MRS 6485-3-008Recalls & reported problems
Howmedica Osteonics Corp. · Straight Cemented Stem · Class 2 · Implant
All models of MRS (25)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327048285), received between Dec 12, 2022 and Dec 12, 2022 — classified as 1 injury.
The most frequently reported specific device problem is “Corroded” (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 16, 2026.
Most reported problems
Device problems
- Corroded1
- Fracture1
Patient problems
- Cancer1
- Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryDec 12, 2022Corroded; Fracture; Corroded; Fracture
IT WAS REPORTED BY THE SALE REP. THAT GMRS STEM BROKE IN PATIENT BODY. PATIENT IS A LONG-TERM OSTEOSARCOMA SURVIVOR. HE WAS WALKING AND SUDDENLY HEARD A SCRATCH SOUND, FOLLOWED BY SEVERE LEFT THIGH PAIN. HE WAS UNABLE TO BEAR WEIGHT THEREAFTER. PRIOR TO THIS, PATIENT WAS ABLE TO DO STRAIGHT LEG RAISES AND WALK PAIN FREE. BROKEN IMPLANT (6485-3-008) COULD NOT BE REMOVED FROM THE PATIENT. PLEASE EXPLAIN WHY THE BROKEN PART WAS CEMENTED IN THE CANAL. PATIENT HAS AN AMPUTATION LEG DUE TO A FRACTURED STEM? PLEASE CONFIRM. YES. AND ALSO DUE TO FINANCIAL CHALLENGE FOR THE REVISION OF OPERATION COST.
Patient problems: Cancer; Pain
MAUDE report 15962984 ↗
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 16, 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