EXPLOR 11-210042Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00880304438309), received between Feb 21, 2023 and Jul 17, 2025 — classified as 6 injuries.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).

2 other recalls cover devices cleared under the same FDA submission (K040611, K051385); they may or may not involve this specific model.

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryJul 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Aseptic loosening; Loss of Range of Motion; Pain

  MAUDE report 22538413 ↗
• InjuryMar 17, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED WITH A PROSTHESIS. SUBSEQUENTLY, THE PATIENT SUFFERED A FRACTURE AND THE IMPLANT BECAME LOOSE. THERE WAS HARM TO THE PATIENT AS THE PATIENT HAD TO UNDERGO ADDITIONAL SURGICAL/MEDICAL PROCEDURE. DUE DILIGENCE IS COMPLETE. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant

  MAUDE report 21625567 ↗
• InjuryJul 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED LOSS OF RANGE OF MOTION AND STIFFNESS 3 MONTHS POST OPERATION. THERE WAS NO SUPINATION, TOTAL ROM 35 DEGREES EXT/FLEX, AND ARTHROSIS OPEN SURGERY WITH BONE EXICISION. THE PATIENT RECEIVED REOPERATION FOR THESE ISSUES. ATTEMPTS HAVE BEEN MADE AND THERE IS NO FURTHER INFORMATION AT THIS TIME.

  Patient problems: Extraskeletal ossification; Loss of Range of Motion

  MAUDE report 19656324 ↗
• InjuryJul 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT EXPERIENCED PAIN AND STIFFNESS WHICH LED TO THE REMOVAL OF THE IMPLANTS. ATTEMPTS HAVE BEEN MADE AND THERE IS NO FURTHER INFORMATION AT THIS TIME.

  Patient problems: Pain

  MAUDE report 19650871 ↗
• InjuryDec 21, 2023Detachment of Device or Device Component; Patient Device Interaction Problem; Detachment of Device or Device Component; Patient Device Interaction Problem

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Failure of Implant; Metal Related Pathology

  MAUDE report 18372720 ↗
• InjuryFeb 21, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO LOOSE SCREW IN THE RADIAL HEAD. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.

  Patient problems: Failure of Implant

  MAUDE report 16408062 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K040611, K051385. One submission often covers many models, so check the product and lot details in each record.

• Z-0269-2018 · Jun 16, 2017 · Terminated
  ExploR Radial Head Replacement System. PN: 11-210061 LN: 243610. The stem is placed inside a polyurethane bag. The bagged component will then be placed in an inner PETG tray. The
• Z-1615-2014 · Apr 22, 2014 · Terminated
  ExploR 7x26mm Modular Radial Stem, Catalog number 11-210062. Elbow prosthesis orthopedic implant.