Accolade 6720-0127Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04546540664440), received between Oct 21, 2019 and Apr 13, 2020 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 13, 2020Inadequacy of Device Shape and/or Size; Insufficient Device Problem Information; Inadequacy of Device Shape and/or Size; Insufficient Device Problem Information

  THIS IS TO BRING YOUR NOTICE THAT THERE WAS A SURGERY FOR THR ON (B)(6) 2020. DURING THE SURGERY INITIALLY DR DECIDED TO USE ACCOLADE II(SIZE 1) WITH CERAMIC HEAD. BUT UNFORTUNATELY THE CERAMIC HEAD DID NOT FIT WELL WITH OUR STEM AND IT WAS COMING OUT EVERY TIME HE WAS TRYING TO FIT. DR FOUND SO MANY SCRATCHES INSIDE THE CERAMIC HEAD. SO HE DECIDED TO USE METAL HEAD BUT THE METAL HEAD ALSO DID NOT FIT WITH THE STEM. SO FINALLY DR REPLACED THE STEM TO ACCOLADE II(SIZE 2) AND TRIED WITH METAL HEAD AND IT FITTED WELL. DURING THE SURGERY DR ANALYZED THAT THE TAPPER SIZE OF ACCOLADE II(SIZE 1) WAS NOT CORRECT AND I.E BOTH THE HEAD DID NOT FIT WELL. SO REQUESTING YOU PLEASE SUGGEST HOW TO GO AHEAD AS THE DEALER IS HAVING TWO UNUSED IMPLANTS(1-ACCOLADE II SIZE 1,2-CERAMIC HEAD) WHICH WAS OPENED INSIDE OT. I AM ATTACHING THE PHOTOGRAPHS AND PRODUCT ENQUIRY INTAKE FORM FOR YOUR REFERENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9954278 ↗
• InjuryOct 21, 2019Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THE PATIENT'S RIGHT HIP WAS REVISED DUE TO FEMORAL STEM LOOSENING. THE ACCOLADE II STEM AND LFIT V40 FEMORAL HEAD WERE REVISED TO A RESTORATION MODULAR STEM CONSTRUCT WITH A CERAMIC HEAD. REP CONFIRMED THAT THERE ARE NO ALLEGATIONS AGAINST THE HEAD. THE LINER WAS NOT REVISED. THE EXPLANTS ARE ALLEGEDLY AVAILABLE FOR RETURN. REP PROVIDED AN EXPLANT PICTURE AND REPORTED THAT NO FURTHER INFORMATION WILL BE AVAILABLE.

  Patient problems: Inadequate Osseointegration; Injury

  MAUDE report 9216236 ↗