VERSABOND 71271340Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 03596010494726), received between Aug 2, 2017 and May 12, 2020 — classified as 1 death, 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (3 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 16, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryMay 12, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, DURING AN UNSPECIFIED SURGERY, THE PATIENT HAD A TRANSIENT ALLERGIC REACTION FOR ABOUT 4 MIN AFTER VERSABOND WAS INJECTED. IT WAS NOTICED BY A DECREASE IN THE BLOOD PRESSURE. THE EVENT WAS RESOLVED AFTER MEDICATION. THE PATIENT WAS NOT HARMED BEYOND THE STATED EVENT.

  Patient problems: Low Blood Pressure/ Hypotension

  MAUDE report 10046580 ↗
• InjuryOct 3, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT TWO MINUTES AFTER THE USE OF BONE CEMENT, THE PATIENT DEVELOPED ARRHYTHMIAS, FREQUENT VENTRICULAR DIURNAL, AND DIURNAL RHYTHM.

  Patient problems: Arrhythmia

  MAUDE report 9151634 ↗
• MalfunctionDec 19, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING INTRA-OPERATIVE DISCARDING OF THE SELF-LOCKING PROSTHETIC STEM TO THE CEMENT PROSTHETIC INTERFACE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8181288 ↗
• InjuryMay 14, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT TWISTED HIS KNEE AND DEVELOPED BLEEDING. AN ASPIRATION WAS PERFORMED WITH ONLY ANTI-INFLAMMATORY MEDICATION.

  Patient problems: Injury

  MAUDE report 7513006 ↗
• DeathAug 2, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT DIED DURING TOTAL HIP ARTHROPLASTY FOLLOWING CEMENTATION OF IMPLANT. VERSABOND BONE CEMENT WAS USED TO FIX, BUT 4 MINUTES LATER PATIENT REACTED WITH BREATHING, HEARTBEAT, BLOOD OXYGEN SATURATION DECREASED RAPIDLY, AND FINALLY DIED.

  Patient problems: Death; Low Oxygen Saturation; Reaction; Respiratory Distress; Shock, Surgical

  MAUDE report 6759765 ↗