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MRS 6485-3-010Recalls & reported problems

Howmedica Osteonics Corp. · Straight Cemented Stem-Replacement · Class 2 · Implant

All models of MRS (25)

Data updated Oct 18, 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 07613327048308), received between Aug 2, 2018 and Aug 2, 2018 — classified as 1 injury.

The most frequently reported specific device problem is “Break” (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

  • Break1
  • Fracture1

Patient problems

  • Injury1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryAug 2, 2018Break; Fracture; Break; Fracture

    IT WAS REPORTED BY THE ATTORNEY, THROUGH THE FILING OF A LEGAL CLAIM, THAT THE PATIENT HAD A STRYKER GMRS RIGHT DISTAL FEMUR SYSTEM IMPLANTED ON (B)(6) 2015. IT IS FURTHER ALLEGED THAT ON (B)(6) 2018, WHILE THE PATIENT WAS "CLIMBING INTO BED, HER STRYKER FEMUR ROD BROKE". AS A RESULT OF THE FRACTURE, THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2018.

    Patient problems: Injury

    MAUDE report 7743262 ↗

Other PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER devices

All PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER devices →

Sources and updates

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