INHANCE 6200-10-001Recalls & reported problems
Depuy (Ireland) · INHANCE SHOULDER SYSTEM VERSION INDICATOR · Class 1
All models of INHANCE (202)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This DePuy Inhance shoulder version indicator has 145 FDA adverse event reports, with no deaths and no injuries. Most describe parts breaking or snapping, including plastic pieces and clips, and some mention cracks or damaged threads. Most reports list no clinical signs. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 152
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 152 adverse event reports that list this exact device (DI 10603295538967), received between Dec 14, 2022 and Sep 30, 2026 — classified as 152 malfunctions.
The most frequently reported specific device problem is “Break” (134 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
- Break134
- Crack23
- Device-Device Incompatibility7
- Material Deformation2
- No Apparent Adverse Event1
- Unintended Movement1
Patient problems
- No Clinical Signs, Symptoms or Conditions140
- Insufficient Information15
Recent adverse event reports
The 25 most recent of 152 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Break; Device-Device Incompatibility
It was reported that the version indicator was damaged during decontamination process. Plastic clip was broken and will no longer affix to stem inserter.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50946027 ↗MalfunctionSep 30, 2026Break
It was reported that during Shoulder Repair surgery, the version indicator broke into 2 pieces when impacting humeral stem. All pieces retrieved. Please send a replacement to office.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50945500 ↗MalfunctionSep 29, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50928688 ↗MalfunctionSep 24, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50882454 ↗MalfunctionSep 21, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50845496 ↗MalfunctionSep 18, 2026Break
It was reported that during impaction of the humeral stem, the inclination guide broke. This did not impact the length of the surgery.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50823104 ↗MalfunctionSep 15, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50779951 ↗MalfunctionSep 10, 2026Break
It was reported that the version rod was found to be broken after decontamination. All available information has been disclosed.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50713894 ↗MalfunctionSep 10, 2026Break
It was reported that the VERSION INDICATOR instrument was broken by sterile processing department staff while being removed from the stem inserter for cleaning. The incident did not occur during surgery or in the operating room. All available information has been disclosed.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50713262 ↗MalfunctionAug 7, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50173099 ↗MalfunctionAug 5, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50141200 ↗MalfunctionJul 6, 2026Break
IT WAS REPORTED THAT THE VERSION GUIDE SNAPPED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25723562 ↗MalfunctionJun 1, 2026Break
IT WAS REPORTED THAT THE VERSION GUIDE CLIP WAS BROKEN. THE EVENT DID NOT OCCUR DURING SURGERY. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25354881 ↗MalfunctionMay 25, 2026Break; Material Deformation
IT WAS REPORTED THAT THREADS WERE DAMAGED/CROSS THREADED, AND THE PLASTIC PIECE BROKE OFF. THIS EVENT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25270793 ↗MalfunctionMay 22, 2026Break
IT WAS REPORTED THAT VERSION INDICATOR BROKE. THE PLASTIC SNAPPED UPON USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25257334 ↗MalfunctionMay 22, 2026Crack
IT WAS REPORTED THAT DURING INSPECTION OF A SECOND SET THE VERSION INDICATOR WAS CRACKED AND CLOSE TO BREAKING. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25254807 ↗MalfunctionMay 14, 2026Break
IT WAS REPORTED THAT THE PLASTIC CLAMP ON THE VERSION INDICATOR WAS BROKEN. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25175166 ↗MalfunctionMay 12, 2026Crack
IT WAS REPORTED THAT THE PLASTIC ATTACHMENT PIECE WAS CRACKED AND NEEDS REPLACING. THE EVENT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25154801 ↗MalfunctionMay 12, 2026Crack
IT WAS REPORTED THAT THE PLASTIC ATTACHMENT PIECE WAS CRACKED AND NEEDS REPLACING. THE EVENT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25154665 ↗MalfunctionMay 12, 2026Break
IT WAS REPORTED THAT VERSION INDICATOR WAS STRUCK WITH THE MALLET DURING IMPLANTING HUMERAL STEM CAUSING IT TO BREAK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25150566 ↗MalfunctionApr 30, 2026Break
IT WAS REPORTED THAT WHILE IMPLANTING THE HUMERAL STEM, THE VERSION ROD BROKE AND FELL OFF THE STEM INSERTER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25041918 ↗MalfunctionApr 29, 2026Break
IT WAS REPORTED THAT THE VERSION INDICATOR BROKE. IT WAS TOSSED IN GARBAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25034166 ↗MalfunctionApr 20, 2026Break
IT WAS REPORTED THAT THE VERSION GUIDE DEVICE WAS BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24927388 ↗MalfunctionApr 11, 2026Break
IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE IT WAS OBSERVED THAT THE VERSION GUIDE BROKE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24849330 ↗MalfunctionApr 8, 2026Crack
IT WAS REPORTED THAT DURING A TOTAL SHOULDER REPLACEMENT PROCEDURE, THE INSTRUMENTS WERE DISCOVERED TO BE CRACKED AFTER THE CASE WAS OVER WHEN THE INSTRUMENTS WERE CLEANED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24823014 ↗
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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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