DELTA XTEND 140760025Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10603295423652), received between Sep 1, 2017 and May 1, 2026 — classified as 9 injuries.

The most frequently reported specific device problem is “Loss of Osseointegration” (2 reports).

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 16, 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.

• InjuryMay 1, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REMOVAL OF ALL GLENOID IMPLANTS AND IMPLANTATION OF A CTA HEAD ONTO THE STEM DUE TO INFECTION. DOI: UNKNOWN. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Unspecified Infection

  MAUDE report 25059197 ↗
• InjuryNov 12, 2025Osseointegration Problem; Osseointegration Problem

  PATIENT WAS REVISED DUE TO BASEPLATE CAME LOOSE. DOCTOR DID THE ORIGINAL CASE WITH BONE GRAFT BEHIND THE METAGLEEN AND IF FAILED. HE REVISED IT TO A CTA HEMI AND REMOVED THE BASE PLATE AND POLY. DOI: (B)(6) 2022. DOR: UNKNOWN. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Inadequate Osseointegration

  MAUDE report 23531661 ↗
• InjuryJan 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INSTABILITY. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: UNKNOWN SHOULDER.

  Patient problems: Joint Laxity

  MAUDE report 18483541 ↗
• InjuryJun 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO A +15 LONG PEGGED METAGLENE, 3 SCREWS THROUGH BASEPLATE, A 42 STANDARD GLENOSPHERE, AND A 42/+3 POLY. THE ENTIRE HUMERAL STEM WAS RETAINED AND NOT CHANGED. UNFORTUNATELY HE IS CONFIRMED FOR AN INFECTION IN SURGERY TODAY. ALL PARTS AND PIECES WERE REMOVED FROM THE PATIENT AND AN ANTIBIOTIC SPACER WAS PLACED TO TREAT THE INFECTION. DOI: ON (B)(6) 2020, DOR: ON (B)(6) 2023, AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Unspecified Infection

  MAUDE report 17144483 ↗
• InjurySep 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INSTABILITY. DOI: UNKNOWN, DOR: (B)(6) 2020, UNKNOWN AFFECTED SIDE.

  Patient problems: No Code Available

  MAUDE report 10509727 ↗
• InjurySep 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INSTABILITY. NO SURGICAL DELAY IS NOTED. DOI: (B)(6) 2020. DOR: (B)(6) 2020; RIGHT SHOULDER.

  Patient problems: No Code Available

  MAUDE report 10491937 ↗
• InjuryNov 26, 2019Loss of Osseointegration; Osseointegration Problem; Loss of Osseointegration; Osseointegration Problem

  THE PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE METAGLENE AT THE BONE TO IMPLANT INTERFACE. A FAILED GLENOID REVISION RECONSTRUCTION CONVERTED TO DELTA CTA . DOI: (B)(6) 2019; DOR: (B)(6) 2019; RIGHT SHOULDER.

  Patient problems: Inadequate Osseointegration; No Code Available

  MAUDE report 9377570 ↗
• InjuryJun 15, 2018Migration or Expulsion of Device; Migration or Expulsion of Device

  DER STATES THAT THE PATIENT HAD A DELTA REVERSE SHOULDER IMPLANTED APPROXIMATELY 2 YEARS AGO AND RECENTLY BEGAN TO EXPERIENCE PAIN AND DISCOMFORT IN HER SHOULDER. SURGEON EVALUATED THE PATIENT AND FOUND OUT THAT THE X-RAY¿S INDICATED THAT THE METAGLENE BASE PLATE WAS LOOSE, A BASE PLATE SCREW WAS BROKEN, AND THIS PATIENT WOULD NEED A REVISION. SURGEON WAS ASKED WHY HE THOUGHT THE METAGLENE CAME LOOSE AND HE SUSPECTED THAT DUE TO THE PATIENT USING HER ARM TO WALK WITH A CANE AND WALKER BECAUSE PATIENT RECENTLY HAD A KNEE REPLACEMENT. DURING THE REVISION SURGERY, SURGEON SAID THE COMPONENTS WEREN¿T REALLY LOOSE AND THAT THE BASE PLATE HAD MIGRATED DUE TO THE POOR BONE QUALITY. THE GLENOID WAS BONE GRAFTED AND A NEW METAGLENE, 4 SCREWS, GLENOSPHERE, AND HUMERAL CUP WERE IMPLANTED. DOI: APPROXIMATELY 2 YEARS AGO; DOR: (B)(6) 2018; RIGHT SHOULDER.

  Patient problems: Discomfort; Not Applicable; Pain

  MAUDE report 7605439 ↗
• InjurySep 1, 2017Loss of Osseointegration; Loss of Osseointegration

  DER STATES PATIENT HAD RIGHT REVERSE TSA LAST YEAR AND WENT TO DOCTOR BECAUSE HE SAID HE MOVED HIS SHOULDER AND HEARD A "POP" AND FELT PAIN. SURGEON TOOK X-RAYS AND SAW A BROKEN SCREW AND METAGLENE HAD COME LOOSE AT THE BONE TO IMPLANT INTERFACE.

  Patient problems: Pain

  MAUDE report 6838244 ↗

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