DELTA XTEND 1307-61-038Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10603295502593), received between Mar 3, 2021 and Jan 29, 2026 — classified as 11 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (5 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.

• InjuryJan 29, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A FRACTURE AND JOINT INSTABILITY, NECESSITATING A REVISION PROCEDURE IN WHICH THE ORIGINAL IMPLANTS WERE REPLACED WITH A CTA HEAD FOR INCREASED STABILITY. DOI: (B)(6) 2021. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Bone Fracture(s); Joint Laxity

  MAUDE report 24211278 ↗
• InjuryAug 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED WITH THIS WEDGE BASEPLATE DUE TO INSTABILITY AND IT MAY HAVE BEEN LOOSE. THERE WAS LOOSENING OF BASEPLATE AT NON BONE TO IMPLANT INTERFACE. DEPUY CEMENT WAS USED. SURGEON TOOK OUT BASEPLATE OUT IN A STD BASEPLATE WITH CENTRAL SCREW, PUT IN NEW GLENOSPHERE, UPSIZED POLY. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: UNKNOWN SHOULDER.

  Patient problems: Joint Laxity

  MAUDE report 22806491 ↗
• InjuryMay 29, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO DISLOCATION. THERE WAS NO IMPLANT FAILURE; SIZED GLENO UP FOR LATERALIZATION. THERE WAS NO LOOSENING, NO SURGEON COMPLAINT, NO BROKEN IMPLANT OR INSTRUMENT, NO DELAY. NO PIECES WERE LEFT BEHIND. AFFECTED SIDE: UNKNOWN SHOULDER.

  Patient problems: Joint Dislocation

  MAUDE report 22103751 ↗
• InjuryMar 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT FELL AND NEEDED MORE LATERALIZED IMPLANTS FOR STABILITY. DOI: UNKNOWN. DOR: UNKNOWN. AFFECTED SIDE: UNKNOWN SHOULDER SIDE.

  Patient problems: Fall; Joint Laxity

  MAUDE report 21678417 ↗
• InjuryDec 4, 2024Adverse 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. DOI: (B)(6) 2022. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Unspecified Infection

  MAUDE report 20848632 ↗
• InjuryApr 2, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

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

  Patient problems: Joint Dislocation

  MAUDE report 19019761 ↗
• MalfunctionNov 29, 2023Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE THREADS WOULD NOT ENGAGE. THERE WAS A SURGICAL DELAY OF UNKNOWN TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18228554 ↗
• InjuryMay 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT IS INFECTED. ALL IMPLANTS REMOVED. NO SURGICAL DELAY REPORTED. NO REPORTED LOOSENING. DOI: (B)(6) 2022; DOR: (B)(6) 2022; AFFECTED SIDE: RIGHT.

  Patient problems: Unspecified Infection

  MAUDE report 14345858 ↗
• InjuryAug 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS PAIN WITH ROM. SURGEON DETERMINED THERE WAS SCAPULAR NOTCHING AND IMPINGEMENT, SUGGESTING THE PATIENT NEEDED MORE LATERALIZATION. HE REVISED THE GLENOSPHERE TO A PLUS 6 AND CHANGED OUT THE HUMERAL POLY INSERT. THERE WAS NO LOOSENING OF THE COMPONENTS AND NO DEFICIENCY NOTED WITH THE IMPLANTS. THERE WAS NO DELAY IN THE PROCEDURE. DOI: (B)(6) 2020, DOR: (B)(6) 2021, RIGHT SHOULDER.

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

  MAUDE report 12370087 ↗
• InjuryJul 29, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT WAS REVISED TO ADDRESS DISLOCATION. NO LOOSENING REPORTED. NO SURGICAL DELAY. DOI: (B)(6) 2021. DOR: (B)(6) 2021; RIGHT SHOULDER.

  Patient problems: Joint Dislocation

  MAUDE report 12245283 ↗
• InjuryMay 26, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WAS COMPLAINING OF PAIN AFTER PICKING UP A CASE OF SODA. WITH CONSERVATIVE TREATMENT, THE PAIN DID NOT SUBSIDE. DURING THE REVISION EXPLORATION, IT WAS FOUND THAT THE GLENOSPHERE WAS LOOSE AND IT WAS REMOVED. THE METAGLENE WAS CHECKED AND ALL COMPONENTS WERE STABLE. A 38+2 GLENOSPHERE WAS IMPLANTED AND A 38+9 CUP WAS TRIALED. THE SURGEON ADDED A +9MM SPACER AND A 38+3 CUP. THE PATIENT WAS STABLE WITH THESE COMPONENTS AND THEY WERE IMPLANTED. DOI: (B)(6) 2020. DOR: (B)(6) 2021. RIGHT SHOULDER.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Pain

  MAUDE report 11891568 ↗
• InjuryMar 3, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT DISLOCATED THE SHOULDER AFTER REVERSE TOTAL SHOULDER SURGERY. PATIENT WAS REVISED TO A LARGER GLENOSPHERE. NO DELAY IN SURGERY. DOI: (B)(6) 2021, DOR: (B)(6) 2021, RIGHT SHOULDER.

  Patient problems: Joint Dislocation

  MAUDE report 11406527 ↗