INHANCE 6500-10-102Recalls & reported problems
Depuy (Ireland) · INHANCE SHOULDER SYSTEM REVERSE IMPACTOR PUCK · Class 1
All models of INHANCE (202)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10603295547273), received between Feb 8, 2023 and Jul 28, 2026 — classified as 6 malfunctions.
The most frequently reported specific device problem is “Break” (5 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.
Reports received per month
Most reported problems
Device problems
- Break5
- Crack1
- Material Deformation1
- Naturally Worn1
Patient problems
- No Clinical Signs, Symptoms or Conditions6
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 28, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50056777 ↗MalfunctionAug 1, 2025Material Deformation; Material Deformation
IT WAS REPORTED THAT THE GREY PLASTIC STEM/SHELL OF THE INSERTION WASHER WAS DAMAGED; IT WAS CUT UP AND HAD MANY HOLES IN IT FROM TRYING TO REMOVE IT WITH A SHARP INSTRUMENT, BUT IT WAS ALL IN ONE PIECE. THERE WAS NO DELAY IN THE CASE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22687019 ↗MalfunctionJun 3, 2024Break; Break
THE INSTRUMENT BROKE INTO 2 PIECES WHILE IMPACTING THE TRIAL. THERE WERE NO DELAYS OR PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19454038 ↗MalfunctionApr 19, 2024Break; Crack; Naturally Worn; Break; Crack; Naturally Worn
IT WAS REPORTED THAT THE INSTRUMENTS ARE BROKEN OR DAMAGED. PARTS WERE EITHER CRACKED OR COMPLETELY BROKEN DUE TO EXCESSIVE USE AND WEAR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19142753 ↗MalfunctionJun 22, 2023Break; Break
IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE THE IMPACTOR TIP BROKE DURING USE. A NEW IMPACTOR WAS QUICKLY OPENED AND USED. THE SURGERY WAS COMPLETED WITHOUT ANY FURTHER DELAYS OR ISSUES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17181861 ↗MalfunctionFeb 8, 2023Break; Break
IT WAS REPORTED THAT THE REVERSE IMPACTOR PUCK BROKE. BASEPLATE INSERTER ROD CROSS THREADED. LARGE HUMERAL SIZER DISC CRACKED. THERE WAS NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16323745 ↗
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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