INHANCE 6200-30-040Recalls & reported problems
Depuy (Ireland) · INHANCE SHOULDER SYSTEM HUMERAL SIZER LARGE diameter 40mm · Class 1
All models of INHANCE (202)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 20
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 10603295539124), received between Jun 14, 2022 and Feb 13, 2026 — classified as 20 malfunctions.
The most frequently reported specific device problem is “Crack” (11 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
- Crack11
- Break6
- Device-Device Incompatibility3
- Scratched Material2
- Naturally Worn1
Patient problems
- No Clinical Signs, Symptoms or Conditions15
- Insufficient Information5
Recent adverse event reports
The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 13, 2026Crack
IT WAS REPORTED THAT DURING SETUP FOR TOTAL SHOULDER REVERSE ARTHROPLASTY SURGERY, THE GLENOID TIP INSERTER WOULD NOT THREAD ONTO THE INSERTION HANDLE, SO AN ADDITIONAL TRAY WAS OPENED. DURING TRAY REASSEMBLY, THE LARGE HUMERAL SIZER WAS FOUND CRACKED. THERE WAS NO PATIENT HARM OR TIME DELAY. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24334269 ↗MalfunctionFeb 10, 2026Break
IT WAS REPORTED THAT DURING A SHOULDER REPAIR SURGICAL PROCEDURE IT WAS OBSERVED THAT THE LARGE HUMERAL SIZER FELL ON FLOOR AND WAS BROKEN. IT WAS REPORTED THAT THERE WAS NO DELAY TO THE PROCEDURE AND THE PATIENT WAS NOT AFFECTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24308317 ↗MalfunctionFeb 10, 2026Device-Device Incompatibility
IT WAS REPORTED THAT DURING A TOTAL KNEE ARTHROSCOPY (TKA) SURGICAL PROCEDURE IT WAS OBSERVED THAT THE LARGE HUMERAL SIZER WAS DEFECTIVE AND WOULD NOT STAY ON THE SIZER HANDLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24308245 ↗MalfunctionAug 22, 2025Crack; Crack
IT WAS REPORTED THAT THE LARGE HUMERAL SIZER DISK AND LARGE GLENOID SIZER DISK WERE CRACKED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22873319 ↗MalfunctionAug 7, 2025Crack; Device-Device Incompatibility; Crack; Device-Device Incompatibility
IT WAS REPORTED THAT THE 20 DRIVER IS STRIPPED. M AND L SIZERS ARE CRACKED AND WON'T ACCEPT SIZER HANDLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22736761 ↗MalfunctionAug 7, 2025Crack; Device-Device Incompatibility; Crack; Device-Device Incompatibility
IT WAS REPORTED THAT THE 20 DRIVER IS STRIPPED. M AND L SIZERS ARE CRACKED AND WON'T ACCEPT SIZER HANDLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22736620 ↗MalfunctionJun 19, 2025Crack; Crack
IT WAS REPORTED THAT WHILE PUTTING SETS TOGETHER THE LEAD STERILE PROCESSING TECH SAID THAT THERE WERE 2 LARGE HUMERAL SIZES THAT LOOKED LIKE THEY WERE BEGINNING TO CRACK AND THE PERSON REMOVED THEM FROM THE SETS SAYING THEY CANNOT STERILIZE THEM UNTIL THEY ARE REPLACED. THIS HAPPENED POST OP SO NO NEGATIVE IMPACT TO PATIENT, OR SURGERY DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22292216 ↗MalfunctionJun 19, 2025Crack; Crack
IT WAS REPORTED THAT WHILE PUTTING SETS TOGETHER THE LEAD STERILE PROCESSING TECH SAID THAT THERE WERE 2 LARGE HUMERAL SIZES THAT LOOKED LIKE THEY WERE BEGINNING TO CRACK AND THE PERSON REMOVED THEM FROM THE SETS SAYING THEY CANNOT STERILIZE THEM UNTIL THEY ARE REPLACED. THIS HAPPENED POST OP SO NO NEGATIVE IMPACT TO PATIENT, OR SURGERY DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22292143 ↗MalfunctionApr 3, 2025Crack; Crack
IT WAS REPORTED THAT WHILE PUTTING TOGETHER THE SETS, IT WAS NOTICED THAT THERE WAS A SMALL CRACK GOING THRU THE LARGE SIZER. IT WAS STILL IN 1 PIECE BUT IT HAS BEEN REMOVED FROM THE SET UNTIL IT IS REPLACED. THERE WAS NO DELAY OR NEGATIVE IMPACT TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21761847 ↗MalfunctionApr 30, 2024Crack; Crack
ADDITIONAL INFORMATION WAS RECEIVED: ON ALL OF THE GLENOSPHERE INSERTER RODS AND GLENOSPHERE INSERTER ATTACHMENTS, THE THREADS WERE WARPED. THEY ARE NO LONGER WORKING PROPERLY BECAUSE THEY WILL NOT SCREW TOGETHER. I BELIEVE THE THREADS ARE EXTREMELY THIN AND WARP AFTER A SINGLE USE OFTEN.
Patient problems: Insufficient Information
MAUDE report 19211945 ↗MalfunctionApr 24, 2024Crack; Crack
IT WAS REPORTED THAT THE PRODUCT WAS CRACKED. UNKNOWN SURGICAL DELAY.
Patient problems: Insufficient Information
MAUDE report 19171952 ↗MalfunctionJan 29, 2024Break; Break
IT WAS REPORTED THAT THE SIZER BROKE DURING SHOULDER REPAIR .
Patient problems: Insufficient Information
MAUDE report 18596728 ↗MalfunctionJan 29, 2024Break; Break
IT WAS REPORTED THAT THE SIZER BROKE DURING SHOULDER REPAIR.
Patient problems: Insufficient Information
MAUDE report 18596712 ↗MalfunctionJan 29, 2024Break; Break
IT WAS REPORTED THAT THE INSTRUMENTS WERE BROKE DURING SHOULDER REPAIR.
Patient problems: Insufficient Information
MAUDE report 18595220 ↗MalfunctionDec 8, 2023Crack; Crack
IT WAS REPORTED THAT THE INSTRUMENT WAS CRACKED AFTER SURGERY. UNKNOWN SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18290138 ↗MalfunctionDec 7, 2023Scratched Material; Scratched Material
HUMERAL SIZERS ARE SCUFFED, STAFF WILL NOT REPROCESS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18281899 ↗MalfunctionJun 15, 2023Break; Break
IT WAS REPORTED THAT THE PLASTIC SIZER BROKE WHILE PUTTING THE HANDLE ON. NO PIECES WERE LEFT INSIDE THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17136389 ↗MalfunctionFeb 8, 2023Crack; Crack
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 16323782 ↗MalfunctionDec 5, 2022Break; Naturally Worn; Break; Naturally Worn
IT WAS REPORTED THAT WHILE PUTTING TOGETHER THE INHANCE INSTRUMENT TRAYS. SALES REP NOTICED THAT ONE OF THE SPIKES ON THE LARGE HUMERAL SIZER SEEMED TO EITHER BE WORN DOWN, OR BROKE OFF DURING WASHING. HE REMOVED IT FROM THE SET, AND FILLED OUT THE MDR FORM. THERE WAS NO NEGATIVE IMPACT TO THE PATIENT NOR WAS SURGERY TIME EXTENDED DUE TO THIS SINCE IT HAPPENED POST OP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15915769 ↗MalfunctionJun 14, 2022Scratched Material; Scratched Material
IT WAS REPORTED THAT THE HUMERAL SIZER BECAME SCUFFED,
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14685850 ↗
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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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