MRH 6481-2-103Recalls & reported problems
Howmedica Osteonics Corp. · MRH Tibial Bearing Component · Class 2 · Implant
All models of MRH (35)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07613327045222), received between Aug 5, 2025 and Aug 6, 2025 — classified as 5 injuries.
The most frequently reported specific device problem is “Loss of Osseointegration” (4 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.
Reports received per month
Most reported problems
Device problems
- Loss of Osseointegration4
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Inadequate Osseointegration4
- Bone Fracture(s)1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
InjuryAug 6, 2025Loss of Osseointegration; Loss of Osseointegration
INFORMATION RECEIVED FROM (B)(4) INDICATES THE FOLLOWING: ASEPTIC LOOSENING. ALL COMPONENTS REMOVED. RIGHT KNEE.
Patient problems: Inadequate Osseointegration
MAUDE report 22724336 ↗InjuryAug 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
INFORMATION RECEIVED FROM (B)(4) INDICATES THE FOLLOWING: PERIPROSTHETIC TIBIAL FRACTURE. TIBIAL COMPONENTS REVISED. RIGHT KNEE.
Patient problems: Bone Fracture(s)
MAUDE report 22720001 ↗InjuryAug 5, 2025Loss of Osseointegration; Loss of Osseointegration
INFORMATION RECEIVED FROM IIS 2023-001 INDICATES THE FOLLOWING: ASEPTIC LOOSENING. ALL COMPONENTS REMOVED. LEFT KNEE.
Patient problems: Inadequate Osseointegration
MAUDE report 22716190 ↗InjuryAug 5, 2025Loss of Osseointegration; Loss of Osseointegration
INFORMATION RECEIVED FROM IIS 2023-001 INDICATES THE FOLLOWING: ASEPTIC LOOSENING. ALL COMPONENTS REMOVED. LEFT KNEE.
Patient problems: Inadequate Osseointegration
MAUDE report 22713682 ↗InjuryAug 5, 2025Loss of Osseointegration; Loss of Osseointegration
INFORMATION RECEIVED FROM (B)(4) INDICATES THE FOLLOWING: ASEPTIC LOOSENING. ALL COMPONENTS REMOVED. RIGHT KNEE.
Patient problems: Inadequate Osseointegration
MAUDE report 22713681 ↗
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 1115-1213United 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 1115-1217United Orthopedic Corp. · Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer3 recalls0 reports
- Endo-Model Modular Knee Prosthesis System 15-3816/12WALDEMAR LINK GmbH & Co. KG · Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer2 recalls6 reports
- Endo-Model Modular Knee Prosthesis System 15-3816/11WALDEMAR 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 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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