INHANCE 5500-11-290Recalls & reported problems
Depuy (Ireland) · INHANCE SHOULDER SYSTEM MODULAR UNITI PLATFORM BASEPLATE LARGE Ø29mm CEMENTLESS · Class 2 · Implant
All models of INHANCE (202)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10603295553205), received between Mar 11, 2025 and Mar 11, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Difficult to Insert” (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
- Difficult to Insert1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 11, 2025Difficult to Insert; Difficult to Insert
IT WAS REPORTED THAT THE SURGEON COULD NOT ADVANCE THE 35MM CENTRAL SCREW INTO THE LARGE PLATFORM BASEPLATE. THE SCREW WOULD NOT ADVANCE PAST THE FACE OF THE BASEPLATE AFTER SEVERAL ATTEMPTS AND RE-DRILLING. FINALLY, A 7X15MM CENTRAL POST WAS PLACED INSTEAD OF THE CENTRAL SCREW. THE CENTRAL POST WAS ABLE TO BE FULLY SEATED. ONLY ONE CENTRAL SCREW WAS SCARRED UP JUST BELOW THE HEAD, THE ORIGINAL 35MM. THE SCARRING WAS DUE TO THE SCREW SOMEHOW INTERFERING WITH THE INNER BOSS OF THE BASEPLATE. THE SCREW WAS CLEAN OUT OF THE BOX. THERE WAS APPROXIMATELY 10 MINUTES OF SURGICAL DELAY TO DETERMINE THE COURSE OF ACTION AND EXECUTE IT WHICH WAS TO SWITCH TO A CENTRAL POST IMPLANT. THERE WAS NO PATIENT HARM. AFFECTED SIDE: RIGHT SHOULDER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21578122 ↗
Other prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented devices
- Comprehensive Reverse Shoulder 115310Biomet Orthopedics, LLC · prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented1 death99 reports
- INHANCE 5120-00-110Depuy (Ireland) · prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented75 reports
- Comprehensive® Reverse Shoulder XL-115364Biomet Orthopedics, LLC · prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented1 recall7 reports
- Comprehensive® Reverse Shoulder XL-115366Biomet Orthopedics, LLC · prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented1 recall4 reports
- Comprehensive® Reverse Shoulder 180550Biomet Orthopedics, LLC · prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented2 deaths43 reports
- Comprehensive® Reverse Shoulder 180551Biomet Orthopedics, LLC · prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented42 reports
- DJO SURGICAL 521-07-246Encore Medical, L.P. · prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented42 reports
- Comprehensive® 110031399Zimmer, Inc. · prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented1 death36 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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