Accolade 6720-0230Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04546540664457), received between Feb 19, 2019 and Dec 9, 2024 — classified as 5 injuries.

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.

• InjuryDec 9, 2024Fracture; Adverse Event Without Identified Device or Use Problem; Fracture; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS REPORTED: AFTER FAILURE OF THE PREVIOUSLY INSERTED STRYKER STEM FOLLOWING TUMOR RESECTION WITH HEMIPELVECTOMY, A REVISION WAS INDICATED.

  Patient problems: Insufficient Information

  MAUDE report 20880012 ↗
• InjuryNov 30, 2021Loss of Osseointegration; Loss of Osseointegration

  ON (B)(6) 2013 PRIMARY SURGERY. ON (B)(6) 2019 X-RAY SHOWED RADIOLUCENT LINE AROUND RIGHT GREATER TROCHANTER. ON (B)(6) 2020 X-RAY SHOWED CLEARER RADIOLUCENT LINE AROUND RIGHT GREATER TROCHANTER. ON (B)(6) 2020 X-RAY SHOWED CLEARER RADIOLUCENT LINE AROUND RIGHT GREATER TROCHANTER AND BEHIND INTERTROCHANTER. NO INFECTION. ON (B)(6) 2021 REVISION SURGERY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 12904797 ↗
• InjuryOct 8, 2019Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS REPORTED THROUGH THE FILING OF A LAWSUIT THAT ALLEGEDLY THE PATIENT WAS IMPLANTED WAS IMPLANTED WITH AN LFIT ANATOMIC COCR V40 FEMORAL HEAD ON HER RIGHT HIP ON OR ABOUT (B)(6) 2016 AND WAS REVISED ON (B)(6) 2016. IT IS FURTHER ALLEGED THAT SHE SUFFERED INJURIES AS A RESULT OF IMPLANTATION AND EXPLANTATION OF THE DEVICE AT ISSUE AND EXCESSIVE LEVELS OF CHROMIUM AND COBALT IN HER BLOOD.

  Patient problems: Inflammation; Injury; Metal Related Pathology; Reaction

  MAUDE report 9165815 ↗
• InjuryMay 13, 2019Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED AFTER PATIENT COMPLAINT OF PAIN. SURGEON REPORTED THAT THE SHELL LOOSENED AND LOOKED RETROVERTED. INTRA-OPERATIVELY, IT WAS FOUND THAT THE EDGE OF THE SHELL IMPINGED ON THE STEM AND NOTCHED IT, AND THE SURGEON REPORTED THE PRESENCE OF METALLOSIS. THE SHELL AND LINER WERE REVISED, THE STEM AND HEAD WERE RETAINED. THERE ARE NO ALLEGATIONS AGAINST THE LINER (NO WEAR, DISCOLORATION, ETC). PATIENT WAS REVISED TO A TRITANIUM II SHELL AND MDM/ADM LINER CONSTRUCT. REP REPORTED THAT NO FURTHER INFORMATION WILL BE AVAILABLE. UPDATE 16/APRIL/2019: REP WAS ABLE TO PROVIDE A PRE-REVISION X-RAY AND AN INTRA-OPERATIVE PHOTO AND RE-CONFIRMED THAT NO FURTHER INFORMATION WOULD BE AVAILABLE.

  Patient problems: Inadequate Osseointegration; Injury; Pain

  MAUDE report 8606052 ↗
• InjuryFeb 19, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  POSTOPERATIVE DIAGNOSIS: PATIENT UNDERWENT LEFT HIP HEMI ARTHROPLASTY FOR FEMORAL NECK FRACTURE (B)(6) 2014. PATIENT RETURNED TO HAVE REVISION ARTHROPLASTY WITH INSERTION OF ANTIBIOTIC BEADS FOR HIP INFECTION (B)(6) 2014. ALL COMPONENTS EXCHANGED.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 8352331 ↗