Arthrex® AR-9100-10MRecalls & reported problems
Arthrex, Inc. · Univers Apex OptiFit Humeral Stem, 10mm · Class 2 · Implant
Data updated Oct 16, 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 00888867404311), received between Jun 17, 2024 and Aug 25, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Device Dislodged or Dislocated1
- Difficult or Delayed Positioning1
Patient problems
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 25, 2025Difficult or Delayed Positioning; Difficult or Delayed Positioning
ON 08/08/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9100-10M HUMERAL STEM INFERIOR SCREW WOULD NOT TURN. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT. THE ISSUE WAS IDENTIFIED INTRAOPERATIVELY WHILE THE PATIENT WAS ON THE TABLE. THIS CREATED AN IMMEDIATE NEED FOR RESOLUTION TO PROCEED WITH THE SURGERY WITHOUT DELAY. THE ATTENDING SURGEON MANIPULATED THE SCREW MECHANISM AND WAS ULTIMATELY ABLE TO GET IT TO FUNCTION, ALLOWING THE PROCEDURE TO CONTINUE. THE SCREW WAS NOTED TO BE DIFFICULT TO OPERATE INITIALLY, WHICH COULD INDICATE A POTENTIAL MANUFACTURING OR PRESETTING ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22885326 ↗MalfunctionJun 17, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
ADDITIONAL INFORMATION WAS PROVIDED ON 05/22/2024, WHERE THE SALES REPRESENTATIVE STATED THAT THE PATIENT'S BONE QUALITY WAS SOFTER THAN USUAL, WHICH IS WHY THEY SWITCHED TO A STEM AS OPPOSED TO AN ECLIPSE CAGE SCREW. THE FIT OF THE IMPLANT WAS VERY SOLID. APEX BROACH HANDLES WERE USED TO PREPARE THE BONE SOCKET.
Patient problems: Insufficient Information
MAUDE report 19547285 ↗
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- DJO SURGICAL 509-00-436Encore Medical, L.P. · Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented124 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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