Trident 500-11-54ERecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04546540431875), received between Dec 6, 2017 and Aug 14, 2019 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryAug 14, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT AFTER A RIGHT HIP REPLACEMENT IN 2011, PATIENT HAS BEEN EXPERIENCING PAIN SINCE THE FIRST YEAR THE IMPLANT WAS IN. SURGEON REPORTED A POTENTIAL PSEUDO-TUMOR AFTER TAKING MRI'S. PATIENT HAS NOT BEEN REVISED AS OF THE TIME OF REPORT. UPDATE ON 18 JUL 2019 BY QS: BASED ON THE PROVIDED MEDICAL RECORDS, THE REVISION SURGERY TOOK PLACE ON (B)(6) 2018. THE FOLLOWING INFORMATION IS ALSO NOTICED IN THE MEDICAL REVIEW: ¿ON (B)(6) 2014 STATES, ¿¿ CONTINUES TO DO WELL ¿ LEG LENGTH INEQUALITY FROM PRIOR HIP SURGERY MANY YEARS AGO; ¼¿ TO ½¿ SHORTER ON RIGHT¿ [¿]"ON (B)(6) 2018 AN OPERATIVE REPORT NOTES A PROCEDURE OF "1. RIGHT THA LIMITED REVISION FEMORAL HEAD AND POLY CHANGE; AND 2. RIGHT HIP EXCISION PSEUDO ACETABULUM, FOREIGN BODY GRANULOMA AND GANGLION CYST" FOR A PRE- AND POST- OPERATIVE DIAGNOSIS OF "(1) FAILED RIGHT TOTAL HIP ARTHROPLASTY SECONDARY TO TRUNNION METALLOSIS, POLYETHYLENE WEAR; AND (2) PSEUDO ACETABULUM WITH FOREIGN BODY GRANULATION AND GANGLION CYST FORMATION"." [...] "MODERATE ELEVATION OF ONE SERUM COBALT LEVEL AND NORMAL CHROMIUM LEVELS IN A PATIENT WITH BILATERAL TOTAL HIP ANGIOPLASTIES, ONE IN SITU EIGHTEEN YEARS AND THE OTHER SEVEN YEARS, IS NOT DI

  Patient problems: Inflammation; Injury; Pain; Reaction

  MAUDE report 8892377 ↗
• MalfunctionDec 6, 2017Scratched Material; Scratched Material

  IT WAS REPORTED THAT WHILE PERFORMING A PROCEDURE OF PATIENT'S LEFT HIP, THE CUP HAD SCRATCHES INSIDE. REP REPORTED THAT ALL PACKAGING WAS INTACT. THE REP TOOK A PHOTO OF THE IMPLANT AND CIRCLED THE AFFECTED AREA WITH MARKER. THE REP REPORTED THAT A BACKUP DEVICE WAS IMMEDIATELY AVAILABLE (NO SURGICAL DELAY).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7086258 ↗