MRS 6485-3-113Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07613327048377), received between Jun 25, 2018 and Jun 14, 2023 — classified as 5 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 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.

• InjuryJun 14, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  POSTOPERATIVELY, THE GMRS DISTAL FEMORAL COMPONENT WAS DISLODGED FROM THE STEM. UPDATE: " AS FOR THE POSTOPERATIVE COURSE, CLEANSING DEBRIDEMENT WAS PERFORMED UNDER LOCAL ANESTHESIA FOR SUPERFICIAL INFECTION OF THE POSTOPERATIVE WOUND. AFTER THAT, THE PATIENT FELL AND THE WOUND WAS OPENED AGAIN AND THE WOUND WAS RE-SUTURED. WHEELCHAIR SELF-PROPELLED AND DISCHARGED. AT THE END OF (B)(6) 2023, THE PATIENT HAD RIGHT KNEE PAIN WHEN TAKING A SHOWER AND WHEN SHE UNDERWENT AN EXAMINATION IN MAY, IT WAS CONFIRMED THAT THE IMPLANT HAD FALLEN OUT. IN ADDITION, RECURRENCE OF OSTEOSARCOMA WAS RECOGNIZED FROM THE TISSUE DURING REVISION SURGERY."

  Patient problems: Insufficient Information; Pain

  MAUDE report 17123933 ↗
• InjuryJul 7, 2020Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THAT A STAGE 1 REVISION WAS PERFORMED ON THE PATIENT'S LEFT KNEE DUE TO ELEVATED TITANIUM IONS. INTRA-OPERATIVELY, SURGEON REPORTED THAT THE TITANIUM FEMORAL STEM WAS LOOSE. THE PATIENT'S ENTIRE MRH CONSTRUCT WAS REMOVED AND A SPACER WAS PLACED. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED.

  Patient problems: Inflammation; Injury; Reaction

  MAUDE report 10239480 ↗
• InjuryFeb 11, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  ITS REPORTED BY THE ATTORNEY, THROUGH THE FILING OF A LEGAL CLAIM, THAT THE PATIENT UNDERWENT KNEE SURGERY ON (B)(6) 2016 DUE TO A FRACTURED LEFT PROXIMAL TIBIAL ALLOGRAFT, CATASTROPHIC FAILURE, LEFT ALLOPROSTHETIC ARTHROPLASTY. IT'S FURTHER ALLEGED THAT THE PATIENT UNDERWENT ONE STAGE LEFT KNEE ENDOPROSTHETIC REVISION, RADICAL SYNOVECTOMY ON (B)(6) 2019 DUE TO INFECTION.

  Patient problems: Inflammation; Injury; Reaction; Unspecified Infection

  MAUDE report 9696417 ↗
• InjuryOct 16, 2019Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THE PATIENT'S LEFT KNEE WAS REVISED. AS REPORTED BY REP: "PATIENT PRESENTED WITH THIGH PAIN, IT WAS DETERMINED THE PREVIOUS STEM WAS LOOSE DUE TO ASEPTIC LOOSENING. THE GROWING DISTAL FEMUR CONSTRUCT WAS REMOVED AND THE DISTAL FEMUR REVISED. ALL COMPONENTS EXCEPT THE MRH TIBIA BASEPLATE AND STEM EXTENDER WERE REPLACED." REP PROVIDED USAGE SHEETS FROM CURRENT AND PREVIOUS PROCEDURES AND REPORTED THAT NO FURTHER INFORMATION WILL BE AVAILABLE.

  Patient problems: Inadequate Osseointegration; Injury; Pain

  MAUDE report 9197472 ↗
• InjuryJun 25, 2018Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THAT PATIENT'S HIP WAS REVISED DUE TO A LOOSE STEM.

  Patient problems: Inadequate Osseointegration; Injury

  MAUDE report 7635440 ↗