EXPLOR 11-210063Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00880304210462), received between Mar 10, 2020 and Mar 30, 2026 — classified as 9 injuries.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryMar 30, 2026Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL LEFT ELBOW ARTHROPLASTY. SUBSEQUENTLY THE PATIENT WAS REVISED APPROXIMATELY 4 MONTHS AND 16 DAYS POST IMPLANTATION DUE TO LOOSENING, ECTOPIC BONE FORMATION, ARTHROLYSIS, AND PAIN. DURING THE REVISION NOTED SCAR TISSUE, IMPLANT ¿CATCHING¿ AND WEAR. THE HEAD WAS EXCHANGED FOR A SMALLER SIZE WITHOUT COMPLICATIONS.ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Aseptic loosening; Extraskeletal ossification; Joint Contracture; Loss of Range of Motion; Pain; Scar Tissue

  MAUDE report 24716380 ↗
• 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 22689111 ↗
• 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 22687256 ↗
• InjuryJul 17, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

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

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

  MAUDE report 22538414 ↗
• 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 19651278 ↗
• InjuryMar 4, 2024Detachment of Device or Device Component; Patient Device Interaction Problem; Detachment of Device or Device Component; Patient Device Interaction Problem

  IT WAS REPORTED THAT A EXPLORE RADIAL HEAD IMPLANT DISASSOCIATED FROM STEM AFTER 3 YEARS OF BEING IMPLANTED. THE SURGEON REVISED, TAKING THE DISSOCIATED HEAD OUT WHICH HAD THE SCREW IN IT. THE STEM WAS STABLE AND STAYED IN. HE CLEANED THE FEMALE THREADS CHECKED TO MAKE SURE THE THREADS WEREN'T STRIPPED BY USING A SCREW AND TORQUING ON IT. NOTHING WAS CROSS THREADED OR STRIPPED. HE THEN RETRIED AND IMPLANTED A NEW HEAD WITH A NEW SCREW. ATTEMPTS HAVE BEEN MADE AND THERE IS NO FURTHER INFORMATION AT THIS TIME.

  Patient problems: Failure of Implant; Metal Related Pathology

  MAUDE report 18826839 ↗
• InjurySep 21, 2023Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Noise, Audible; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Noise, Audible

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A TRAUMA PROCEDURE APPROXIMATELY SEVEN (7) YEARS AGO FOLLOWING A FALL THAT FRACTURED THE LEFT ULNAR AND RADIAL HEAD OF THE HUMERUS. SUBSEQUENTLY, THE PATIENT BEGAN EXPERIENCING PAIN, DECREASED ROM, SWELLING AND NOISE APPROXIMATELY FIVE (5) YEARS AND SIX (6) MONTHS POST-IMPLANTATION. X-RAY IMAGES WERE TAKEN AND REVEALED THE RADIAL HEAD HAD DISASSOCIATED FROM STEM AND PROGRESSION OF ARTHRITIS WAS NOTED. THE PATIENT LATER UNDERWENT A REVISION SURGERY APPROXIMATELY FOUR (4) MONTHS AGO. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Failure of Implant; Joint effusion; Loss of Range of Motion; Pain; Swelling/ Edema

  MAUDE report 17795189 ↗
• InjuryMay 17, 2023Adverse 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: Discomfort; Extraskeletal ossification; Joint Contracture; Loss of Range of Motion; Pain; Scar Tissue

  MAUDE report 16947510 ↗
• InjuryMar 10, 2020Unstable; Detachment of Device or Device Component; Loosening of Implant Not Related to Bone-Ingrowth; Unstable; Detachment of Device or Device Component; Loosening of Implant Not Related to Bone-Ingrowth

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

  Patient problems: Failure of Implant; Loss of Range of Motion; Pain

  MAUDE report 9810964 ↗

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.