MRS 6485-3-313Recalls & reported problems
Howmedica Osteonics Corp. · Long Curved Cemented Stem · Class 2 · Implant
All models of MRS (25)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327048452), received between Sep 16, 2019 and Mar 28, 2023 — classified as 2 injuries.
The most frequently reported specific device problem is “Degraded” (1 report).
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
Device problems
- Degraded1
- Fracture1
- Osseointegration Problem1
Patient problems
- Fall1
- Inadequate Osseointegration1
- Injury1
- Insufficient Information1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryMar 28, 2023Degraded; Fracture; Degraded; Fracture
BROKEN 203X13MM CURVED GMRS STEM IN SITU IN PATIENT REVISION SURGERY REQUIRED SURGEON REPORTED THAT WHILE THE PATIENT WAS WALKING, THEY FELT THEIR LEG BUCKLE. FRACTURED COMPONENT CONFIRMED BY X-RAY.
Patient problems: Fall; Insufficient Information
MAUDE report 16625696 ↗InjurySep 16, 2019Osseointegration Problem; Osseointegration Problem
IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO A LOOSE FEMORAL STEM. THE ENTIRE CONSTRUCT EXCEPT FOR THE TIBIAL BASEPLATE AND TIBIAL STEM WERE REVISED. SPOKE TO REP. REP CONFIRMED THE ONLY ALLEGATION WAS FOR THE FEMORAL STEM. REP PROVIDED PRIMARY AND REVISION USAGE AND EXPLANT PICTURES, AND CONFIRMED THAT NO FURTHER INFORMATION.
Patient problems: Inadequate Osseointegration; Injury
MAUDE report 9070566 ↗
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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