DELTA XTEND 1307-64-038Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10603295502470), received between Jan 2, 2020 and Mar 31, 2026 — classified as 11 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryMar 31, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A REVISION SURGERY WAS COMPLETED BECAUSE OF INSTABILITY. GLENOSPHERE AND POLY CUP WERE REMOVED AND REPLACED WITH DIFFERENT SIZES. ORIGINAL DATE OF SURGERY IS UNKNOWN. AFFECTED SIDE: LEFT.

  Patient problems: Joint Laxity

  MAUDE report 24745208 ↗
• InjuryDec 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ALL IMPLANTS WERE REMOVED DUE TO INFECTION. AFFECTED SIDE- RIGHT SHOULDER.

  Patient problems: Unspecified Infection

  MAUDE report 23818683 ↗
• InjuryDec 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ALL IMPLANTS WERE REMOVED DUE TO INFECTION. AFFECTED SIDE- RIGHT SHOULDER.

  Patient problems: Unspecified Infection

  MAUDE report 23818664 ↗
• InjuryDec 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO INFECTION, SO SURGEON DECIDED TO REMOVED IMPLANTS AND PUT IN A HEMI SHOULDER. THERE WAS NO SURGICAL DELAY.

  Patient problems: Unspecified Infection

  MAUDE report 23815142 ↗
• InjuryJul 7, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WAS DISLOCATING, SO THE SURGEON DECIDED TO PUT IN A LARGER GLENOSPHERE, HUMERAL SPACER, AND A DIFFERENT POLYETHYLENE CUP. DOI: (B)(6) 2023. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Joint Dislocation

  MAUDE report 22412405 ↗
• InjuryNov 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON (B)(6) 2024, THE PATIENT WAS REVISED DUE TO INSTABILITY. UNKNOWN SURGICAL DELAY. DATE OF IMPLANT UNKNOWN.

  Patient problems: Joint Laxity

  MAUDE report 20712251 ↗
• InjuryAug 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT EVERYTHING WAS EXPLANTED AND SPACER PUT IN. DOI: (B)(6) 2022. DOR: (B)(6) 2022. AFFECTED SIDE: UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 19953222 ↗
• InjuryJan 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INSTABILITY. DOI: (B)(6) 2021 - DOR: (B)(6) 2021, (RIGHT SHOULDER).

  Patient problems: Joint Laxity

  MAUDE report 13178381 ↗
• InjuryAug 24, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED DUE TO CHRONIC DISLOCATIONS OF DELTA TSA. REVISED TWO PREVIOUS TIMES. CONVERTED TO DELTA CTA HEAD. NO OTHER INFORMATION IS AVAILABLE. DOI: (B)(6) 2021 (PE CUP AND GLENOSPHERE) DOR: (B)(6) 2021 RIGHT SHOULDER.

  Patient problems: Joint Dislocation

  MAUDE report 12359742 ↗
• InjuryAug 5, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED DUE TO DISLOCATED THE SHOULDER AFTER ROLLING OVER TO GET OUT OF BED. PATIENT WAS RETURNED TO THE OPERATING ROOM TO PLACE A THICKER MORE RETENTIVE POLY. DOI: (B)(6) 2021. DOR: (B)(6) 2021; LEFT SHOULDER.

  Patient problems: Joint Dislocation

  MAUDE report 12280939 ↗
• InjuryJul 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INSTABILITY. DOI: (B)(6) 2021 DOR: (B)(6) 2021 RIGHT SHOULDER.

  Patient problems: Joint Laxity

  MAUDE report 12215402 ↗
• MalfunctionJan 2, 2020Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT GLENOSPHERE THREADS WOULD NOT ENGAGE INTO THE METAGLENE. WASTE 3 GLENOSPHERE UNTIL THE METAGLENE WAS REVISED. THREADS APPEARED TO BE DAMAGED. SURGEON SUGGESTED THAT PERHAPS THE THREADS IN THE METAGLENE WERE NOT SPEC. 30 MINUTES OF SURGICAL DELAY.

  Patient problems: Not Applicable

  MAUDE report 9538893 ↗