Cobalt HV with Gentamicin 402283Recalls & reported problems
Biomet Orthopedics, LLC · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00880304560796), received between Apr 19, 2021 and Dec 7, 2021 — classified as 6 injuries.
The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (4 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 18, 2026.
Most reported problems
Device problems
- Loosening of Implant Not Related to Bone-Ingrowth4
- Unstable3
- Adverse Event Without Identified Device or Use Problem1
- Fracture1
- Loss of or Failure to Bond1
- Migration or Expulsion of Device1
Patient problems
- Pain6
- Failure of Implant1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
InjuryDec 7, 2021Fracture; Loosening of Implant Not Related to Bone-Ingrowth; Fracture; Loosening of Implant Not Related to Bone-Ingrowth
NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.
Patient problems: Failure of Implant; Pain
MAUDE report 12956007 ↗InjuryApr 22, 2021Unstable; Loosening of Implant Not Related to Bone-Ingrowth; Unstable; Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED PATIENT UNDERWENT A RIGHT KNEE REVISION PROCEDURE APPROXIMATELY 3 YEARS POST IMPLANTATION DUE TO PAIN, DISCOMFORT, INSTABILITY, AND DIFFICULTY AMBULATING CAUSED BY ASEPTIC LOOSENING OF THE TIBIA COMPONENT. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
Patient problems: Pain
MAUDE report 11711900 ↗InjuryApr 22, 2021Unstable; Loosening of Implant Not Related to Bone-Ingrowth; Unstable; Loosening of Implant Not Related to Bone-Ingrowth
THE INITIAL WAS SUBMITTED UNDER A WRONG MANUFACTURING SITE. THIS REPORT SHOULD BE VOIDED, AS IT WAS SUBMITTED IN ERROR. THIS PRODUCT WAS ACQUIRED BY ANOTHER COMPANY. FURTHER REPORTS WILL BE SUBMITTED UNDER THE CORRECTED MANUFACTURING SITE.
Patient problems: Pain
MAUDE report 11711898 ↗InjuryApr 22, 2021Unstable; Loosening of Implant Not Related to Bone-Ingrowth; Unstable; Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED PATIENT UNDERWENT A RIGHT KNEE REVISION PROCEDURE APPROXIMATELY 3 YEARS POST IMPLANTATION DUE TO PAIN, DISCOMFORT, INSTABILITY, AND DIFFICULTY AMBULATING CAUSED BY ASEPTIC LOOSENING OF THE TIBIA COMPONENT. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
Patient problems: Pain
MAUDE report 11711888 ↗InjuryApr 20, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Pain
MAUDE report 11694652 ↗InjuryApr 19, 2021Loss of or Failure to Bond; Migration or Expulsion of Device; Loss of or Failure to Bond; Migration or Expulsion of Device
IT WAS REPORTED THAT THE PATIENT UNDERWENT RIGHT TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY THE PATIENT UNDERWENT A REVISION PROCEDURE APPROXIMATELY TWO (2) YEARS POST IMPLANTATION DUE TO LOOSENING OF THE BONE CEMENT. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
Patient problems: Pain
MAUDE report 11684620 ↗
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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