DONJOY 11-0021-3Recalls & reported problems
Djo, LLC · PLAYMAKER II, X-ROM, M, BLACK · Class 1
All models of DONJOY (11)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00190446752035), received between Aug 14, 2024 and Sep 14, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Mechanical Problem” (2 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.
Reports received per month
Most reported problems
Device problems
- Mechanical Problem2
- No Apparent Adverse Event2
- Unintended System Motion2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 14, 2024Mechanical Problem; Unintended System Motion; No Apparent Adverse Event; Mechanical Problem; Unintended System Motion; No Apparent Adverse Event
IT WAS REPORTED THAT THE RED BUTTON BROKE AND WILL NOT LOCK OUT .
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20219170 ↗MalfunctionAug 14, 2024Mechanical Problem; Unintended System Motion; No Apparent Adverse Event; Mechanical Problem; Unintended System Motion; No Apparent Adverse Event
IT WAS REPORTED THAT ROM RESTRICTION DOES NOT LOCK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19987482 ↗
Other JOINT, KNEE, EXTERNAL BRACE devices
- DeRoyal ER4433-19Deroyal Industries, Inc. · JOINT, KNEE, EXTERNAL BRACE2 reports
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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