GLOBAL ADVANTAGE 2128-02-050Recalls & reported problems
Depuy (Ireland) · GLOBAL ADVANTAGE + IMPACTION BLOCK · Class 1
All models of GLOBAL ADVANTAGE (28)
Data updated Oct 18, 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 10603295088196), received between Feb 21, 2018 and Oct 24, 2018 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (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.
Most reported problems
Device problems
- Break1
- Device-Device Incompatibility1
Patient problems
- No Consequences Or Impact To Patient1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 24, 2018Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE IMPACTION STAND IS WORN AND THE STEM DOESN¿T FIT TIGHTLY. THERE WAS A TWO MINUTES SURGICAL DELAY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7999402 ↗MalfunctionFeb 21, 2018Break; Break
DER STATES THAT THE SURGEON WAS ASSEMBLING THE CTA HEAD AND STEM ON BACK TABLE. WHILE MALLETING THE IMPLANTS TOGETHER THE BLUE PLASTIC FLAKES BROKE OFF ONTO THE BACK TABLE. THERE WAS SOME EVIDENT DAMAGE TO THE ASSEMBLING TOWER. THE SURGEON ALSO WASHED OFF THE IMPLANT TO POSSIBLY REMOVE ANY RESIDUAL PARTICLES. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7285207 ↗
Other IMPACTOR devices
- PINNACLE 2217-50-041Depuy (Ireland) · IMPACTOR4,295 reports
- ATTUNE 2544-01-006Depuy (Ireland) · IMPACTOR1 recall2,539 reports
- ATTUNE 2544-01-003Depuy (Ireland) · IMPACTOR1 recall1,498 reports
- ATTUNE 2544-01-017Depuy (Ireland) · IMPACTOR1 recall1,456 reports
- ATTUNE 2544-01-004Depuy (Ireland) · IMPACTOR1 recall875 reports
- DURALOC 2360-71-000Depuy Orthopaedics, Inc. · IMPACTOR716 reports
- SPECIALIST 2581-11-000Depuy (Ireland) · IMPACTOR704 reports
- INHANCE 6205-10-103Depuy (Ireland) · IMPACTOR337 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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