DELTA XTEND 1307-38-703Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295027485), received between Aug 8, 2023 and May 19, 2025 — classified as 2 injuries.

2 other recalls cover devices cleared under the same FDA submission (K091751, K120174); 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. 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMay 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD INFECTION AND POLY SWAP AND WASHOUT. WENT FROM 38 +3 STANDARD TO A +9 SPACER AND 38 +3 STANDARD POLY. SURGICAL DELAY WAS UNKNOWN. DOI: UNKNOWN, DOR: (B)(6) 2025 AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Unspecified Infection

  MAUDE report 22045069 ↗
• InjuryAug 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A RIGHT DELTA XTEND REVERSE SHOULDER REPLACEMENT APPROXIMATELY 6 MONTHS AGO. PATIENT REPRESENTED TO SURGEON COMPLAINING OF PAIN, UNEXPLAINED ORIGIN. PROCEDURE; FIRST STAGE REVISION OF ALL COMPONENTS AND INSERTION OF GLOBAL AP HEMIARTHROPLASTY CEMENT 'SPACER'. UPON OPENING THE SHOULDER AND EXAMINING THE JOINT THE SURGEON SUSPECTED A LOW GRADE INFECTION WAS PRESENT. MULTIPLE SPECIMENS AND SWABS WERE TAKEN. DOI: UNKNOWN. DOE: (B)(6) 2023. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 17480065 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K091751, K120174. One submission often covers many models, so check the product and lot details in each record.

• Z-0834-2018 · Aug 31, 2017 · Terminated
  DELTA XTEND" Reverse Shoulder System Modular Centered and Eccentric Epiphysis Implants intended for use in total shoulder or hemi-shoulder replacement procedures in patients with n
• Z-0833-2018 · Aug 31, 2017 · Terminated
  DELTA XTEND" Reverse Shoulder System Modular Centered and Eccentric Epiphysis Implants are intended for use in total shoulder or hemi-shoulder replacement procedures in patients wi