MRS 6485-3-013Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07613327048315), received between Jan 12, 2021 and Jul 23, 2024 — classified as 4 injuries.

The most frequently reported specific device problem is “Loss of Osseointegration” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJul 23, 2024Corroded; Corroded

  IT WAS REPORTED THE PATIENT'S LEFT KNEE WAS REVISED DUE TO COMPLAINT OF PAIN. ORIGINAL PLAN WAS TO RESURFACE THE PATIENT'S NATIVE PATELLA. THOUGH PATIENT WAS NEGATIVE FOR INFECTION, SURGEON DECIDED TO REVISE THE DISTAL FEMORAL COMPONENT, STEM AND EXTENDER OUT OF AN ABUNDANCE OF CAUTION. WHEN THE DEVICES WERE DISSOCIATED, CORROSION WAS NOTED AT THE JUNCTION OF THE DISTAL FEMUR AND EXTENSION AND THE JUNCTION OF THE EXTENSION AND STEM. REP CAN PROVIDE PICTURES AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Pain

  MAUDE report 19806104 ↗
• InjuryJul 31, 2023Loss of Osseointegration; Loss of Osseointegration

  LEFT DISTAL FEMUR 1ST STAGE REVISION SURGERY ABOVE KNEE CAST DUE TO ASEPTIC LOOSENING OF THE FEMUR STEM. WIDE FEMUR MEDULLARY CANAL MORE THAT 17MM- NEED CUSTOM MADE STEM.

  Patient problems: Inadequate Osseointegration

  MAUDE report 17422685 ↗
• InjuryJul 17, 2023Failure to Osseointegrate; Loss of Osseointegration; Failure to Osseointegrate; Loss of Osseointegration

  A PATIENT-SPECIFIC IMPLANT PRESCRIPTION WAS RECEIVED FOR THE PATIENT'S LEFT GMRS DISTAL FEMUR. NOTED ON THE FORM: "LOOSENING STEM." AS AN FIRST STAGE OF REVISION, CEMENT SPACER FIXED. UPDATE: PATIENT WAS UNDERWENT STAGE 1 OF A LEFT DISTAL FEMUR REVISION ON (B)(6) 2023 DUE TO ASEPTIC LOOSENING OF THE FEMUR STEM. THE FEMORAL COMPONENTS WERE EXPLANTED AND THE PATIENT WAS CLOSED BACK UP WITH A CEMENT SPACER AND ABOVE THE KNEE CAST APPLIED AS THE SURGEON REQUIRES A CUSTOM DEVICE TO ACCOMMODATE THE PATIENT'S WIDE FEMUR MEDULLARY CANAL OF MORE THAT 17MM. THE SECOND STAGE OF THIS REVISION WAS REPORTED TO BE PLANNED FOR (B)(6) 2023 DURING WHICH THE CUSTOM FEMORAL IMPLANT WOULD BE IMPLANTED.

  Patient problems: Inadequate Osseointegration

  MAUDE report 17339701 ↗
• InjuryJan 12, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "PT. PREVIOUSLY RECEIVED A GMRS DISTAL-FEMUR REPLACEMENT ((B)(6) 2018) AND PRESENTED THIS WEEK WITH A PERIPROSTHETIC FRACTURE PROXIMAL TO IM STEM. THE DISTAL FEMUR WAS REVISED TO A TOTAL-FEMUR CONSTRUCT. ALL OTHER DISTAL-FEMUR COMPONENTS IMPLANTED ON (B)(6) 2018 WERE RETAINED." SPOKE TO REP, WHO PROVIDED THE PRIMARY AND REVISION USAGE SHEETS. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Bone Fracture(s)

  MAUDE report 11153269 ↗