EXPLOR 11-210062Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00880304210455), received between Jan 13, 2023 and Aug 6, 2025 — classified as 5 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (3 reports).

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryAug 6, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Insufficient Information; Loss of Range of Motion; Pain

  MAUDE report 22729528 ↗
• InjuryApr 17, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL ELBOW IMPLANTATION APPROXIMATELY ONE (1) YEAR AGO AFTER EXPERIENCING AN ISOLATED, COMMINUTED FRACTURE OF THE RADIAL HEAD TWO (2) DAYS PRIOR. SUBSEQUENTLY, THE PATIENT UNDERWENT A REVISION APPROXIMATELY ELEVEN (11) MONTHS POST-IMPLANTATION DUE TO LOOSENING OF THE RADIAL HEAD PROSTHESIS. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Failure of Implant; Scar Tissue

  MAUDE report 21860662 ↗
• InjuryMar 17, 2025Fracture; Loosening of Implant Not Related to Bone-Ingrowth; Fracture; Loosening of Implant Not Related to Bone-Ingrowth

  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: Aseptic loosening; Failure of Implant

  MAUDE report 21625577 ↗
• InjuryJun 17, 2024Adverse 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: Nausea; Pain; Swelling/ Edema

  MAUDE report 19547453 ↗
• InjuryJan 13, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS FURTHER REPORTED THAT THE REVISION HAS TAKEN PLACE APPROXIMATELY A MONTH AGO.

  Patient problems: Failure of Implant

  MAUDE report 16158401 ↗

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.