Accolade 6020-5537Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04546540510648), received between Jul 18, 2019 and Jun 8, 2022 — classified as 5 injuries.

The most frequently reported specific device problem is “Material Erosion” (3 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 18, 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.

• InjuryJun 8, 2022Material Erosion; Material Erosion

  IT WAS REPORTED BY PATIENT'S ATTORNEY THAT ALLEGEDLY ON OR ABOUT MARCH 11, 2011, THE PATIENT WAS IMPLANTED WITH AN LFIT ANATOMIC COCR V40 FEMORAL HEAD ON HIS RIGHT HIP AND HAS HAD INCREASING PAIN AND ELEVATED COBALT AND CHROMIUM SERUM LEVELS. DURING THE REVISION SURGERY ON (B)(6) 2022, THE SURGEON NOTED THAT "THE FEMORAL HEAD CAME OFF THE TRUNNION SIMPLY BY PULLING ON IT BY HAND. THE TRUNNION WAS NOTED TO BE WORN OR PENCILED GROSSLY."

  Patient problems: Foreign Body Reaction

  MAUDE report 14632662 ↗
• InjuryJul 15, 2021Degraded; Detachment of Device or Device Component; Degraded; Detachment of Device or Device Component

  IT WAS REPORTED THAT ON (B)(6) 2021 WHILE WALKING THE PATIENT HEARD A POP AND A CLICK AND BEGAN TO FEEL PAIN. THE PATIENT THEN PRESENTED TO THE ER AND IT WAS DISCOVERED THAT THE HEAD POPPED OFF THE TRUNNION THEREFORE A REVISION HIP SURGERY WAS REQUIRED. TOTAL LEFT SIDE HIP REVISION WAS PERFORMED ON (B)(6) 2021.

  Patient problems: Pain

  MAUDE report 12171681 ↗
• InjuryMar 13, 2020Material Erosion; Material Erosion

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED. AS REPORTED BY REP: "X-RAY SHOWED A DISLOCATED STEM FROM THE HEAD AND WEAR ON THE STEM". THE PATIENT'S STEM, HEAD, AND LINER WERE REVISED.

  Patient problems: Injury

  MAUDE report 9828903 ↗
• InjuryJul 23, 2019Material Erosion; Fracture; Insufficient Device Problem Information; Material Erosion; Fracture; Insufficient Device Problem Information

  IT WAS REPORTED THROUGH THE FILING OF A LAWSUIT THAT ALLEGEDLY THE PATIENT WAS IMPLANTED WITH AN LFIT ANATOMIC COCR V40 FEMORAL HEAD ON HIS RIGHT HIP ON OR ABOUT (B)(6) 2005 AND WAS REVISED ON (B)(6) 2018. IT IS FURTHER ALLEGED THAT HE SUFFERED INJURIES AS A RESULT OF IMPLANTATION AND EXPLANTATION OF THE DEVICE AT ISSUE AND EXCESSIVE LEVELS OF CHROMIUM AND COBALT IN HIS BLOOD. UPDATE PER MEDICAL RECORDS RECEIVED ON 05-OCT-2023: "THE PATIENT IS AN 84-YEAR-OLD MALE WHO HAD HIP REPLACEMENT DONE NEARLY 20 YEARS AGO, HE SUSTAINED A FALL AND SUSTAINED A FRACTURE OF THE TRUNNION ON THE RIGHT HIP."

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

  MAUDE report 8816026 ↗
• InjuryJul 18, 2019Material Deformation; Material Deformation

  HEAD DISASSOCIATION AND TRUNION DISFIGURATION.

  Patient problems: Injury

  MAUDE report 8804532 ↗