Arthrex® AR-9550-12Recalls & reported problems
Arthrex, Inc. · UNIVERS REVERS SPACER 42+12MM · 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 00888867062337), received between Nov 23, 2020 and Nov 23, 2020 — classified as 1 injury.
The most frequently reported specific device problem is “Break” (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
- Break1
Patient problems
- Pain1
- Unspecified Infection1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryNov 23, 2020Break
IT WAS REPORTED THAT DURING A (B)(6) 2020 REVISION REVERSE TOTAL SHOULDER ARTHROPLASTY PROCEDURE THE FOLLOWING ISSUES OCCURRED WITH TWO ARTHREX INSTRUMENTS: INSTRUMENT 1: THE MEDIUM T-15 DRIVER (AR-9545-T15-02 #8001928) HAS BEEN COMPROMISED. WHEN TRYING TO EXTRACT THE CENTRAL SCREW FROM A UNIVERSAL GLENOID, THE TIP OF THE DRIVER BECAME TWISTED AND A SMALL PIECE BROKE OFF INTO THE HEAD OF THE CENTRAL SCREW. THERE WAS A 5 MINUTE DELAY IN SURGERY AS THE SCREW HEAD COULD NO LONGER BE ACCESSED. THE SURGEON USED OSTEOTOMES AROUND THE PERIPHERY OF THE BASEPLATE TO EVENTUALLY EXTRACT THE BASEPLATE AND CENTRAL SCREW AS ONE PIECE. THE INSTRUMENT BROKE INTO TWO PIECES. BOTH PIECES WERE RECOVERED, BUT THE SMALLER PIECE WAS LODGED INTO THE CENTRAL SCREW IMPLANT WHICH WAS NOT AVAILABLE FOR RETURN. THERE WAS NO UNPLANNED INCISION. A SECOND SURGERY IS NOT NECESSARY. DEVICE WILL BE RETURNING FOR EVALUATION. THE EVENT DID NOT OCCUR DURING THE INITIAL USE OF THE DEVICE. INSTRUMENT 2: THE TRINITY BASEPLATE IMPACTOR (AR-9165CDG #(10)051917) HAS BEEN COMPROMISED. THE SURGEON ENGAGED THE ALREADY IMPLANTED BASEPLATE WITH THE IMPACTOR SO THAT IMPACTION MIGHT DISRUPT THE BONY BOND WITH THE BASEPLATE. AFTER
Patient problems: Pain; Unspecified Infection
MAUDE report 10884427 ↗
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- DJO SURGICAL 508-32-101Encore Medical, L.P. · shoulder prosthesis, reverse configuration433 reports
- DJO SURGICAL 508-32-103Encore Medical, L.P. · shoulder prosthesis, reverse configuration421 reports
- DJO SURGICAL 509-00-036Encore Medical, L.P. · shoulder prosthesis, reverse configuration1 recall259 reports
- 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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