Secur-Fit J6054-0711Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04546540003072), received between Apr 29, 2020 and Apr 29, 2020 — classified as 1 injury.

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

• InjuryApr 29, 2020Corroded; Insufficient Device Problem Information; Corroded; Insufficient Device Problem Information

  AT THE PRIMARY "THA" ON (B)(6) 2012, SUPER SECURE FIT PLUS AND METAL HEAD V40 TAPER 36MM + 5 WERE USED. ARMD SUSPECTED, HEAD AND LINER REPLACEMENT OPERATION PERFORMED ON (B)(6) 2020. WHEN THE HEAD WAS REMOVED FROM THE STEM, DARKENING WAS OBSERVED ON THE STEM TRUNNION AND INSIDE THE HEAD. FROM THE SURROUNDING SOFT TISSUE, THERE WAS SOMETHING LIKE A PSEUDOTUMOR, WHICH WAS REMOVED AS MUCH AS POSSIBLE. AFTER INSTALLING THE NEW LINER, THE STEM WAS DIFFICULT TO REMOVE, SO WE KEPT A NEW TITANIUM SLEEVE ON THE TRUNNION AND HAMMERED THE DELTA CERAMIC HEAD. THE SLEEVE AND DELTA CERAMIC HEAD WERE CONFIRMED TO BE LOCKED TO THE STEM TRUNNION. INVESTIGATE WHAT THE DARKENING INSIDE THE REMOVED HEAD IS, WHETHER IT IS CORROSION OR METAL WEAR.

  Patient problems: Inflammation; Injury; Reaction

  MAUDE report 10011969 ↗