MRS 6485-3-011Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 07613327048322), received between Jul 19, 2018 and Dec 11, 2025 — classified as 9 injuries.

The most frequently reported specific device problem is “Fracture” (5 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryDec 11, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT UNDERWENT LEFT HIP REVISION SURGERY. HALF A MONTH AGO, THE PATIENT SUDDENLY EXPERIENCED LEFT HIP PAIN WITH LIMITED MOBILITY WHILE USING THE TOILET AT HOME. ON (B)(6) 2025, DURING A FOLLOW-UP EXAMINATION AT THE LOCAL HOSPITAL, AN X-RAY WAS PERFORMED, DIAGNOSING "LEFT PROSTHETIC JOINT DISLOCATION." THE PATIENT WAS THEN ADMITTED TO OUR HOSPITAL FOR CLOSED REDUCTION UNDER ANESTHESIA, WITH GOOD POSTOPERATIVE RECOVERY.

  Patient problems: Joint Dislocation

  MAUDE report 23776174 ↗
• InjuryFeb 1, 2023Loss of Osseointegration; Loss of Osseointegration

  A PATIENT SPECIFIC IMPLANT REQUEST WAS RECEIVED FOR THE PATIENT'S RIGHT DISTAL FEMUR. NOTED ON THE FORM: "...S/P RESECTION AND RECONSTRUCTION RIGHT DISTAL FEMUR WITH STRYKER (B)(4) AND NOW SECOND EPISODE OF ASEPTIC LOOSENING... RETAINING 8MM LARGE ALL0POLY TIBIA." PROPOSED DATE OF SURGERY IS (B)(6) 2023.

  Patient problems: Inadequate Osseointegration

  MAUDE report 16276120 ↗
• InjurySep 26, 2022Fracture; Fracture

  GMRS DISTAL FEMUR MRS 11 X 127MM STEM BREAK.

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 15484836 ↗
• InjuryJul 5, 2022Fracture; Fracture

  IT WAS REPORTED BY A SURGEON THAT THE PATIENT HAD A BROKEN IMPLANT. THE PRIMARY SURGERY WAS COMPLETED ON (B)(6) 2007 AND THE FIRST REVISION SURGERY WAS COMPLETED ON (B)(6) 2017. THE BROKEN IMPLANT WAS FOUND ONE MONTH PRIOR TO THE SECOND REVISION SURGERY. THE SECOND REVISION SURGERY WAS COMPLETED ON (B)(6) 2022. THIS REPORT IS FOR THE SECOND REVISION.

  Patient problems: Ambulation or Postural Difficulties; Insufficient Information

  MAUDE report 14918073 ↗
• InjuryAug 24, 2021Osseointegration Problem; Osseointegration Problem

  AS REPORTED: "PT. PRESENTED WITH A LOOSE CEMENTED STEM OF A PREVIOUS [RIGHT] GMRS DISTAL-FEMUR REPLACEMENT ON (B)(6) 2020. DR REVISED THE FEMORAL COMPONENTS TO THE IMPLANTS ON THE SHEET BELOW." SPOKE TO REP: THERE ARE NO ALLEGATIONS AGAINST ANY OTHER DEVICES. NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Inadequate Osseointegration

  MAUDE report 12363356 ↗
• InjuryOct 7, 2020Fracture; Fracture

  THE FOLLOWING WAS REPORTED: FRACTURE OF GMRS STEM.

  Patient problems: Ambulation or Postural Difficulties; Hip Fracture

  MAUDE report 10640741 ↗
• InjuryOct 5, 2020Fracture; Fracture

  IT HAS BEEN REPORTED "BROKEN STEM IN SITU".

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 10626024 ↗
• InjurySep 18, 2019Fracture; Fracture

  REVISION OF GMRS DISTAL FEMORAL REPLACEMENT DUE TO STEM FRACTURE. PATIENT SUFFERED ANAPHYLACTIC RESPONSE TO CEMENT CONTAINING GENTAMICIN AFTER IMPLANTATION OF ORIGINAL DISTAL FEMORAL REPLACEMENT (NON-STRYKER CEMENT).

  Patient problems: Injury

  MAUDE report 9082960 ↗
• InjuryJul 19, 2018Break; Break

  AS REPORTED: "THE ORIGINAL 11 X 127 FEMORAL STEM BROKE. DURING THE REVISION WE EXPLANTED THE BROKEN STEM AND REPLACED IT".

  Patient problems: Injury

  MAUDE report 7704129 ↗