DJO SURGICAL 600-15-100Recalls & reported problems
Encore Medical, L.P. · COBALT G-HV BONE CEMENT 40GM · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 14
- Deaths reported
- 0
- Injuries reported
- 11
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00190446138013), received between Jan 7, 2019 and Jun 13, 2025 — classified as 11 injuries, 3 malfunctions.
The most frequently reported specific device problem is “Contamination” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem9
- Appropriate Device Problem Term/Code Not Available1
- Contamination1
- Loose or Intermittent Connection1
- Material Integrity Problem1
- Problem with Sterilization1
- Tear, Rip or Hole in Device Packaging1
- Unsealed Device Packaging1
Patient problems
- Implant Pain6
- Joint Laxity5
- No Known Impact Or Consequence To Patient3
- Unspecified Infection3
- Insufficient Information2
- Pain1
- Swelling/ Edema1
Recent adverse event reports
The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.
InjuryJun 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO LOOSENING, INFECTION AND PAIN.
Patient problems: Pain; Swelling/ Edema; Unspecified Infection
MAUDE report 22207823 ↗InjuryJul 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO PAIN AND LOOSENING.
Patient problems: Implant Pain; Joint Laxity
MAUDE report 19672437 ↗InjuryJul 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO PAIN AND LOOSENING.
Patient problems: Implant Pain; Joint Laxity
MAUDE report 19672435 ↗InjuryJun 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO PAIN AND LOOSENING.
Patient problems: Implant Pain; Joint Laxity
MAUDE report 19494862 ↗InjuryMay 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO PAIN AND LOOSENING
Patient problems: Implant Pain; Joint Laxity
MAUDE report 19320359 ↗InjuryApr 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO INFECTION & LOOSENING.
Patient problems: Joint Laxity; Unspecified Infection
MAUDE report 19102517 ↗MalfunctionSep 12, 2023Material Integrity Problem; Material Integrity Problem
INSTRUMENT FAILURE - 30 MINUTE DELAY IN SURGERY.
Patient problems: Insufficient Information
MAUDE report 17733795 ↗InjuryJul 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJul 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryAug 8, 2022Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO AN INFECTION IN JOINT.
Patient problems: Unspecified Infection
MAUDE report 15184446 ↗InjuryApr 30, 2021Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - INITIAL LEFT TOTAL KNEE ARTHROPLASTY WAS PERFORMED. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO LOOSENING OF THE TIBIAL COMPONENT. DURING THE REVISION, A COMPLETE LACK OF ADHERENCE OF THE CEMENT TO THE TIBIAL IMPLANT WAS NOTED. THE TIBIAL COMPONENT AND BEARING WERE REVISED WITHOUT COMPLICATION.
Patient problems: Insufficient Information
MAUDE report 11758088 ↗InjuryApr 4, 2019Problem with Sterilization; Tear, Rip or Hole in Device Packaging
COMPLAINT - DUE TO THE OUTER PACKAGING TEARING AND CONTAMINATING THE STERILE PACKAGE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8482735 ↗MalfunctionMar 21, 2019Unsealed Device Packaging
COMPLAINT - WHILE OPENING THE COBALT CEMENT, STERILE PACK OPENED UNINTENTIONALLY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8441416 ↗MalfunctionJan 7, 2019Contamination
REPORTED INCIDENT - PACKAGING COMPLAINT: A HOSPITAL CONTAMINATED THE STERILE FIELD. THE OPERATING ROOM DIRECTOR IS DEMANDING ANSWERS ON WHY THE PACKAGING CHANGED AND WHEN IT WILL CHANGE BACK. THEY WERE VERY UPSET THE MORNING THAT THEY OPENED UP THE NEW PACKAGES. ONCE THEY WERE IN SERVICE ON THE NEW TECHNIQUE, THEY WERE OKAY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8222224 ↗
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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