Arthrex® AR-9555-12Recalls & reported problems
Arthrex, Inc. · UNIVERS REVERS SPACER 36+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 00888867062498), received between Feb 11, 2025 and Feb 11, 2025 — 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.
Reports received per month
Most reported problems
Device problems
- Break1
Patient problems
- Aseptic loosening1
- Bone Fracture(s)1
- Failure of Implant1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryFeb 11, 2025Break; Break
ON (B)(6) 2024, A CLINDEX NOTIFICATION WAS RECEIVED INDICATING THAT A PATIENT LISTED ON THE SHOULDER ARTHROPLASTY REGISTRY EXPERIENCED LOOSENING OF THE GLENOID SIDE IMPLANTS ON (B)(6) 2024. ON (B)(6) 2024, THE PATIENT UNDERWENT REVISION SURGERY TO HAVE THE BASEPLATE REMOVED AND HAD A CTA HEAD IMPLANTED. THIS EVENT WAS INDICATED TO BE RELATED TO THE UNIVER REVERS IMPLANT SYSTEM IMPLANTED ON (B)(6) 2023. NO FURTHER INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION WAS RECEIVED ON 1/15/2025: THE PATIENT'S INITIAL PROCEDURE WAS ON (B)(6) 2023, AND AN ARTHREX UNIVERS REVERS SYSTEM WAS IMPLANTED. THE PATIENT SUFFERED A FALL AROUND (B)(6) 2023, RESULTING IN A MEDIAL BODY SCAPULAR FRACTURE. AN ORIF PROCEDURE WAS PERFORMED ON (B)(6) 2024. NO INFORMATION WAS PROVIDED REGARDING THE SURGERY ON (B)(6) 2024. A POST-OPERATIVE X-RAY AND CT ON (B)(6) 2024 CONFIRMED THAT THE MEDICAL ASPECT OF THE DURAL PLATING WAS INTACT, BUT THE PATIENT HAD A FRACTURE DISTALLY OVER THE ACROMION, WHICH HAD NOT HEALED. X-RAYS ON (B)(6)2024 ALSO CONFIRMED PROGRESSIVE LOOSENING OF THE PATIENT'S REVERSE PROSTHESIS, WITH A MARKEDLY ANTEVERTED GLENOID BASEPLATE. THE ACROMION BROKE OFF AND WAS SITTING IN THE SOFT TISSUES OF
Patient problems: Aseptic loosening; Bone Fracture(s); Failure of Implant
MAUDE report 21357526 ↗
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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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