Arthrex® AR-9145-48Recalls & reported problems
Arthrex, Inc. · UNI GLENOID-PERIPHERAL LOCK SCRW · Class 2 · Implant
Data updated Oct 16, 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 00888867057753), received between Jan 3, 2023 and Oct 20, 2023 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Biocompatibility” (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
- Biocompatibility1
- Break1
- Entrapment of Device1
- Patient Device Interaction Problem1
Patient problems
- Foreign Body In Patient1
- Unspecified Infection1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryOct 20, 2023Biocompatibility; Patient Device Interaction Problem; Biocompatibility; Patient Device Interaction Problem
IT WAS REPORTED THAT AFTER AN INITIAL SURGERY ON (B)(6) 2023 THE PATIENT DEVELOPED A SEVERE INFECTION WHICH AFFECTED THE PATIENT FOR 6 MONTHS. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2023 TO REMOVE THE INVOLVED IMPLANTS. NO FURTHER INFORMATION RECEIVED.
Patient problems: Unspecified Infection
MAUDE report 17976800 ↗MalfunctionJan 3, 2023Break; Entrapment of Device
ON 12/15/2022 IT WAS REPORTED BY A SALES REPRESENTATIVE BY EMAIL THAT A AR-9145-48 UNIVERSAL GLENOID LOCKING SCREW BROKE WHEN BEING DRIVEN INTO A GLENOID. THIS WAS DISCOVERED DURING AN ECLIPSE TSA W/ CONVERTIBLE UNIVERSAL GLENOID ON (B)(6) 2022. THE TIP WAS REMOVED, BUT THE REMAINDER OF THE SCREW WAS LEFT IN THE PATIENT.
Patient problems: Foreign Body In Patient
MAUDE report 16086905 ↗
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- DJO SURGICAL 508-32-104Encore Medical, L.P. · shoulder prosthesis, reverse configuration1 recall203 reports
- DJO SURGICAL 509-00-032Encore Medical, L.P. · shoulder prosthesis, reverse configuration233 reports
- DELTA XTEND 130760000Depuy (Ireland) · shoulder prosthesis, reverse configuration223 reports
- DJO SURGICAL 508-00-032Encore Medical, L.P. · shoulder prosthesis, reverse configuration122 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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