DELTA XTEND 1307-62-038Recalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 10603295502432), received between Feb 10, 2020 and Sep 28, 2026 — classified as 21 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Difficult to Insert” (9 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 25 most recent of 31 reports, in the reporter's own words as published by the FDA.

• InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unspecified Infection

  MAUDE report 50923253 ↗
• InjurySep 24, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that patient presented with a painful right shoulder. The surgeon revised the glenosphere and poly.Affected Side: Unknown Shoulder.

  Patient problems: Pain

  MAUDE report 50881916 ↗
• InjurySep 14, 2026Device Dislodged or Dislocated

  It was reported that the patient revised due to dislocation.DOI: (b)(6) 2020.DOR: (b)(6) 2026.Affected side: Left shoulder.

  Patient problems: Joint Dislocation

  MAUDE report 50752309 ↗
• InjuryMay 27, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT REVISED DUE TO INFECTION. EVERYTHING TAKEN OUT. DOI: (B)(6) 2024, DOR: (B)(6) 2026, AFFECTED SIDE: LEFT.

  Patient problems: Unspecified Infection

  MAUDE report 25303204 ↗
• InjuryMay 9, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED DUE TO LOOSENING OF THE HUMERAL STEM AT THE CEMENT TO IMPLANT INTERFACE. CEMENT MANUFACTURER WAS UNKNOWN. IT WAS ALSO REPORTED THAT THE PATIENT BROKE HER HUMERUS MID SHAFT, JUST DISTAL TO THE HUMERAL STEM. SURGEON REMOVED IMPLANTS TO REVISE SHOULDER USING ANOTHER VENDOR AFTER FIXING FRACTURE. NO KNOWN INFECTION PRESENT. NO DELAY IN SURGERY. STEM WAS A LITTLE LOOSE. GLENOSPHERE WAS NOT ENGAGED VIA THE CENTRAL SCREW TO METAGLENE. METAGLENE WAS NOT LOOSE, BUT REMOVED ANYWAYS. DOI: (B)(6) 2020, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Insufficient Information

  MAUDE report 21996435 ↗
• InjuryFeb 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD AN UNSTABLE SHOULDER. THE SURGEON UP SIZED CUP COMPONENTS. DOI: UNKNOWN, DOR: (B)(6) 2025. AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Joint Laxity

  MAUDE report 21458499 ↗
• InjuryJan 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD INFECTED SHOULDER. ALL IMPLANTS REMOVED AND ANTIBIOTIC SPACER PLACED. NO DELAYS IN SURGERY. DOI: (B)(6) 2023. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Unspecified Infection

  MAUDE report 21080740 ↗
• InjuryNov 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED, THAT PATIENT HAD REVISED FOR INSTABILITY. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Joint Laxity

  MAUDE report 20748014 ↗
• MalfunctionMar 13, 2024Difficult to Insert; Off-Label Use; Difficult to Insert; Off-Label Use

  IT WAS REPORTED THAT THE GLENOSPHERE SCREW WOULD NOT LOCK INTO THE METAGLENE COLLET. EVERYTHING WAS IMPLANTED AND USED ACCORDING THE THE SURGICAL TECHNIQUE, BUT WHEN THE SURGEON WENT TO TIGHTENT THE SCREW INTO THE METAGLENE IT ACTED AS IF IT WAS STRIPPED. A GOOD BITE WAS NOT ATTAINABLE AND THE SCREW WOULD JUST KEEP SPINNING AND NOT ENGAGE INTO THE COLLET. ANY EXCESS BONE WAS REMOVED AROUND THE METAGLENE, SO THE SURGEON DID NOT SEE ANY INTERFERENCE WITH THE HEAD. THE GLENOSPHERE HAD GOOD FIXATION VIA THE MORSE TAPER ONTO THE METAGLENE, SO THE SURGEON LEFT IT AS THAT WITHOUT TIGHTENING THE SCREW.

  Patient problems: Insufficient Information

  MAUDE report 18892945 ↗
• MalfunctionMar 12, 2024Difficult to Insert; Difficult to Insert

  ADDITIONAL INFORMATION WAS RECEIVED. PATIENT CONSEQUENCES EXTENDED, THE SURGERY TIME. BOTH GLENOSPHERE AND METAGLENE WERE ATTEMPTED TO BE USED IN SAME CASE AND IN BOTH METAGLENE. ENHANCE WAS USED IN COMBINATION WITH DELTA, AFTER THE DELTA EXTEND.

  Patient problems: Insufficient Information

  MAUDE report 18884493 ↗
• InjuryOct 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD A REVISED REVERSE SHOULDER FOR PAIN. NO SURGICAL DELAY. DOI: UNKNOWN, DOR: (B)(6) 2023, AFFECTED SIDE: UNKNOWN.

  Patient problems: Pain

  MAUDE report 17873421 ↗
• MalfunctionFeb 21, 2023Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE GLENOSPHERE WOULD NOT THREAD INTO THE METAGLENE AND SURGEON FELT SOMETHING WRONG WITH IMPLANT. SURGICAL DELAY IS UNKNOWN. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16409534 ↗
• InjuryDec 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RE REVISION OF A RIGHT DELTA XTEND DUE TO INSTABILITY. ORIGINAL PRIMARY SURGERY DONE ON THE (B)(6) 2022 AND THEN A 1ST REVISION OF THIS PATIENT WAS DONE ON THE (B)(6) 2022. PATIENT WAS STILL EXPERIENCING INSTABILITY, COMPONENTS CHANGED TO PROVIDE ADDITIONAL STABILITY. DOI: (B)(6) 2022. DOR (1ST): (B)(6) 2022. DOR (2ND): (B)(6) 2022.

  Patient problems: Joint Laxity

  MAUDE report 16013721 ↗
• InjuryOct 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. DOI: UNKNOWN. DOR: (B)(6) 2022. AFFECTED SIDE: UNKNOWN SHOULDER.

  Patient problems: Pain

  MAUDE report 15615703 ↗
• InjurySep 30, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT REVISED FOR SUSPECTED INFECTION. NO INFECTION IDENTIFIED. GLENOSPHERE AND POLY WERE EXCHANGED. ALL COMPLIMENTS WERE WELL FIXED, NO LOOSENING. NO SURGICAL DELAY. NOTHING FURTHER TO REPORT. DOI: UNKNOWN; DOR: (B)(6) 2022; AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Unspecified Infection

  MAUDE report 15510530 ↗
• InjuryJul 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE HEAD AND LINER WERE EXCHANGED FOR PAIN AND POOR RANGE OF MOTION. SHOULDER WAS DEBRIDED OF SCAR TISSUE AND THE POLY AND GLENOSPHERE WERE EXCHANGED FOR DIFFERENT SIZES TO ACHIEVE STABILITY. THERE WAS NO REPORTED LOOSENING. THERE WAS NO REPORTED SURGICAL DELAY. DOI: (B)(6) 2021. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Adhesion(s); Joint Laxity; Loss of Range of Motion; Pain

  MAUDE report 15122286 ↗
• InjuryJul 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO A HEMI DUE TO PAIN. NO SURGICAL DELAY. DOI: UNKNOWN, DOR: (B)(6) 2022, AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Pain

  MAUDE report 14948611 ↗
• MalfunctionJun 30, 2022Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT WHEN THE SURGEON PLACING THE GLENOSPHERE ON TO THE STANDARD BASEPLATE, THEY COULD NOT GET THE THREADS OF THE LOCKING POST TO SEAT PROPERLY AFTER. AFTER MULTIPLE ATTEMPTS ADD TRYING ALL THE TRICKS THEY KNEW, LIGHT IMPACT WAS USED. THE THREADS STILL WOULDN'T SEAT AND THEY DECIDED TO REMOVE IT AND START OVER. HOWEVER, WHEN THEY UNSCREWED TO LOCKING POST, IT WOULD NOT COME OFF, MULTIPLE THINGS WERE TRIED TO REMOVE IT SO THEY DECIDED TO CHANGE PATHS AND TRY RESEATING THE THREADS AGAIN. AFTER LIGHT IMPACTION, THE THREADS FINALLY SEATED AND SURGEON ABLE TO COMPLETE THE SURGERY. THERE WAS A SURGICAL DELAY OF 5 MINUTES.

  Patient problems: Insufficient Information

  MAUDE report 14877604 ↗
• InjuryJun 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO AN UNEXPLAINED PAIN. NO SIGN OF INFECTION. NO LOOSENING OF COMPONENTS. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2022. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Pain

  MAUDE report 14828735 ↗
• InjuryNov 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO PRESENT OF INFECTION. I&D WASHOUT WITH IMPLANT EXCHANGE WERE PERFORMED. ALL COMPONENTS HAD SOLID FIXATION. ORIGINAL IMPLANTATION WAS (B)(6) 2020. SHE HAD ANOTHER WASHOUT IN (B)(6) 2021. DOI: (B)(6) 2020. (B)(6) 2021 (GLENOSPHERE, METAGLENE AND PE CUP DOR: (B)(6) 2021. RIGHT SHOULDER.

  Patient problems: Unspecified Infection

  MAUDE report 12861781 ↗
• MalfunctionNov 17, 2021Difficult to Insert; Device Damaged Prior to Use; Difficult to Insert; Device Damaged Prior to Use

  AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12829059 ↗
• MalfunctionNov 16, 2021Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT DR. STROUD WAS DID A DELTA REVERSE SHOULDER ON THIS PATIENT AND SELECTED A ECENTRIC 38MM +2 GLENOSPHERE. ONE HE HAD THE IMPLANT POSITIONED OVER THE BASE PLATE, HE STATED HE COULD NOT GET THE THREADS TO ENGAGE. HE MADE SEVERAL ATTEMPTS AND ASKED IF I WOULD OPEN A STD 38MM + 2 GLENOSPHERE. THAT GLENOSPHERE SEATED AND THREADED INTO THE BASE PLATE. THE CASE WAS DELAYED BY 4-5MINUTES DO THE ISSUE. THE 130762038 WAS CLEANED, PUT BACK INTO BOX AND RETURNED TO MY OFFICE.

  Patient problems: Insufficient Information

  MAUDE report 12821895 ↗
• InjuryMay 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO BONE GROWTH. THE PATIENT HAD HETEROTOPIC BONE GROWTH THAT HAD GOWN OVER IMPLANTS AND CAUSED IMPINGEMENT. DOI: (B)(6) 2019, DOR: (B)(6) 2021, RIGHT SHOULDER.

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

  MAUDE report 11891684 ↗
• InjuryApr 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION ORIGINAL IMPLANT DATE IS UNKNOWN. DOI: UNKNOWN DOR: (B)(6) 2021 UNKNOWN SHOULDER SIDE.

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

  MAUDE report 11632085 ↗
• MalfunctionDec 28, 2020Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT LATERALIZED GLENOSPHERE WOULD NOT TIGHTEN DOWN ON METAGLENE. SURGEON WAS HAVING TROUBLE TIGHTENING THE PRODUCT. NO SURGICAL DELAY. DOI: (B)(6) 2020.

  Patient problems: Insufficient Information

  MAUDE report 11080201 ↗