Cobalt Bone Cement 402282Recalls & reported problems
Biomet Orthopedics, LLC · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00880304560789), received between Apr 20, 2021 and Apr 23, 2021 — classified as 4 injuries.
The most frequently reported specific device problem is “Loss of or Failure to Bond” (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
Device problems
- Loss of or Failure to Bond3
- Loosening of Implant Not Related to Bone-Ingrowth2
Patient problems
- Failure of Implant2
- Pain2
- Joint Laxity1
- Osteolysis1
- Scar Tissue1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryApr 23, 2021Loss of or Failure to Bond; Loss of or Failure to Bond
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Failure of Implant
MAUDE report 11716785 ↗InjuryApr 21, 2021Loss of or Failure to Bond; Loosening of Implant Not Related to Bone-Ingrowth; Loss of or Failure to Bond; Loosening of Implant Not Related to Bone-Ingrowth
UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.
Patient problems: Joint Laxity; Pain; Scar Tissue
MAUDE report 11701968 ↗InjuryApr 20, 2021Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Osteolysis; Pain
MAUDE report 11694656 ↗InjuryApr 20, 2021Loss of or Failure to Bond; Loss of or Failure to Bond
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Failure of Implant
MAUDE report 11694309 ↗
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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