DELTA XTEND 140760020Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10603295423645), received between Dec 17, 2018 and Mar 3, 2026 — classified as 10 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Osseointegration Problem” (4 reports).

2 other recalls cover devices cleared under the same FDA submission (K120174, K192448, K192855); they may or may not involve this specific model.

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 16, 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 3, 2026Osseointegration Problem

  IT WAS REPORTED THAT SHOULDER REVISED FOR BASEPLATE LOOSENING DUE TO INFECTION. 48MM ANTIBIOTIC SPACER IMPLANTED.

  Patient problems: Inadequate Osseointegration; Unspecified Infection

  MAUDE report 24494250 ↗
• 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 21996433 ↗
• 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. INHANCE WAS USED IN COMBINATION WITH DELTA, AFTER THE DELTA EXTEND.

  Patient problems: Insufficient Information

  MAUDE report 18884500 ↗
• InjuryOct 13, 2023Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE LOOSE XTEND METAGLENE REVISE TO AUGMENT METAGLENE VS CTA. POLY SWAP AND NEW GLENOSPHERE. NO OTHER INFORMATION KNOWN. DOI: UNKNOWN, DOR: (B)(6) 2023, AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Inadequate Osseointegration

  MAUDE report 17931019 ↗
• InjuryJan 27, 2023Osseointegration Problem; Osseointegration Problem

  REVISION COMPLETED DUE TO INFECTION AND LOOSENING OF THE METAGLENE AT THE BONE TO IMPLANT INTERFACE. ALL IMPLANTS WERE REMOVED AND PLACEMENT OF SPACER WAS PERFORMED. DOI: (B)(6) 2019. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Inadequate Osseointegration; Unspecified Infection

  MAUDE report 16254909 ↗
• InjuryMar 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO INFECTION. NO SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Unspecified Infection

  MAUDE report 13720100 ↗
• InjuryNov 16, 2021Osseointegration Problem; Osseointegration Problem

  PATIENT WAS REVISED DUE TO LOOSENING OF ALL COMPONENTS AT THE BONE TO IMPLANT INTERFACE. DOI: (B)(6) 2019 DOR: (B)(6) 2021 RIGHT SHOULDER.

  Patient problems: Inadequate Osseointegration

  MAUDE report 12820598 ↗
• InjuryJul 6, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INSTABILITY. DOI: (B)(6) 2018, DOR: (B)(6) 2020, RIGHT SHOULDER.

  Patient problems: No Code Available

  MAUDE report 10236735 ↗
• InjuryMar 23, 2020Loss of Osseointegration; Loss of Osseointegration

  THE PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE METAGLENE AT THE BONE TO IMPLANT INTERFACE DUE TO FALL. DOI: (B)(6) 2019; DOR: (B)(6) 2020; RIGHT SHOULDER.

  Patient problems: Fall; Inadequate Osseointegration; No Code Available

  MAUDE report 9868447 ↗
• InjuryFeb 27, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO SHOULDER INSTABILITY. IMPLANT WAS CHANGED TO A CTA REVERSE SHOULDER. NO LOOSENING REPORTED. ORIGINAL IMPLANT DATE UNKNOWN. DOI: UNKNOWN. DOR: (B)(6) 2020. AFFECTED SIDE: UNKNOWN

  Patient problems: No Code Available

  MAUDE report 9763873 ↗
• 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 9538904 ↗
• InjuryDec 17, 2018Loss of Osseointegration; Loss of Osseointegration

  PATIENT WAS REVISED TO ADDRESS PAIN AND LOOSENING OF THE METAGLENE, SCREWS AND GLENOSPHERE AT THE BONE TO IMPLANT INTERFACE. THE METAGLENE, SCREWS AND GLENOSPHERE WERE KNOCKED OFF THE GLENOID. PATIENT HAS MANY COMORBIDITIES AND WAS PULLING HIMSELF IN AND OUT OF HIS CAR DUE TO HAVING A BKA. TOOK OUT THE CUP, METAGLENE,SCREWS AND GLENOSPHERE AND PUT IN A 52/26 CTA HEAD. DOI: (B)(6) 2018. DOR: (B)(6) 2018; RIGHT SHOULDER.

  Patient problems: Inadequate Osseointegration; No Code Available; Pain

  MAUDE report 8170151 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K120174, K192448, K192855. One submission often covers many models, so check the product and lot details in each record.

• Z-0834-2018 · Aug 31, 2017 · Terminated
  DELTA XTEND" Reverse Shoulder System Modular Centered and Eccentric Epiphysis Implants intended for use in total shoulder or hemi-shoulder replacement procedures in patients with n
• Z-0833-2018 · Aug 31, 2017 · Terminated
  DELTA XTEND" Reverse Shoulder System Modular Centered and Eccentric Epiphysis Implants are intended for use in total shoulder or hemi-shoulder replacement procedures in patients wi