Arthrex® AR-9504MRecalls & reported problems
Arthrex, Inc. · UNIVERS REVERS GLENO 39 · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888867061354), received between Mar 21, 2019 and Apr 28, 2023 — classified as 2 injuries, 1 malfunction.
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
- Device Dislodged or Dislocated1
- Material Protrusion/Extrusion1
Patient problems
- Failure of Implant1
- Foreign Body In Patient1
- Insufficient Information1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 28, 2023Break; Break
IT WAS REPORTED THAT DURING A SURGERY FOR THE DISLOCATED EPIPHYSE THE 135° SCREW BROKE OFF. NO FURTHER INFORMATION RECEIVED. (B)(6) 2023, UPDATE DW. FURTHER INFORMATION WAS PROVIDED THAT THE PATIENT WAS TREATED WITH AN ARTHREX IMPLANT IN THE PAST. THE PATIENT SUFFERED AN INJURY WHICH RESULTED IN AN DISLOCATED PROSTHESIS CUP. DURING THE SURGERY ON 24TH FEBRUARY IT WAS THEN NOTICED THAT SCREW WHICH WAS PLACED AT 135° WAS BROKEN OFF. THE SURGEON THEN MOVED THE CUB AND FIXATED THE SCREW AT 155° AND THE BROKEN SCREW WAS NOT REMOVED.
Patient problems: Failure of Implant; Foreign Body In Patient
MAUDE report 16838020 ↗InjuryApr 7, 2021Material Protrusion/Extrusion
IT WAS REPORTED THAT A REVISION WAS NECESSARY AFTER A DISTAL PROTRUSION OF THE LONG HUMERAL SHAFT. THE PATIENT WILL BE REHABILITATED AT A LATER DATE AFTER A HUMERAL BONE GRAFTING PROCEDURE. THE BASE PLATE INCLUDING SCREWS HAVE REMAINED IN THE PATIENT. NO FURTHER INFORMATION WERE PROVIDED.
Patient problems: Insufficient Information
MAUDE report 11630386 ↗InjuryMar 21, 2019Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT UNDERWENT A TSA PROCEDURE ON (B)(6) 2018. 9 MONTHS POST-OP, ON (B)(6) 2019, THE PATIENT WAS SEEN BY THEIR SURGEON FOR A FOLLOW-UP VISIT WHERE AN X-RAY WAS TAKEN TO DETERMINE PROGRESS. THE X-RAY SHOWED THAT THE BASEPLATE AND GLENOSPHERE WERE DISLOCATED. THE PATIENT STATED THAT NO TRAUMA HAD OCCURRED. A COPY OF THE X-RAY IS UNABLE TO BE OBTAINED. A REVISION SURGERY TOOK PLACE ON (B)(6) 2019 AND THE FOLLOWING DEVICES WERE ALL EXPLANTED: AR-9145-30 / LOT: 170156313, AR-9145-36 / LOT: 170139313, AR-9504M / LOT: 140119609, AR-9503M-06 / LOT: 160010109, AR-9120-01 / LOT: 170145515, AND AR-9165-20 / LOT: 150008108. THE SURGEON SWITCHED TO AN RTSA AND IMPLANTED THE FOLLOWING: AR-9502-39ARCA / LOT: 261519 AND AR-9550-19RCA / LOT: 10031668. ADDITIONAL INFORMATION PROVIDED 3/29/2019: THE AR-9145-30 SCREW BROKE UPON REMOVAL OF HARDWARE. TIP WAS RETRIEVED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8440380 ↗
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- DJO SURGICAL 508-32-104Encore Medical, L.P. · shoulder prosthesis, reverse configuration1 recall203 reports
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- 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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