Arthrex® AR-9503M-03CRecalls & reported problems
Arthrex, Inc. · HUM INSERT M/39+3 TO FIT IN 39 CUP CONST · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867061262), received between Dec 2, 2020 and Apr 26, 2024 — classified as 1 injury, 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
- Appropriate Device Problem Term/Code Not Available1
- Defective Device1
- Device Dislodged or Dislocated1
Patient problems
- Failure of Implant1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 26, 2024Defective Device; Defective Device
ON (B)(6) /2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT (2) AR-9503M-03C HUMERAL INSERTS ARE DAMAGED. THIS WAS DISCOVERED DURING AN UNSPECIFIED TIME, WITH NO PATIENT EFFECT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19193722 ↗InjuryDec 2, 2020Device Dislodged or Dislocated; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THROUGH THE SURGICAL OUTCOME SYSTEM THAT A PATIENT COMPLICATION OCCURRED THAT WAS POSSIBLY RELATED TO AN ARTHEX PRODUCT. UPON FURTHER INVESTIGATION THE FOLLOWING WAS DISCOVERED: PATIENT UNDERWENT AN (B)(6) 2019 SHOULDER PROCEDURE. THE PATIENT HAD A POST-OPERATIVE DISLOCATION RESULTING IN A (B)(6) 2019 REVISION SURGERY. DURING THE REVISION PROCEDURE THE FOLLOWING ARTHREX DEVICES WERE EXPLANTED: AR-9503M-03C /HUMERAL INSERT AND AR-9505-15 /UNIVERS REVERSE SPACER. TO COMPLETE THE REVISION PROCEDURE THE SURGEON IMPLANTED THE FOLLOWING TWO ARTHREX DEVICES: AR-9503M-06 /HUMERAL INSERT AND AR-9505-15 /UNIVERS REVERSE SPACER.
Patient problems: Failure of Implant
MAUDE report 10934380 ↗
Other shoulder prosthesis, reverse configuration devices
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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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