Arthrex® AR-9503S-06CRecalls & reported problems
Arthrex, Inc. · HUM INSERT S/36+6 TO FIT IN 36 CUP CONST · 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 00888867061323), received between May 14, 2020 and May 14, 2020 — classified as 1 injury.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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
- Device Dislodged or Dislocated1
Patient problems
- Failure of Implant1
- Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMay 14, 2020Device Dislodged or Dislocated
IT WAS REPORTED THAT A REVISION WAS NEEDED; THE ORIGINAL DOS WAS (B)(6) 2019 (NO EXACT DATE KNOWN), THE CASE WAS A REVERSE SHOULDER WITH MODULAR GLENOID SYSTEM. THE PATIENT WAS EXPERIENCING PAIN AND X-RAY SHOWED THAT THE WHOLE CONSTRUCT HAS DISLOCATED. IT IS NOT KNOWN IF THE PATIENT WAS NON-COMPLIANT. ON (B)(6) 2020, THEY REMOVED AR-9503S-06C HUMERAL INSERT; IT WAS THE ONLY PART FROM THE ORIGINAL SURGERY THAT WAS REMOVED; IT WAS REPLACED WITH AR-9555-06 REVERS SPACER AND AR-9503S-03C HUMERAL INSERT. PATIENT IS MALE, (B)(6) YEARS.
Patient problems: Failure of Implant; Pain
MAUDE report 10055548 ↗
Other shoulder prosthesis, reverse configuration devices
- DJO SURGICAL 508-36-101Encore Medical, L.P. · shoulder prosthesis, reverse configuration508 reports
- 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.
How reports and recalls are matched · Editorial policy · Report an error on this page