Trident 540-01-52ERecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04546540080790), received between Aug 20, 2018 and Aug 20, 2018 — classified as 1 injury.

The most frequently reported specific device problem is “Material Disintegration” (1 report).

1 other recall cover devices cleared under the same FDA submission (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.

• InjuryAug 20, 2018Material Disintegration; Material Disintegration

  CONDITION AFTER IMPLANTATION OF AN ACCOLADE SHAFT WITH V40 HEAD, DEVELOPMENT OF A LARGE PSEUDOTUMOR IN THE GROIN AREA DUE TO KNOWN CONE PROBLEMS IN THIS IMPLANT COMBINATION. SURGEON FORWARDED US THE FOLLOWING INFORMATION: IN SUMMARY, THE INCIDENT IS THE FOLLOWING SITUATION: PATIENT (B)(6), (B)(6) YEARS, CURRENTLY 178 CM HEIGHT AND (B)(6) KG BODY WEIGHT. ANAMNESE: ON 2007 IMPLANTATION OF A CEMENTLESS HIP ENDOPROSTHESIS (ACCOLADE, TRIDENT, METAL HEAD -0.5, ARTICLE NUMBERS ACCORDING TO ATTACHED SURGICAL REPORT). DEVELOPMENT OF LOCAL METAL INTOLERANCE WITH LARGE "PSEUDOTUMOR" / ARMD IN THE LEFT HIP WITH COMPRESSION OF THE ILIAC VEIN PRESUMABLY IN THE YEARS 2014 TO 2107 OF INCREASING SIZE. CURRENTLY 2017/2018 INCREASING LOCAL DISCOMFORT IN THE LEFT HIP JOINT. METAL VALUE INCREASE WITH COBALT IN WHOLE BLOOD 6,89 UG / L (REFERENCE RANGE 0,5-3,9 UG/ L) AT NORMAL CHROMIUM VALUES (0,62 UG/ L AT REFERENCE VALUE 0,5 TO 4,0 UG/ L IN WHOLE BLOOD ). X-RAY INCREASING OSTEOLYSIS IN THE CUP AREA, IN CT AND MRI, FORMATION OF A LARGE PSEUDOTUMOR BOTH IN THE AREA OF THE OUTSIDE HIP MUSCLES AND IN THE RETROPERITONEUM AROUND THE ILIACUS MUSCLE. DUE TO INCREASING COMPLAINTS, THE RESECTION OF THE PSEUDOTUM

  Patient problems: Discomfort; Edema; Injury; Osteolysis; Reaction

  MAUDE report 7798845 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under 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)