Trident 502-01-54ERecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07613153073093), received between Jan 2, 2019 and May 28, 2019 — classified as 3 injuries, 1 malfunction.

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

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.

• InjuryMay 28, 2019Osseointegration Problem; Osseointegration Problem

  THE FOLLOWING REVISION EVENT WAS INCLUDED IN A REPORT RECEIVED AS PART OF THE (B)(6) IIS: PATIENT HAD A RIGHT PRIMARY THA DUE TO OSTEONECROSIS; UNDERWENT REVISION DUE TO INFECTED THA AND ACETABULAR LOOSENING; ALL COMPONENTS REVISED. PATIENT'S BMI IS REPORTED AS 35.5.

  Patient problems: Inadequate Osseointegration; Injury; Unspecified Infection

  MAUDE report 8645265 ↗
• InjuryMar 12, 2019Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED DUE TO ASEPTIC LOOSENING OF THE SHELL. A 54E SHELL, POLY LINER, AND 36 +0 LFIT V40 HEAD WERE REVISED TO A TRIDENT REVISION SHELL, 36 LINER, AND 36 BIOLOX CERAMIC HEAD. REP CONFIRMED THAT NO ALLEGATIONS AGAINST THE LINER OR THE HEAD WERE REPORTED BY THE SURGEON OR ANY DOCUMENTATION SEEN. REP REPORTED THAT X-RAYS, MEDICAL RECORDS, AND ADDITIONAL INFORMATION ARE NOT AVAILABLE.

  Patient problems: Inadequate Osseointegration; Injury

  MAUDE report 8412225 ↗
• InjuryFeb 5, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT HAD A TOTAL HIP IN 2007 AND PRESENTED WITH RECENT HIP PAIN WITH X-RAYS INDICATING LYSIS AROUND THE SCREW IN THE CUP. UPDATE 11/JANUARY/2019: AS REPORTED IN ADVERSE CONSEQUENCE DETAILS: "PATIENT REQUIRED REVISION OF THE CUP WITH ADAPTOR SLEEVE AND CERAMIC HEAD". SPOKE TO REP. A STRYKER SCREW WAS ALSO REVISED. REP REPORTED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Injury; Osteolysis; Pain

  MAUDE report 8304961 ↗
• MalfunctionJan 2, 2019Use of Device Problem; Malposition of Device; Use of Device Problem; Malposition of Device

  EXETER STEM BROKE 1.5 YEARS AFTER IMPLANTATION. X-RAY ATTACHED. MEDICAL REVIEW COMPLETED ON (B)(6) 2018 STATES; {...} A REVIEW OF THE PROVIDED MEDICAL RECORDS AND X-RAYS BY A CLINICAL CONSULTANT INDICATED: {...} CUP MALPOSITION IN LOW INCLINATION WITH LACK OF ANTEVERSION AND A MEDIALIZED LOWER CUP RIM IN THE ACETABULAR BONE IN COMBINATION WITH INAPPROPRIATE USE OF AN OFFSET CUP LINER AND USE OF A SKIRTED FEMORAL HEAD IN A MORBIDLY OBESE PATIENT HAVE CONTRIBUTED TO AN OVERLOAD CONDITION IN THE ARTHROPLASTY WITH FATIGUE ACCUMULATION AND ULTIMATELY A FATIGUE FRACTURE OF THE EXETER STEM NECK EXACTLY AT THE LEVEL OF PEAK OVERLOAD. {...}.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8209648 ↗