DELTA XTEND 1307-61-042Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10603295502609), received between Mar 13, 2020 and Apr 27, 2026 — classified as 10 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Difficult to Insert” (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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjuryApr 27, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT EXPERIENCED PAIN FROM NOTCHING. SURGEON ELECTED TO TAKE GLENOSPHERE OUT AND PUT IN ECCENTRIC LATERALIZED GLENOSPHERE. SURGEON ALSO PUT IN THICKER POLY. DOI: (B)(6) 2017. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Bone Notching; Pain

  MAUDE report 25002350 ↗
• MalfunctionFeb 18, 2026Difficult to Insert; Material Deformation

  IT WAS REPORTED THAT DURING A REVERSE SHOULDER ARTHROPLASTY ON THE RIGHT SHOULDER, WHILE THE SURGEON WAS IMPLANTING THE FIRST SIZE 42 STANDARD GLENOSPHERE, THE HEAD COULD NOT BE SEATED. WHEN THE DEVICE WAS PULLED OUT AFTER USE, IT WAS OBSERVED THAT THE THREADS WERE STRIPPED/DAMAGED. THE USER DID THIS 2 MORE TIMES WITH ANOTHER SIZE 42 STANDARD, AND THEN WITH A 42 ECCENTRIC. THE SURGERY TIME WAS EXTENDED BY ANOTHER HOUR AND A HALF DUE TO THE EVENT.

  Patient problems: Insufficient Information

  MAUDE report 24377786 ↗
• InjuryJul 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAS INSTABILITY AND WAS REVISED FROM A GLENOSPHERE AND POLY TO A MORE LATERALIZED CONSTRUCT. THERE WAS NO REPORTED IMPLANT FAILURE; ALL PIECES WERE REMOVED AND RETRIEVED. THE COLLETT WAS CHANGED. THERE WAS NO SURGICAL DELAY OR ADVERSE REACTION TO THE PATIENT. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Joint Laxity

  MAUDE report 22479909 ↗
• InjuryApr 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INFECTED POLY AND GLENOSPHERE. NO PROBLEMS, SURGERY WENT SMOOTH. DOI: (B)(6) 2025. DOR: (B)(6) 2025 AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Unspecified Infection

  MAUDE report 21880561 ↗
• InjuryApr 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED FOR INFECTION. THERE WAS NO IMPLANT FAILURE, NO BROKEN IMPLANTS OR INSTRUMENTS. THE SURGEON SWAPPED THE GLENOSPHRE, POLY, AND COLLET ALL FOR SAME SIZES. THERE WAS NO DELAY AND NO COMPLAINT FROM THE SURGEON. DOI: (B)(6) 2024. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Unspecified Infection

  MAUDE report 21772763 ↗
• InjuryNov 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED, THAT THE PATIENTS LEFT SHOULDER IS BEING REVISED, DUE TO INSTABILITY. DOI: (B)(6) 2021. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Joint Laxity

  MAUDE report 20752768 ↗
• InjuryAug 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE INFECTION. IMPLANT WAS REMOVED. DOI: (B)(6) 2023. DOR: (B)(6) 2024. AFFECTED SIDE: UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 20054410 ↗
• InjuryJun 21, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT WAS REVISED DUE TO DISLOCATION. NO DELAYS. NO OTHER INFORMATION AVAILABLE. DOI: ((B)(6), 2024 DOR: (B)(6) 2024 AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Joint Dislocation

  MAUDE report 19589605 ↗
• InjuryJun 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Unspecified Infection

  MAUDE report 19498882 ↗
• InjuryJan 31, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT HAD POLY/GLENOSPHERE SWAP FOR DISLOCATION. NO OTHER INFORMATION KNOWN. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Joint Dislocation

  MAUDE report 18613437 ↗
• InjurySep 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO INFECTION. DOI: (B)(6) 2022. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Unspecified Infection

  MAUDE report 15336303 ↗
• MalfunctionSep 22, 2021Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE GLENOSPHERES WOULDN¿T THREAD INTO METAGLENE. NO SURGICAL DELAY. DOE: (B)(6) 2021 RIGHT SHOULDER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12513949 ↗
• MalfunctionSep 22, 2021Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE GLENOSPHERES WOULDN¿T THREAD INTO METAGLENE. NO SURGICAL DELAY. DOE: (B)(6) 2021, RIGHT SHOULDER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12513927 ↗
• MalfunctionOct 22, 2020Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT NEITHER OF THE GLENOSPHERES WOULD THREAD INTO THE METAGLENE. THE THREADS APPEARED TO GET DAMAGED SOMEHOW. THE SURGEON FELT LIKE SOMETHING MAY HAVE BEEN WRONG WITH THE METAGLENE. BUT THE THIRD ONE WE TRIED FINALLY THREADED IN. A SURGICAL DELAY OF 10 MINUTES. DOE: (B)(6), 2020 LEFT SHOULDER.

  Patient problems: No Code Available

  MAUDE report 10720767 ↗
• MalfunctionMar 13, 2020Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE GLENOSPHERE WAS ATTEMPTED TO PLACE ON METAGLENE. UNABLE TO ENGAGE SCREW OR COMPLETELY SEAT GLENOSPHERE. FIRST TIME USING THIS TYPE OF GLENOSPHERE. ATTEMPTED 4 TIMES AND ENDED UP SWITCHING TO OLD GLENOSPHERE AND ENGAGED SCREW AND SEATED FIRST ATTEMPT. A 15-20 MINUTE SURGICAL DELAY. DOE: (B)(6) 2020; RIGHT SHOULDER.

  Patient problems: No Code Available

  MAUDE report 9829494 ↗