MRH 6481-3-111Recalls & reported problems
Howmedica Osteonics Corp. · MRH Knee Tibial Baseplate · Class 2 · Implant
All models of MRH (35)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 7
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 07613327045314), received between Apr 3, 2019 and Aug 6, 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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem3
- Insufficient Device Problem Information2
- Loss of Osseointegration2
Patient problems
- Unspecified Infection3
- Inadequate Osseointegration2
- Bone Fracture(s)1
- Fall1
- Injury1
- Insufficient Information1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
InjuryAug 6, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
INFORMATION RECEIVED FROM (B)(4) INDICATES THE FOLLOWING: FAILED R TKA, PAIN. FEMORAL AND TIBIAL COMPONENTS REMOVED.
Patient problems: Insufficient Information
MAUDE report 22724387 ↗InjuryAug 6, 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: PJI. ALL COMPONENTS REMOVED. LEFT KNEE.
Patient problems: Unspecified Infection
MAUDE report 22724330 ↗InjuryAug 6, 2025Loss of Osseointegration; Loss of Osseointegration
INFORMATION RECEIVED FROM (B)(4) INDICATES THE FOLLOWING: ASEPTIC LOOSENING OF TIBIA BUT DON'T SEE ANY REVISION SURGERY. LEFT KNEE.
Patient problems: Inadequate Osseointegration
MAUDE report 22724324 ↗InjuryAug 5, 2025Loss of Osseointegration; Loss of Osseointegration
INFORMATION RECEIVED FROM (B)(4) INDICATES THE FOLLOWING: ASEPTIC LOOSENING. ALL COMPONENTS REMOVED. LEFT KNEE.
Patient problems: Inadequate Osseointegration
MAUDE report 22720142 ↗InjuryJul 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
INFORMATION RECEIVED FROM (B)(4) INDICATES THE FOLLOWING: PROSTHETIC JOINT INFECTION. INFECTION DIAGNOSED AS COAG NEGATIVE STAPH, BUT UNCLEAR IF SPACER WAS PLACED (STUDY DATA INDICATES NO COMPONENTS WERE REMOVED). LEFT KNEE.
Patient problems: Unspecified Infection
MAUDE report 22673377 ↗InjuryJul 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
INFORMATION RECEIVED FROM (B)(4) INDICATES THE FOLLOWING: (B)(4). ALL COMPONENTS REMOVED. LEFT KNEE.
Patient problems: Unspecified Infection
MAUDE report 22665016 ↗InjuryApr 3, 2019Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO A TIBIAL PERIPROSTHETIC FRACTURE SUSTAINED IN A FALL. 8 OF THE 10 DEVICES IN A GMRS/MRS/MRH KNEE CONSTRUCT (NOT THE FEMORAL COMPONENT OR STEM) WERE REVISED TO MRH DEVICES.
Patient problems: Bone Fracture(s); Fall; Injury
MAUDE report 8479555 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page