Arthrex® AR-9550-06Recalls & reported problems
Arthrex, Inc. · UNIVERS REVERS SPACER 42+6MM · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888867062313), received between Mar 14, 2025 and Mar 14, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Defective Device” (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
- Defective Device1
- Positioning Failure1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 14, 2025Positioning Failure; Defective Device; Positioning Failure; Defective Device
ON (B)(6)2025, A SALES REPRESENTATIVE REPORTED VIA PHONE THAT A PATIENT UNDERWENT REVISION SURGERY. THE PATIENT HAD IMPLANTS FROM ANOTHER MANUFACTURER AND THOSE IMPLANTS WERE ATTEMPTED TO BE PAIRED WITH AN AR-9502F-42CPC ARTHREX UNIVERS REVERS SUTURE CUP AND A 9 MM STEM. THE STEM AND CUP WERE WELL FIXED WHILE THE BASEPLATE AND GLENOID COMPONENTS FROM ANOTHER MANUFACTURER HAD BEEN LEVERED OUT. BECAUSE THE STEM WAS WELL FIXED THE SURGEON DECIDED TO CONVERT IT TO A CA HEAD TO GIVE THE PATIENT A MINIMAL AMOUNT OF MOVEMENT. THE POLY WAS REMOVED, AND CUP WAS CLEANED THEN A 42 INSERT WAS OPENED IN WHICH THE SURGEON COULD NOT GET THE CA INSERT TO A COUPLE WITH THE AR-9502F-42CPC ARTHREX UNIVERS REVERS SUTURE CUP. A NEW AR-9502F-42CPC ARTHREX UNIVERS REVERS SUTURE CUP WAS OPENED AND WAS ATTEMPTED TO BE INSERTED AGAIN WITH NO AVAIL. A NEW INSERT WAS OPENED, WHICH PHYSICALLY, IT LOOKED DIFFERENT, IT WAS SLIGHTLY BIGGER AND WOULD NOT ALLOW TO SEAT INTO THE CUP. FINALLY, A 93 CUP OF A 39 INSERT WAS ABLE TO WORK. THIS WAS DISCOVERED DURING A REVISION REVERS SURGERY ON (B)(6) 2025. ADDITIONAL INFORMATION REQUESTED ON 2/28/2025.
Patient problems: Insufficient Information
MAUDE report 21606720 ↗
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- 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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