; Reaction

  MAUDE report 8727913 ↗
• InjuryApr 30, 2019Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO SHELL LOOSENING. A TRIDENT PSL HA CLUSTER SHELL AND MDM/ ADM LINER CONSTRUCT WERE REVISED. REP REPORTED THAT NO FURTHER INFORMATION WILL BE RELEASED.

  Patient problems: Inadequate Osseointegration; Injury

  MAUDE report 8565632 ↗
• InjuryDec 26, 2018Degraded; Degraded

  AN 88-YEAR-OLD MAN, BMI 24, PRESENTED TO THE CLINIC WITH COMPLAINTS OF PAIN AND A CRACKING SENSATION IN HIS RIGHT HIP APPROXIMATELY SIX MONTHS, NINE YEARS POST PRIMARY RIGHT THA. DURING THE INITIAL PROCEDURE, THE PRIMARY COMPONENTS UTILIZED AN ACCOLADE #3 STEM WITH A 127-DEGREE NECK-SHAFT ANGLE AND +5 36MM L-FIT HEAD. RADIOGRAPHIC IMAGES OF THE RIGHT HIP SHOWED AN APPARENT TRUNNION FRACTURE WITH SIGNIFICANT ASYMMETRIC WEAR OF THE POLYETHYLENE LINER WITHIN THE ACETABULAR COMPONENT. PREOPERATIVE BLOODWORK REVEALED NORMAL LEUKOCYTES AND NORMAL-RANGE C-REACTIVE PROTEIN (CRP) AND ERYTHROCYTE SEDIMENTATION RATE (ESR). THUS, THE PATIENT WAS CONSENTED FOR REVISION THA FOR A PRESUMED TRUNNION FRACTURE. INTRAOPERATIVE ASSESSMENT REVEALED MARKED HETEROTOPIC OSSIFICATION ALONG THE GREATER TROCHANTER OF THE RIGHT FEMUR, EXTENDING INTO THE GLUTEUS MAXIMUS, WHICH WAS EXCISED AND DEBRIDED THOROUGHLY. THOUGH THE FEMORAL HEAD WAS INTACT AND SHOWED NO GROSS SIGNS OF WEAR, THERE WAS COMPLETE DISSOCIATION FROM THE FEMORAL STEM. THERE WERE ALSO SIGNIFICANT SIGNS OF METALLOSIS WITH METAL-STAINED DEBRIS AND GRANULATION TISSUE, WHICH EXTENDED DEEP TO THE MARGINS SURROUNDING THE ACETABULAR SHELL. INTERESTIN

  Patient problems: Inflammation; Pain; Unspecified Infection

  MAUDE report 8195958 ↗