DELTA XTEND 1307-20-111Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10603295510215), received between May 11, 2023 and Sep 17, 2026 — classified as 8 injuries.

The most frequently reported specific device problem is “Osseointegration Problem” (3 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjurySep 17, 2026Osseointegration Problem

  Patient problems: Inadequate Osseointegration; Unspecified Infection

  MAUDE report 50807367 ↗
• InjuryJan 26, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD INCREASED PAIN DUE TO HUMERAL FRACTURE. SURGEON REMOVED A SIZE 10 GLOBAL UNITE STEM, 145 SIZE 1 CENTERED EPIPHYSIS, AND A 38 +3 STANDARD HUMERAL CUP. SURGEON THEN CEMENTED A SIZE 10 GLOBAL UNITE REVISION STEM, 145 SIZE 1 CENTERED EPIPHYSIS, AND A 38 +3 STANDARD HUMERAL CUP. DOI: (B)(6) 2025. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Bone Fracture(s); Pain

  MAUDE report 24179931 ↗
• InjuryJan 6, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. IT WAS STATED THAT THE METEGLENE WAS LOOSE. LOOSENING INTERFACE WAS MARKED AS BONE TO IMPLANT INTERFACE. NO ADDITIONAL INFORMATION. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT.

  Patient problems: Unspecified Infection

  MAUDE report 23976173 ↗
• InjuryJun 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S SHOULDER BECAME INFECTED AND HARDWARE NEEDED TO BE REMOVED. DOI: (B)(6) 2022. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Unspecified Infection

  MAUDE report 22160845 ↗
• InjuryJan 8, 2025Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE PATIENT CONTRACTED AN INFECTION, SO ALL IMPLANTS WERE REMOVED AND A ANTIBIOTIC SPACER WAS PUT IN PLACE. THERE WAS STEM LOOSENING AT NON-CEMENT INTERFACE. SURGICAL DELAY WAS UNKNOWN. DOI: (B)(6) 2024. DOE: (B)(6) 2024. AFFECTED SIDE: UNKNOWN.

  Patient problems: Inadequate Osseointegration; Unspecified Infection

  MAUDE report 21104835 ↗
• InjuryJul 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED: A. WHAT WAS THE PRIMARY REASON FOR REVISION? WAS IT PAIN OR INFECTION OR INSTABILITY? B. WAS THE PATIENT REVISED FOR PAIN AND INFECTION FOUND UPON REVISION ? OR INFECTION WAS FOUND EARLIER? "IT WAS REVISED FOR PAIN AND FOUND INTRAOPERATIVELY TO BE GROSSLY INFECTED."

  Patient problems: Joint Laxity; Pain; Unspecified Infection

  MAUDE report 19781855 ↗
• InjuryOct 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT UNDERWENT A RIGHT DELTA XTEND REVISION FOR INFECTION. ALL COMPONENTS REMOVED AND CEMENT SPACER PUT IN. PROCEDURE SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. DATE OF ORIGINAL SURGERY WAS (B)(6) 2023.

  Patient problems: Unspecified Infection

  MAUDE report 17894120 ↗
• InjuryMay 11, 2023Osseointegration Problem; Osseointegration Problem

  PATIENT REVISED DUE TO STEM LOOSENED. NO SURGICAL DELAY WAS THERE. DOI: (B)(6) ,2021. DOR: (B)(6) ,2023. AFFECTED SIDE: UNKNOWN.

  Patient problems: Inadequate Osseointegration

  MAUDE report 16910013 ↗