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GMRS 6497-1-600Recalls & reported problems

Howmedica Osteonics Corp. · Distal Femoral Growing Prosthesis · Class 2 · Implant

All models of GMRS (32)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
2
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327142631), received between Oct 24, 2017 and Mar 29, 2018 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Mechanical Problem” (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 18, 2026.

Most reported problems

Device problems

  • Mechanical Problem2
  • Adverse Event Without Identified Device or Use Problem1
  • Mechanical Jam1

Patient problems

  • Ambulation or Postural Difficulties1
  • Injury1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • InjuryMar 29, 2018Mechanical Problem; Mechanical Problem

    IN FOLLOWING UP WITH THE SALES REP (INTRA-OPERATIVE EVENT), REP RESPONDED THAT THE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2017. REVISION WAS DUE TO MECHANICAL FAILURE OF THE DEVICE (LOCKING KNOB) REPORTED IN ANOTHER REPORT. THIS REPORT IS FOR THE REVISION ON (B)(6) 2017.

    Patient problems: Injury

    MAUDE report 7382886 ↗
  • MalfunctionOct 24, 2017Mechanical Problem; Mechanical Jam; Adverse Event Without Identified Device or Use Problem; Mechanical Problem; Mechanical Jam; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT SURGEON WAS PERFORMING A LIMB-LENGTHENING ON THE GMRS KNEE SYSTEM IN PATIENT'S RIGHT KNEE. REP REPORTED THERE WERE ISSUES WITH THE SMALLER 2MM LOCKING SCREWDRIVER TO UNLOCK THE PROSTHESIS. SURGEON ATTEMPTED TO TURN THE BIGGER KNOB TO LENGTHEN THE PATIENT'S LEG - THE KNOB TURNED 1 FULL TURN AND LOCKED. AS REPORTED BY REP: "THE LOCKING KNOB WASN'T BITING WITH THE DRIVER." THE SURGEON RETURNED THE PROSTHESIS TO THE BASELINE STATE AND ENDED THE PROCEDURE. REP REPORTED THAT THE PATIENT WILL SUFFER A LEG LENGTH DISCREPANCY UNTIL A SOLUTION CAN BE FOUND. THE SCREWDRIVERS ARE AVAILABLE FOR RETURN TO STRYKER, THE PROSTHESIS REMAINS IMPLANTED IN THE PATIENT.

    Patient problems: Ambulation or Postural Difficulties

    MAUDE report 6973888 ↗

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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