EXPLOR 11-210041Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00880304438323), received between Aug 1, 2025 and Aug 1, 2025 — classified as 2 injuries.

The most frequently reported specific device problem is “Corroded” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryAug 1, 2025Corroded; Corroded

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL ELBOW ARTHROPLASTY APPROXIMATELY FOUR (4) YEARS AND SIX (6) MONTHS AGO. SUBSEQUENTLY, THE PATIENT UNDERWENT A REVISION SURGERY DUE TO SOFT TISSUE METALLOSIS AND DESTRUCTION OF THE CAPITULUM HUMERI SURFACE.

  Patient problems: Metal Related Pathology

  MAUDE report 22689113 ↗
• InjuryAug 1, 2025Corroded; Corroded

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL ELBOW ARTHROPLASTY APPROXIMATELY FOUR (4) YEARS AGO. SUBSEQUENTLY, THE PATIENT THE PATIENT UNDERWENT A REVISION SURGERY ON AN UNKNOWN DATE DUE TO SOFT TISSUE METALLOSIS AND DESTRUCTION OF THE CAPITULUM HUMERI SURFACE.

  Patient problems: Metal Related Pathology

  MAUDE report 22687266 ↗

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.