Arthrex® AR-14238Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888867017382), received between Dec 26, 2025 and Dec 26, 2025 — classified as 3 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (3 reports).

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

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryDec 26, 2025Device Dislodged or Dislocated; Loosening of Implant Not Related to Bone-Ingrowth; Device Dislodged or Dislocated; Loosening of Implant Not Related to Bone-Ingrowth

  ADDITIONAL INFORMATION WAS RECEIVED ON (b)(6) 2026:ON (b)(6) 2025, THE FAILED PROXIMAL HUMERAL PLATE WAS INITIALLY IDENTIFIED DURING A CLINIC VISIT. A REVISION SURGERY WAS PERFORMED, DURING WHICH THE PREVIOUSLY IMPLANTED DEVICES WERE REMOVED. PER COMMUNICATION FROM THE OPERATIVE SURGEON WHO PERFORMED THE REVISION PROCEDURE, THE BUSHINGS WERE OBSERVED TO HAVE DISENGAGED FROM THE PLATE. ADDITIONAL INFORMATION WAS RECEIVED ON (b)(6) 2026:ALL IMPLANTED ARTHREX DEVICES FROM THE REVISION PROXIMAL HUMERUS ORIF PERFORMED ON (b)(6) 2025 WERE EXPLANTED DURING A SUBSEQUENT REVISION PROXIMAL HUMERUS PROCEDURE WITH PLACEMENT OF A SPACER ON (b)(6) 2026. NO ARTHREX IMPLANTS WERE IMPLANTED DURING THE (b)(6) 2026 PROCEDURE. THE REVISION PROCEDURE WAS PERFORMED AT THE SAME FACILITY AS THE PRIOR REVISION PROXIMAL HUMERUS ORIF CONDUCTED ON (b)(6) 2025; HOWEVER, THE PROCEDURE WAS PERFORMED BY A DIFFERENT SURGEON. THE PATIENT¿S CURRENT CONDITION WAS REPORTED AS STABLE. THE SALES REPRESENTATIVE WAS NOT PRESENT FOR THE (b)(6) 2026 SURGERY AND REPORTED BEING INFORMED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PATIENT IS SCHEDULED TO UNDERGO A TOTAL SHOULDER REPLACEMENT IN MAY.ADDITIONAL INFORMATION

  Patient problems: Failure of Implant; Nonunion/Delayed-union Bone Fracture

  MAUDE report 23897575 ↗
• InjuryDec 26, 2025Device Dislodged or Dislocated; Loosening of Implant Not Related to Bone-Ingrowth; Device Dislodged or Dislocated; Loosening of Implant Not Related to Bone-Ingrowth

  ADDITIONAL INFORMATION WAS RECEIVED ON (b)(6) 2026:ON (b)(6) 2025, THE FAILED PROXIMAL HUMERAL PLATE WAS INITIALLY IDENTIFIED DURING A CLINIC VISIT. A REVISION SURGERY WAS PERFORMED, DURING WHICH THE PREVIOUSLY IMPLANTED DEVICES WERE REMOVED. PER COMMUNICATION FROM THE OPERATIVE SURGEON WHO PERFORMED THE REVISION PROCEDURE, THE BUSHINGS WERE OBSERVED TO HAVE DISENGAGED FROM THE PLATE. ADDITIONAL INFORMATION WAS RECEIVED ON (b)(6) 2026:ALL IMPLANTED ARTHREX DEVICES FROM THE REVISION PROXIMAL HUMERUS ORIF PERFORMED ON (b)(6) 2025 WERE EXPLANTED DURING A SUBSEQUENT REVISION PROXIMAL HUMERUS PROCEDURE WITH PLACEMENT OF A SPACER ON (b)(6) 2026. NO ARTHREX IMPLANTS WERE IMPLANTED DURING THE (b)(6) 2026 PROCEDURE. THE REVISION PROCEDURE WAS PERFORMED AT THE SAME FACILITY AS THE PRIOR REVISION PROXIMAL HUMERUS ORIF CONDUCTED ON(b)(6) 2025; HOWEVER, THE PROCEDURE WAS PERFORMED BY A DIFFERENT SURGEON. THE PATIENT¿S CURRENT CONDITION WAS REPORTED AS STABLE. THE SALES REPRESENTATIVE WAS NOT PRESENT FOR THE (b)(6) 2026 SURGERY AND REPORTED BEING INFORMED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PATIENT IS SCHEDULED TO UNDERGO A TOTAL SHOULDER REPLACEMENT IN MAY.ADDITIONAL INFORMATION

  Patient problems: Failure of Implant; Nonunion/Delayed-union Bone Fracture

  MAUDE report 23897496 ↗
• InjuryDec 26, 2025Device Dislodged or Dislocated; Loosening of Implant Not Related to Bone-Ingrowth; Device Dislodged or Dislocated; Loosening of Implant Not Related to Bone-Ingrowth

  ADDITIONAL INFORMATION WAS RECEIVED ON (b)(6) 2026:ON (b)(6) 2025, THE FAILED PROXIMAL HUMERAL PLATE WAS INITIALLY IDENTIFIED DURING A CLINIC VISIT. A REVISION SURGERY WAS PERFORMED, DURING WHICH THE PREVIOUSLY IMPLANTED DEVICES WERE REMOVED. PER COMMUNICATION FROM THE OPERATIVE SURGEON WHO PERFORMED THE REVISION PROCEDURE, THE BUSHINGS WERE OBSERVED TO HAVE DISENGAGED FROM THE PLATE. ADDITIONAL INFORMATION WAS RECEIVED ON (b)(6) 2026:ALL IMPLANTED ARTHREX DEVICES FROM THE REVISION PROXIMAL HUMERUS ORIF PERFORMED ON (b)(6) 2025 WERE EXPLANTED DURING A SUBSEQUENT REVISION PROXIMAL HUMERUS PROCEDURE WITH PLACEMENT OF A SPACER ON (b)(6) 2026. NO ARTHREX IMPLANTS WERE IMPLANTED DURING THE (b)(6)2026 PROCEDURE. THE REVISION PROCEDURE WAS PERFORMED AT THE SAME FACILITY AS THE PRIOR REVISION PROXIMAL HUMERUS ORIF CONDUCTED ON (b)(6) 2025; HOWEVER, THE PROCEDURE WAS PERFORMED BY A DIFFERENT SURGEON. THE PATIENT¿S CURRENT CONDITION WAS REPORTED AS STABLE. THE SALES REPRESENTATIVE WAS NOT PRESENT FOR THE (b)(6) 2026 SURGERY AND REPORTED BEING INFORMED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PATIENT IS SCHEDULED TO UNDERGO A TOTAL SHOULDER REPLACEMENT IN MAY.ADDITIONAL INFORMATION

  Patient problems: Failure of Implant; Nonunion/Delayed-union Bone Fracture

  MAUDE report 23896446 ↗