DELTA XTEND 2307-82-003Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10603295116356), received between Aug 18, 2017 and May 20, 2022 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Naturally Worn” (4 reports).

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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 20, 2022Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT INSTRUMENTS WERE HIGHLY WORN AND NEEDED TO BE REPLACED. THERE WAS NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14462793 ↗
• MalfunctionMay 20, 2022Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT INSTRUMENTS WERE HIGHLY WORN AND NEEDED TO BE REPLACED. THERE WAS NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14462639 ↗
• MalfunctionJun 28, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE CTA REAMER WAS WELDED ONTO THE REAMER GUIDE. SURGERY WAS NOT EXTENDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12080834 ↗
• MalfunctionApr 8, 2021Device-Device Incompatibility; Device-Device Incompatibility

  SURGEON HAD CONVERTED TO EXTEND CTA DUE TO POOR GLENOID BONE QUALITY. WHEN HE ATTEMPTED TO PUT DELTA EXTEND CTA HEAD REAMER INTO THE REAMER GUIDE IT WOULD NOT FIT IN ALL THE WAY. SURGEON ATTEMPTED TO BEGIN REAMING AND IT STUCK AND ROTATED THE WHOLE CONSTRUCT, STEM, HEAD REAMER GUIDE AN REAMER. SURGICAL DELAY 10 MINUTES. SURGEON COMPLETED BONE REMOVAL WITH RONGEUR, PROCEDURE SUCCESSFULLY COMPLETED. NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11633357 ↗
• MalfunctionOct 9, 2019Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE LINER TRIAL WAS CRACKED AND WON¿T TRIAL THE HEAD CORRECTLY DUE TO CRACKED. THE CTA GUIDE AND THE REAMER HAVE BURRS INTERNALLY WHERE THEY MEET TOGETHER AND THEY BIND UP WHEN PUT TOGETHER. TOLERANCES ARE NOT CORRECT. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9171980 ↗
• InjuryJan 16, 2019Device-Device Incompatibility; Naturally Worn; Adverse Event Without Identified Device or Use Problem; Device-Device Incompatibility; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  DURING PREPARATION OF THE PROXIMAL HUMERUS FOR THE CTA HEAD THE REAMER GUIDE WAS MOUNTED ON TO THE HUMERAL STEM. WHILE REAMING WITH THE CTA-HEAD-REAMER, THE REAMER SUDDENLY BLOCKED IN THE REAMER-GUIDE. THIS TURNED PRESSURE ON THE HUMERAL STEM AND GENERATED A FRACTURE OF THE PROXIMAL HUMERUS. THIS FRACTURE HAD TO BE FIXED WITH SUTURES. THE OPERATION COULD BE COMPLETED.

  Patient problems: Bone Fracture(s); Not Applicable

  MAUDE report 8252956 ↗
• MalfunctionAug 18, 2017Connection Problem; Mechanical Jam; Connection Problem; Mechanical Jam

  IT WAS REPORTED THAT THE SURGEON ATTEMPTED TO IMPLANT AN XTEND CTA HEAD. WHEN REAMING THE LATERAL PROXIMAL HUMERUS, THE REAMER GOT STUCK ON THE GUIDE AND COULD NOT BE REMOVED.

  Patient problems: No Information

  MAUDE report 6805001 ↗