Arthrex® AR-9154-21PRecalls & reported problems
Arthrex, Inc. · USP II HUMERAL HEAD 54/21 · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888867057906), received between Dec 7, 2021 and Dec 7, 2021 — classified as 1 injury.
The most frequently reported specific device problem is “Loose or Intermittent Connection” (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.
Most reported problems
Device problems
- Appropriate Device Problem Term/Code Not Available1
- Loose or Intermittent Connection1
Patient problems
- Discomfort1
- Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryDec 7, 2021Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available
ON (B)(6) 2021, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-9100-08S HUMERAL STEM AND AR-9154-21P HUMERAL HEAD WERE ORIGINALLY IMPLANTED ON (B)(6) 2019. THE GLENOID ASPECT OF THE SURGERY SEEMED FINE BOTH DURING PRE-OP ASSESSMENT AS WELL AS INTRA-OP. ABOUT A YEAR AND A HALF AFTER IMPLANTATION, PATIENT BEGAN TO EXPERIENCE PAIN AND DISCOMFORT, IT LOOKED AS IF THE STEM HAD SUBSIDED AND IT WAS LOOSE. DURING THE REVISION SURGERY ON (B)(6) 2021, SAMPLES WERE TAKEN FROM BOTH THE JOINT SPACE AND CANAL AREA. ALL TESTS CAME BACK NEGATIVE FOR INFECTION, WHICH LEADS TO THE ISSUE BEING ASEPTIC LOOSENING. ONCE THE STEM WAS REMOVED THERE WAS NO BONY ON OR INGROWTH IN THE IMPLANT. SURGEON WAS ABLE TO REPLACE BOTH HUMERAL STEM AND HUMERAL HEAD WITH AN AR-9501-10P REVERS HUMERAL STEM, AN AR-9501-FX10N REVERS FRACTURE ADAPTER, AND AN AR-9150-19P UNIVERS HUMERAL HEAD.
Patient problems: Discomfort; Pain
MAUDE report 12954153 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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