EXPLOR 11-210064Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00880304210479), received between Oct 27, 2020 and Apr 4, 2025 — classified as 5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryApr 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN IN THE WRIST APPROXIMATELY TWO MONTHS POST IMPLANTATION. THE PATIENT UNDERWENT ULNA SHORTENING OSTEOTOMY PROCEDURE AS A TREATMENT FOR PAIN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Pain

  MAUDE report 21772977 ↗
• 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 19656329 ↗
• InjuryJul 2, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN AND CREPITATION IN ELBOW AT APPROXIMATELY 2.5 YEARS POST OP. RADIOLOGY SHOWED LOOSENING OF THE STEM AND THE PATIENT WAS REVISED. ATTEMPTS HAVE BEEN MADE AND THERE IS NO FURTHER INFORMATION AT THIS TIME.

  Patient problems: Failure of Implant; Pain

  MAUDE report 19654727 ↗
• InjuryOct 23, 2023Detachment of Device or Device Component; Material Deformation; Patient Device Interaction Problem; Detachment of Device or Device Component; Material Deformation; Patient Device Interaction Problem

  IT WAS FURTHER REPORTED THAT THE PATIENT WAS EXPERIENCING PAIN AND LOSS OF RANGE OF MOTION DUE TO THE DISASSOCIATION.

  Patient problems: Failure of Implant; Loss of Range of Motion; Metal Related Pathology; Pain

  MAUDE report 17985625 ↗
• InjuryOct 27, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Pain

  MAUDE report 10743883 ↗

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.