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RALLY 71271570Recalls & reported problems

Smith & Nephew, Inc. · RALLY HV AB BONE CEMENT 40 GRAMS · Class 2 · Implant

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
3
Deaths reported
0
Injuries reported
3
Recalls naming it
0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00885556582220), received between Oct 2, 2018 and Aug 9, 2021 — classified as 3 injuries.

The most frequently reported specific device problem is “Use of Device Problem” (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

  • Adverse Event Without Identified Device or Use Problem2
  • Use of Device Problem1

Patient problems

  • Fibrosis1
  • Loss of Range of Motion1
  • No Clinical Signs, Symptoms or Conditions1
  • Pain1

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

  • InjuryAug 9, 2021Use of Device Problem; Use of Device Problem

    IT WAS REPORTED THAT DURING IMPLANTATION THE RALLY HV AB BONE CEMENT 40 GRAMS WAS OUTDATED AND USED IN THE PATIENT. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS PROBLEM.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12294343 ↗
  • InjuryOct 2, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT A MANIPULATION UNDER ANESTHESIA WAS PERFORMED TO THE PATIENT AS SHE DEVELOPED ARTHROFIBROSIS.

    Patient problems: Fibrosis

    MAUDE report 7928815 ↗
  • InjuryOct 2, 2018Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT THE PATIENT WAS FOUND TO HAVE POOR RANGE OF MOTION AND EXPERIENCING MORE PAIN THAN EXPECTED. AN ASPIRATION WAS PERFORMED TO RULE OUT INFECTION.

    Patient problems: Loss of Range of Motion; Pain

    MAUDE report 7927866 ↗

Other BONE CEMENT devices

All BONE CEMENT devices →

Sources and updates

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