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IT WAS REPORTED THAT DURING IMPLANTATION THE RALLY HV AB BONE CEMENT 40 GRAMS WAS OUTDATED AND USED IN THE PATIENT.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
- SMARTSET 3122-040Depuy (Ireland) · BONE CEMENT824 reports
- NA 3322-020Depuy (Ireland) · BONE CEMENT306 reports
- NA 3312-040Depuy (Ireland) · BONE CEMENT4 deaths258 reports
- NA 3332-040Depuy (Ireland) · BONE CEMENT4 deaths197 reports
- NA 5450-31-500Depuy (Ireland) · BONE CEMENT2 deaths168 reports
- NA 5450-32-500Depuy (Ireland) · BONE CEMENT1 death150 reports
- PALACOS® MV pro 80Heraeus Medical GmbH · Bone Cement2 recalls1 report
- PALACOS® R pro 80Heraeus Medical GmbH · Bone Cement2 recalls1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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