MRH 6481-1-131Recalls & reported problems
Howmedica Osteonics Corp. · MRH Knee Femoral Component · Class 2 · Implant
All models of MRH (35)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07613327045376), received between Jan 15, 2020 and Jul 31, 2025 — classified as 6 injuries.
The most frequently reported specific device problem is “Fracture” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Fracture3
- Adverse Event Without Identified Device or Use Problem1
- Break1
- Detachment of Device or Device Component1
- Loss of Osseointegration1
Patient problems
- Ambulation or Postural Difficulties2
- Insufficient Information2
- Bone Fracture(s)1
- Inadequate Osseointegration1
- Injury1
- Pain1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
InjuryJul 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
INFORMATION RECEIVED FROM IIS 2023-001 INDICATES THE FOLLOWING: SPIRAL FX JUST ABOVE FEMORAL IMPLANT. ORIF R FEMUR FX.
Patient problems: Bone Fracture(s)
MAUDE report 22675421 ↗InjuryJul 9, 2025Loss of Osseointegration; Loss of Osseointegration
REVISION OF MRH FEMUR WITH PRESS-FIT STEM, FOUND LOOSE.
Patient problems: Inadequate Osseointegration
MAUDE report 22459235 ↗InjuryMar 6, 2024Fracture; Fracture
REVISION OF RIGHT MRH DUE TO IMPLANT BREAKAGE. PRIMARY PROCEDURE PERFORMED ON (B)(6) 2019. FEMORAL STEM SNAPPED FROM MRH FEMORAL COMPONENT IN SITU. DATE OF BREAKAGE UNKNOWN, REVISION WAS PERFORMED ON (B)(6) 2024. FEMORAL AND TIBIAL IMPLANTS REMOVED. REVISED TO DISTAL FEMORAL AND PROXIMAL TIBIAL GMRS.
Patient problems: Insufficient Information
MAUDE report 18844139 ↗InjuryAug 10, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
FEMORAL STEM DISASSOCIATED FROM THE FEMORAL COMPONENT.
Patient problems: Ambulation or Postural Difficulties
MAUDE report 15204275 ↗InjuryFeb 24, 2021Fracture; Fracture
PATIENT NOW PRESENTS WITH A FRACTURE OF THE FEMORAL STEM AT THE JUNCTION OF THE BODY AND REQUIRES EXCHANGE OF FEMORAL AND HINGE COMPONENTS ON (B)(6) 2020.
Patient problems: Ambulation or Postural Difficulties; Insufficient Information
MAUDE report 11374833 ↗InjuryJan 15, 2020Break; Fracture; Break; Fracture
SURGEON REVISED A MODULAR ROTATING HINGE KNEE TODAY AS THE FEMORAL COMPONENT¿S STEM BOSS HAD FRACTURED. HE REVISED IT TO A GMRS DISTAL FEMUR REPLACEMENT. 2HRS SURGICAL DELAY.
Patient problems: Injury; Pain
MAUDE report 9593586 ↗
Other PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER devices
- ELEOS™ 25001208EOnkos Surgical, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER3 deaths193 reports
- ELEOS™ THSMWRS01MOnkos Surgical, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER190 reports
- "UNITED" USTAR II Hip System 1115-1413United Orthopedic Corp. · Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer3 recalls3 reports
- "UNITED" USTAR II Hip System 1115-1217United Orthopedic Corp. · Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer3 recalls0 reports
- "UNITED" USTAR II Hip System 1115-1417United Orthopedic Corp. · Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer3 recalls0 reports
- "UNITED" USTAR II Hip System 1115-1213United Orthopedic Corp. · Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer3 recalls0 reports
- Endo-Model Modular Knee Prosthesis System 15-3816/11WALDEMAR LINK GmbH & Co. KG · Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer2 recalls6 reports
- Endo-Model Modular Knee Prosthesis System 15-3816/12WALDEMAR LINK GmbH & Co. KG · Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer2 recalls6 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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