RALLY 71271560Recalls & reported problems
Smith & Nephew, Inc. · RALLY HV BONE CEMENT 40 GRAMS · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00885556582213), received between Nov 2, 2018 and Nov 2, 2018 — classified as 1 injury.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (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
- Insufficient Device Problem Information1
Patient problems
- Injury1
- Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryNov 2, 2018Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT PATIENT HAS A SEVERE PAIN IN KNEE. BONE SCAN SHOWED THAT THE CEMENT FAILED AFTER JUST 5 MONTHS. TO CORRECT THE ISSUE, A NEW KNEE SURGERY HAS BEEN SCHEDULED FOR (B)(6) 2018 TO REPLACE THE ENTIRE KNEE WITH A NEW PRODUCT THAT IS MUCH MORE INVASIVE.
Patient problems: Injury; Pain
MAUDE report 8034067 ↗
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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