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HYDROSET 79-43905Recalls & reported problems

Stryker Leibinger GmbH & Co. KG · 5CC HYDROSET INJECTABLE CEMENT · Class 2 · Implant

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 07613154275007), received between May 12, 2021 and May 26, 2021 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Loss of Osseointegration” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem1
  • Loss of Osseointegration1

Patient problems

  • Device Embedded In Tissue or Plaque1
  • Pain1

Recent adverse event reports

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

  • InjuryMay 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY AFTER REPORTING PAIN AROUND THE AREA WHERE THE HYDROSET WAS USED.

    Patient problems: Pain

    MAUDE report 11886436 ↗
  • MalfunctionMay 12, 2021Loss of Osseointegration; Loss of Osseointegration

    IT WAS REPORTED BY THE HCP THAT THE HYDROSET HAD DISINTEGRATED IN THE PATIENT AND THE PATIENT UNDERWENT A REVISION SURGERY. THERE IS NO FURTHER INFORMATION KNOWN AT THIS TIME.

    Patient problems: Device Embedded In Tissue or Plaque

    MAUDE report 11811758 ↗

Other METHYL METHACRYLATE FOR CRANIOPLASTY devices

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.