DELTA XTEND 1407-60-010Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10603295272908), received between Sep 12, 2017 and Jun 2, 2025 — classified as 6 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).

2 other recalls cover devices cleared under the same FDA submission (K120174, K192448, K192855); 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryJun 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD C. ACNES INFECTION AS WELL AS PAIN AND JOINT INSTABILITY. THIS IS PATIENT'S SECOND REVISION. THIS REPORT IS FOR THE SECOND REVISION PROCEDURE. THE FIRST REVISION IS CAPTURED ON RELATED COMPLAINT (B)(4).

  Patient problems: Joint Laxity; Pain; Unspecified Infection

  MAUDE report 22125137 ↗
• InjuryDec 22, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS TREATED WITH A RIGHT SHOULDER PROSTHETICS ON THE (B)(6) 2020 DUE TO AN UNKNOWN REASON. DURING RECOVERY THE PATIENT RECEIVED A CLOSED REDUCTION TO TREAT A PAIN AND INSTABILITY SECONDARY TO A DISLOCATION CAUSED BY A FALL. THE RECOVERY COURSE HAS BEEN COMPLICATED BY A COVID INFECTION. THE PATIENT WILL BE REVISED IN (B)(6) 2021 AFTER A NICKEL FREE IMPLANT IS RECEIVED DUE TO THE PATIENT'S NICKEL ALLERGY.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Fall; Joint Laxity; Loss of Range of Motion; Pain; Pneumonia

  MAUDE report 11056748 ↗
• InjuryAug 14, 2020Loss of Osseointegration; Loss of Osseointegration

  PATIENT WITH DELTA XTEND IMPLANTS INSITU, FRACTURED SCAPULA RESULTING IN LOOSE METAGLENE AND GLENOSPHERE. PATIENT HAS RHEUMATOID ARTHRITIS AND IDENTIFIED BY THE SURGEON TO HAVE POOR BONE QUALITY WHICH HE FEELS CONTRIBUTED TO THE IMPLANT FAILING.

  Patient problems: Bone Fracture(s); Inadequate Osseointegration; Injury; No Code Available

  MAUDE report 10410919 ↗
• InjuryJul 6, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION OF DELTA XTEND REVERSE SHOULDER REPLACEMENT. PT HAD A FALL AND WAS EXPERIENCING INSTABILITY AND PAIN. X-RAY SHOWED DISPLACEMENT OF STEM. ALL IMPLANTS REMOVED FROM PT, NO IMPLANTS PLACED BACK IN.

  Patient problems: Fall; No Code Available; Pain

  MAUDE report 10237680 ↗
• InjuryJun 8, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AFFECTED SIDE IS THE LEFT.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10130075 ↗
• InjurySep 12, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS REVISED TO ADDRESS INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 6857493 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K120174, K192448, K192855. One submission often covers many models, so check the product and lot details in each record.

• 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
• 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