Skip to content

DELTA XTEND 1407-60-015Recalls & reported problems

Depuy (Ireland) · DELTA XTEND REVERSE SHOULDER SYSTEM Cementless Metaglene +15mm HA COATED CEMENTLESS · Class 2 · Implant

All models of DELTA XTEND (194)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10603295272915), received between Apr 13, 2022 and Apr 13, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Osseointegration Problem” (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

Device problems

  • Osseointegration Problem1

Patient problems

  • Inadequate Osseointegration1
  • Inflammation1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryApr 13, 2022Osseointegration Problem; Osseointegration Problem

    PATIENT PREVIOUSLY HAD SHOULDER ARTHROPLASTY REVISION SURGERY FROM ANATOMIC TO REVERSE ON (B)(6) 2018. THEY USED A BIO RSA BONE GRAFT ON THE GLENOID SIDE DUE TO GLENOID BONE LOSS. THIS BONE GRAFT RESORBED AND SUBSEQUENTLY THE GLENOID FIXATION FAILED AND THE GLENOID COMPONENTS BECAME LOOSE. THIS RESULTED IN DISLOCATION. THE IMPLANTS HAVE ALL BE EXPLANTED AND SHOULDER FUSION PROCEDURE CARRIED OUT. THERE WERE SCREWS IN THE METAGLENE ALSO, HOWEVER I WAS UNABLE TO OBTAIN THE LOT NUMBERS AS THEY WERE UNREADABLE.

    Patient problems: Inadequate Osseointegration; Inflammation

    MAUDE report 14103498 ↗

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-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

Other PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED devices

All PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED devices →

Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page