Accolade 6058-0435DRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07613327020731), received between Jul 7, 2017 and Aug 19, 2021 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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. 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryAug 19, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  BIPOLAR HEAD DISASSOCIATED FROM STEM AND FEMORAL HEAD CONSTRUCT DURING A WATER SKIING FALL. UPDATE: THE PATIENT WAS REVISED ON (B)(6) 2021.

  Patient problems: Discomfort

  MAUDE report 12345677 ↗
• InjuryJun 12, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT'S HIP WAS REVISED DUE TO INFECTION. AN ACCOLADE C STEM, UNITRAX HEAD AND SLEEVE WERE REVISED TO A RESTORATION MODULAR STEM, BIOLOX HEAD, ADM/MDM INSERT WITH MDM LINER, A SHELL, AND SCREWS. REP REPORTED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 10147699 ↗
• InjuryFeb 4, 2019Osseointegration Problem; Osseointegration Problem

  "REASON FOR EVENT: ORIGINAL SHELL WAS [IMPLANTED] VERTICALLY. OVER TIME, POLY WEAR MAY HAVE CAUSED AN OSTEOLYTIC RESPONSE AND LOOSENED STEM. SURGERY: SURGEON REMOVED [ACCOLADE CEMENTED STEM, OMNIFIT DISTAL SPACER, BIOLOX 36 -2.5 HEAD, 36F X3 0° LINER, 58F TRITANIUM HEMISPHERICAL CLUSTER HOLE SHELL, AND 2 SCREWS] AND REPLACED WITH A NEW [STRYKER SHELL, LINER, HEAD] AND RESTORATION MODULAR STEM. CUP AND STEM WELL POSITIONED - PATIENT STABLE. SURGEON REPORTED THE SHELL HAD INITIALLY BEEN IMPLANTED IN A VERTICAL POSITION, THE SHELL DID NOT MOVE BUT DID CONTRIBUTE TO LINER WEAR.

  Patient problems: Inadequate Osseointegration; Injury

  MAUDE report 8302366 ↗
• MalfunctionApr 12, 2018Break; Break

  AS REPORTED IN (B)(4): "THE STEM END-CAP BROKE WHILE BEING SECURED INTO THE FEMORAL STEM". ORIGINALLY INTENDED PROCEDURE: "ARTHROPLASTY OF THE [HIP], THE PART OF THE PROSTHESIS THAT INSERTS INTO THE END OF THE TRIMMED AND PREPARED FEMUR".

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7427073 ↗
• InjuryJul 7, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  DURING THE SURGERY THE CEMENT DID NOT SET UP PROPERLY, IT WAS REMOVED FROM THE CANAL, ANOTHER BATCH WAS MIXED AND USED. UPON THE IMPLANTATION OF THE SECOND STEM THE FEMUR WAS FRACTURED.

  Patient problems: Bone Fracture(s)

  MAUDE report 6694471 ↗