DELTA XTEND 130770042Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10603295027829), received between Dec 28, 2018 and Apr 30, 2026 — classified as 8 injuries, 1 malfunction.

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

10 other recalls cover devices cleared under the same FDA submission (K062250, K120174, 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 18, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryApr 30, 2026Fracture

  IT WAS REPORTED THAT THE METAGLEEN FAILED AND BROKE THREE SCREWS. THIS WAS THE SECOND REVISION FOR THIS PATIENT WHO ORIGINALLY HAD BONE GRAFT DONE. THE DOCTOR CONVERTED THIS TO A HEMI. AFFECTED SIDE- RIGHT SHOULDER.

  Patient problems: Insufficient Information

  MAUDE report 25042961 ↗
• InjuryApr 30, 2026Fracture

  IT WAS REPORTED THAT THE METAGLEEN FAILED AND BROKE THREE SCREWS. THIS WAS THE SECOND REVISION FOR THIS PATIENT WHO ORIGINALLY HAD BONE GRAFT DONE. THE DOCTOR CONVERTED THIS TO A HEMI. AFFECTED SIDE- RIGHT SHOULDER.

  Patient problems: Insufficient Information

  MAUDE report 25042823 ↗
• InjuryNov 13, 2025Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE DELTA EXTEND BASE PLATE CAME LOOSE. THE ORIGINAL SURGERY WAS DONE WITH GRAFT BEHIND THE GLENOSPHERE. THE DOCTOR NOTED THAT THE BONE DIDN'T INTERFERE THAT WELL AND WAS LIKELY THE REASON FOR FAILURE. THE DOCTOR REMOVED THE BASE PLATE AND POLY; IT WAS REPLACED WITH A CTA HEMI HEAD. DOI: UNKNOWN. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Inadequate Osseointegration

  MAUDE report 23542596 ↗
• InjuryNov 12, 2025Osseointegration Problem; Osseointegration Problem

  PATIENT WAS REVISED DUE TO BASEPLATE CAME LOOSE. DOCTOR DID THE ORIGINAL CASE WITH BONE GRAFT BEHIND THE METAGLEEN AND IF FAILED. HE REVISED IT TO A CTA HEMI AND REMOVED THE BASE PLATE AND POLY. DOI: (B)(6) 2022, DOR: UNKNOWN, AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Inadequate Osseointegration

  MAUDE report 23532172 ↗
• InjuryAug 3, 2023Osseointegration Problem; Osseointegration Problem

  PATIENT WAS REVISED DUE TO LOOSENING OF METAGLENE AND GLENOSPHERE. SCREWS WERE ALSO BROKEN. PATIENT ALSO EXPERIENCED PAIN AND POSSIBLE INFECTION. THERE WAS NO SURGICAL DELAY. DOI- (B)(6) 2012. DOR- (B)(6) 2023. AFFECTED SIDE- RIGHT SHOULDER.

  Patient problems: Inadequate Osseointegration; Pain; Unspecified Infection

  MAUDE report 17450439 ↗
• MalfunctionOct 19, 2021Fracture; Fracture

  PROCEDURE - LEFT REVERSE SHOULDER REPLACEMENT. . WHEN SCREWING IN THE SIZE 42MM NON LOCKING SCREW INTO THE METAGLENE THE TOP/HEAD OF THE SCREW SHEARED OFF WITH THE FIRST 2 THREADS ATTACHED. REMAINING PART OF SCREW LEFT IN THE PATIENT. NO DELAY TO THE PROCEDURE. SURGEON CONTINUED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12662643 ↗
• 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 10236740 ↗
• InjuryNov 26, 2019Loss of Osseointegration; Osseointegration Problem; Loss of Osseointegration; Osseointegration Problem

  THE PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE METAGLENE AT THE BONE TO IMPLANT INTERFACE. A FAILED GLENOID REVISION RECONSTRUCTION CONVERTED TO DELTA CTA. DOI: (B)(6) 2019; DOR: (B)(6) 2019; RIGHT SHOULDER.

  Patient problems: Inadequate Osseointegration; No Code Available

  MAUDE report 9377573 ↗
• InjuryDec 28, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CUSTOMER REPORTS: UNCOUPLING OF THE GLENOSPHERE FROM THE GENOID BASE (METAGLENE) OF THE RIGHT SHOULDER PROSTHESIS. METALLOSIS WAS FOUND IN THE ARTICULATION DURING THE REVISION SURGERY. SCREW BREAKAGE OF THE GLENOSPHERE OCCURED DURING THE EXTRACTION OF THE IMPLANT.

  Patient problems: Loss of Range of Motion; No Code Available; Pain; Tissue Damage

  MAUDE report 8204364 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K062250, K120174, K192855. One submission often covers many models, so check the product and lot details in each record.

• 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
• 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-0535-2009 · Jul 10, 2008 · Terminated
  Depuy DELTA Xtend, Standard Humeral PE Cup, Dia 38/+6R RET, sterile, Depuy France; REF 130738106. The device is used as a shoulder implant.
• Z-0539-2009 · Jul 10, 2008 · Terminated
  Depuy DELTA Xtend, Standard Humeral PE Cup, Dia 42+6R RET, sterile, Depuy France; REF 130742106. The device is used as a shoulder implant.
• Z-0536-2009 · Jul 10, 2008 · Terminated
  Depuy DELTA Xtend, Standard Humeral PE Cup, Dia 42/+3 STD, sterile, Depuy France; REF 130742203. The device is used as a shoulder implant.
• Z-0532-2009 · Jul 10, 2008 · Terminated
  Depuy DELTA Xtend, Standard humeral PE Cup Dia 38/+3 STD, sterile, Depuy France; REF 130738203. The device is used as a shoulder implant.
• Z-0538-2009 · Jul 10, 2008 · Terminated
  Depuy DELTA Xtend, Standard Humeral PE Cup, Dia 42/+9 STD, sterile, Depuy France; REF 130742209. The device is used as a shoulder implant.
• Z-0534-2009 · Jul 10, 2008 · Terminated
  Depuy DELTA Xtend, Standard Humeral PE Cup, Dia 38/+9 STD, sterile, Depuy France; REF 130738209. The device is used as a shoulder implant.
• Z-0533-2009 · Jul 10, 2008 · Terminated
  Depuy DELTA Xtend, Standard Humerus PE Cup, Dia 38/+6 STD, sterile, Depuy France; REF 130738206. The device is used as a shoulder implant.
• Z-0537-2009 · Jul 10, 2008 · Terminated
  Depuy DELTA Xtend, Standard Humeral PE Cup, Dia 42/+6 STD, sterile, Depuy France; REF 130742206. The device is used as a shoulder implant.