Arthrex® AR-9100-09PRecalls & reported problems
Arthrex, Inc. · UNIVERS II HUMERAL STEM 9MM · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867057104), received between Oct 4, 2019 and May 1, 2024 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Fitting Problem” (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
- Fitting Problem1
- Positioning Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- Pain1
- Unspecified Infection1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 1, 2024Fitting Problem; Fitting Problem
ON (B)(6) 2021, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-9100-09P HUMERAL STEM, AN AR-9152-20P HUMERAL HEAD, AND AN AR-9100-07S UNIVERS APEX HUMERAL STEM ALL FAILED TO FIT. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2021. SURGEON COMPLETED CASE BY USING A LARGER STEM. ADDITIONAL INFORMATION RECEIVED 12/3/2021: THIS OCCURRED DURING A TOTAL SHOULDER ARTHROPLASTY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19219776 ↗InjuryOct 4, 2019Positioning Problem
IT WAS REPORTED BY THE PATIENT THAT HE HAD ARTHREX IMPLANTS IMPLANTED IN 2018. ACCORDING TO THE IMPLANT CARD, THE FOLLOWING DEVICES WERE IMPLANTED: AR-9100-09P & AR-9148-21P. THE PATIENT WAS CONTINUOUSLY EXPERIENCING VERY INTENSE (UNBEARABLE) PAIN. THE PATIENT WAS TREATED SEVERAL TIMES BY DIFFERENT DOCTORS DUE TO THE PAIN. THE RESULTS SHOWED THAT THE PROSTHESIS POSITION IS TOO HIGH AND HAS ONLY A SMALL JOINT GAP. DUE TO THE CONSTANT FRICTION, THE PATIENT NOW HAS A CHRONIC INFECTION. THE SECOND OPINION OF THE DOCTORS WAS THAT THE REMOVAL OF THE ENTIRE SHAFT (NOT CEMENTED) IS NECESSARY. HOWEVER, THIS LEADS TO THE FACT THAT THE ENTIRE HUMERUS MUST BE COMPLETELY DAMAGED.
Patient problems: Pain; Unspecified Infection
MAUDE report 9155772 ↗
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- Alliance® SBGL3007Zimmer, Inc. · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED162 reports
- DELTA XTEND 130760138Depuy (Ireland) · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED146 reports
- DELTA XTEND 130790030Depuy (Ireland) · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED132 reports
- 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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