MRH 6481-3-316Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 07613327043853), received between Sep 25, 2018 and Dec 18, 2025 — classified as 7 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryDec 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING INFORMATION WAS PROVIDED: THE PATIENT HAD AN INDEX RIGHT TKA OUTSIDE OF CORS SCOPE. ON (B)(6) 2020 PATIENT UNDERWENT REVISION FOR PJI, WITH ALL COMPONENTS EXCHANGED, INTO A ROTATING HINGE. THE PATIENT DEVELOPED PJI AGAIN AND WAS REVISED ON (B)(6) 2024, WITH AN OFF-LABEL USE OF COMPONENTS. ALL FEMORAL AND ROTATING HINGE COMPONENTS WERE EXCHANGED, EXCEPT TIBIAL COMPONENTS.

  Patient problems: Unspecified Infection

  MAUDE report 23836342 ↗
• InjuryOct 16, 2023Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THIS PI IS FOR THE POLY EXCHANGE ON (B)(6) 2023. AFTER REP REPORTED (REVISION OF A RIGHT DISTAL FEMORAL REPLACEMENT (B)(6) 2023 DUE TO A BROKEN IMPLANT), SPOKE TO REP. PATIENT HAD A PRIOR REVISION ON (B)(6) 2023 DUE TO FLEXION ISSUES. A 16MM INSERT WAS REVISED TO A 13MM INSERT. UPDATE: REVISION WAS PERFORMED ON (B)(6), 2019.

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 17937878 ↗
• InjuryJun 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED. AS REPORTED: "THIS PT. HAS BEEN REVISED AND ¿WASHED OUT¿ MULTIPLE TIMES DUE TO WOUND-HEALING ISSUES. HE RECEIVED A ¿WASHOUT¿ AND COMPONENT-SWAP, ALONG WITH THE PLACEMENT OF ANTIBIOTIC BEADS MADE FROM SIMPLEX CEMENT AND ANTIBIOTICS. REQUIRES ANOTHER REVISION. NO COMPLAINTS FILED AGAINST THE COMPONENTS THEMSELVES." SPOKE TO REP. SURGEON SUSPECTS INFECTION AS THE PATIENT'S WOUND IS NOT HEALING (REPORTED CAUSE IS THAT THE PATIENT CONTINUES TO SMOKE AGAINST MEDICAL ADVICE).

  Patient problems: Unspecified Infection

  MAUDE report 17103256 ↗
• InjuryApr 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED. AS REPORTED: "PT. PRESENTED WITH A DRAINING SURGICAL WOUND, FOLLOWING A KNEE-REVISION (OF COMPETITOR IMPLANTS) ON (B)(6) 2023. DR. OPTED TO PERFORM AN I&D AND SWAP OUT THE ¿PLASTIC¿ COMPONENTS. NO COMPLAINTS FILED AGAINST THE IMPLANTS THEMSELVES." NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Fluid Discharge

  MAUDE report 16680625 ↗
• InjurySep 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "PT. PRESENTED WITH DISCOMFORT OF THE RIGHT KNEE. DR. DETERMINED HIS KNEE WAS INFECTED. DR. PERFORMED AN EXTENSIVE I&D AND SWAPPED OUT ALL PREVIOUS COMPONENTS LISTED ON THE 10/1 SHEET FOR THE COMPONENTS LISTED ON THE 9/2 SHEET. NO COMPLAINTS FILED AGAINST THE IMPLANTS THEMSELVES, NO FURTHER INFO AVAILABLE."

  Patient problems: Unspecified Infection

  MAUDE report 15475919 ↗
• InjuryOct 16, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  AS REPORTED: "PROCEDURE: THE PATIENT UNDERWENT RIGHT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2016. PATIENT FELL AND SUSTAINED FEMUR FRACTURE. PATIENT UNDERWENT REMOVAL OF HARDWARE WITH RIGHT KNEE REVISION. PATELLA WAS RETAINED, ALL OTHER COMPONENTS WERE EXCHANGED ON (B)(6) 2016. RIGHT KNEE THEN GOT INFECTED AFTER KNEE REVISION REGARDING FRACTURE REVISION. PATIENT UNDERWENT REVISION FOR PJI ON (B)(6) 2018. ALL COMPONENTS (FIXED AND ROTATING) EXCEPT FEMUR WERE EXCHANGED".

  Patient problems: Injury; Unspecified Infection

  MAUDE report 7969799 ↗
• InjurySep 25, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT'S ALLEGED THROUGH THE FILING OF A LEGAL CLAIM THAT THE PATIENT UNDERWENT RECONSTRUCTION OF HIS LEFT DISTAL FEMUR. TWO SURGICAL INTERVENTIONS IN THE GMRS WERE PERFORMED IN SEPTEMBER AND NOVEMBER 2015 AS A TWO-STAGE TREATMENT FOR INFECTION. THIS EVENT RELATES TO THE MRH COMPONENTS WHICH WERE EXPLANTED ON (B)(6) 2015.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 7908195 ↗