DELTA XTEND 130710000Recalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 10603295027126), received between Sep 12, 2017 and Sep 16, 2026 — classified as 30 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Loss of Osseointegration” (6 reports).

2 other recalls cover devices cleared under the same FDA submission (K071379, 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 32 reports, in the reporter's own words as published by the FDA.

• InjurySep 16, 2026Adverse Event Without Identified Device or Use Problem

  It was reported revision surgery of a Right-side Delta XTend reverse shoulder occurred due to pain. DOI: (b)(6), 2014DOE: (b)(6), 2026

  Patient problems: Pain

  MAUDE report 50787315 ↗
• InjuryMay 13, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PERIPROSTHETIC FRACTURE. DOI: (B)(6) 2024, DOR: (B)(6) 2026, AFFECTED SIDE-LEFT SHOULDER.

  Patient problems: Bone Fracture(s)

  MAUDE report 25159678 ↗
• InjuryOct 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IMPLANT SIDE: RIGHT SHOULDER. INITIAL IMPLANT: DELTA XTEND. CASE 1: INITIAL IMPLANTATION. PROCEDURE: INSERTION OF DELTA XTEND. INDICATION: CUFF TEAR ARTHROPATHY. CASE 2: PARTIAL REVISION. PROCEDURE: REMOVAL OF ALL COMPONENTS EXCEPT THE STEM. RETAINED COMPONENT: STEM. NEW COMPONENTS INSERTED: EPI BODY, CTA HEAD. INDICATION: SUSPECTED INFECTION. STEM WAS WELL-FIXED AND COULD NOT BE REMOVED. CTA HEAD PLACED ONTO RETAINED STEM. PURULENT FLUID OBSERVED IN BONE AND ON IMPLANTS. SWABS TAKEN FOR MICROBIOLOGICAL TESTING. PATIENT COMMENCED ON HIGH-DOSE ANTIBIOTICS. CASE 3: COMPLETE REMOVAL AND SPACER INSERTION. PROCEDURE: REMOVAL OF ALL COMPONENTS. INSERTION OF ANTIBIOTIC SPACER. ITEMS REMOVED: CTA HEAD, EPI BODY (RIGHT), STEM. INDICATION: PERSISTENT PAIN. POSITIVE TEST RESULTS FOR STAPHYLOCOCCUS AND PROPIONIBACTERIUM ACNES. THE CEMENT ANTIBIOTIC SPACER IS STILL IN AS OF (B)(6) 2025. THE JOINT IN NON-FUNCTIONAL UNTIL THE SPACER COMES OUT AND A NEW PROSTHESIS GOES IN.

  Patient problems: Unspecified Infection

  MAUDE report 23369952 ↗
• InjuryJul 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT REMOVAL OF DELTA XTEND DUE TO INFECTION. DOI: UNKNOWN 2015. DOR: (B)(6) 2025. AFFECTED SIDE: UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 22462401 ↗
• InjuryJan 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT SHOULDER WAS REVISED DUE TO FRACTURE/DISLOCATION. DOI: (B)(6) 2017, DOR: (B)(6) 2024, AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Bone Fracture(s)

  MAUDE report 21085645 ↗
• 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 21081398 ↗
• 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 20848003 ↗
• InjuryMay 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAS CATOSTROPHOC FAILURE. PUT A NEW GLENOSPHERE IN AND A SPACER. THIS IS A PATIENT WHO HAS BEEN REVISED MULTIPLE TIMES. DOI: ON (B)(6) 2015, DOR: ON (B)(6) 2024, AFFECTED SIDE : RIGHT SHOULDER .

  Patient problems: Pain; Unspecified Infection

  MAUDE report 19304490 ↗
• InjuryAug 29, 2023Osseointegration Problem; Osseointegration Problem

  PATIENT WAS REVISED DUE TO LOOSENING OF THE STEM. THE SURGEON REMOVED AND REPLACED HUMERAL STEM AND RETAINED ORIGINAL GLENOID COMPONENTS. DOI: (B)(6) 2020 DOR: (B)(6) 2023 AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Inadequate Osseointegration

  MAUDE report 17642528 ↗
• InjuryAug 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A RIGHT DELTA XTEND REVERSE SHOULDER REPLACEMENT APPROXIMATELY 6 MONTHS AGO. PATIENT REPRESENTED TO SURGEON COMPLAINING OF PAIN, UNEXPLAINED ORIGIN. PROCEDURE; FIRST STAGE REVISION OF ALL COMPONENTS AND INSERTION OF GLOBAL AP HEMIARTHROPLASTY CEMENT 'SPACER'. UPON OPENING THE SHOULDER AND EXAMINING THE JOINT THE SURGEON SUSPECTED A LOW GRADE INFECTION WAS PRESENT. MULTIPLE SPECIMENS AND SWABS WERE TAKEN. DOI: UNKNOWN. DOE: (B)(6) 2023. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 17480057 ↗
• InjurySep 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. ALL PARTS AND PIECES WERE REMOVED TO TREAT THE INFECTION. DOI: (B)(6) 2016. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Unspecified Infection

  MAUDE report 15484820 ↗
• 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 13720159 ↗
• InjuryNov 10, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RECURRENT DISLOCATION, METALOSIS AND INFECTION AS A RESULT. REVISED TO MONOBLOCK STEM WITH CTA HEAD.

  Patient problems: Foreign Body Reaction; Unspecified Infection

  MAUDE report 12789179 ↗
• InjuryAug 13, 2021Migration; Migration

  REVISION OF REVERSE SHOULDER FOR SUSPECTED INFECTION, EXPLANTS SENT OFF FOR CULTURE, PHOTO OF SCAN ATTACHED. SURGEON REMOVED PREVIOUS ROTATOR CUFF REPAIR ANCHOR SITTING IN HUMERAL CANAL AS THEY SUSPECT IT COULD HAVE BEEN RESPONSIBLE FOR STEM SUBSIDING INTO VARUS AND INFECTION. AS THIS WAS A REVISION PROCEDURE, THERE WAS NO EXTENSION TO THE SURGICAL TIME.

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

  MAUDE report 12318319 ↗
• InjuryMar 31, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION OF SHOULDER REPLACEMENT - REMOVAL OF ALL IMPLANTS, ANTIBIOTIC SPACER IMPLANTED. RIGHT SHOULDER.

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

  MAUDE report 11599024 ↗
• InjuryMar 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION. REMOVED ALL HARDWARE. NO SURGICAL DELAY. DOI: UNKNOWN; DOR: (B)(6) 2021; LEFT SHOULDER.

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

  MAUDE report 11521370 ↗
• InjuryNov 18, 2020Loss of Osseointegration; Loss of Osseointegration

  THE PATIENT WAS REVISED TO ADDRESS LOOSE STEM AT BONE TO IMPLANT INTERFACE. DOI: (B)(6) 2020. DOR: (B)(6) 2020; LEFT SHOULDER.

  Patient problems: Inadequate Osseointegration; No Code Available

  MAUDE report 10861852 ↗
• InjuryJun 11, 2020Loss of Osseointegration; Loss of Osseointegration

  PATIENT HAD PRIMARY REVERSE SHOULDER ARTHROPLASTY ON THE (B)(6) 2015. APPROXIMATELY THREE MONTHS AGO THE PATIENT STARTED EXPERIENCING PAIN IN THE OPERATIVE SHOULDER. HE APPROACHED THE TREATING SURGEON AND SURGEON CONFIRMED ASEPTIC LOOSENING OF THE HUMERAL COMPONENT. REVISION SURGERY PERFORMED ON (B)(6) 2020 AT (B)(6) HOSPITAL. CONFIRMED DURING SURGERY THAT HUMERAL COMPONENT WAS LOOSE AS IT COULD BE REMOVED WITHOUT THE AID OF INSTRUMENTS.

  Patient problems: Inadequate Osseointegration; No Code Available; Pain

  MAUDE report 10145416 ↗
• InjuryJun 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION SHOULDER ARTHROPLASTY: (B)(6) 2020. PRIMARY IMPLANT DATE: (B)(6) 2017. PAINFUL, INFECTED PROSTHETIC JOINT, ACCORDING TO SURGEON. ALL PROSTHESIS REMOVED. PATIENT OUTCOME: STABLE SHOULDER JOINT. NO AE REPORTED. NO DELAY IN THE SURGERY. FEMALE PATIENT. (B)(6).

  Patient problems: No Code Available; Pain; Unspecified Infection

  MAUDE report 10133850 ↗
• InjuryApr 8, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LONG-STANDING HISTORY OF PAIN AND INFECTION FOR THE PAST YEAR. TREATED CONSERVATIVELY INITIALLY (LONG COURSE OF ANTIBIOTICS), THEN WASHOUT LAST YEAR. ALL PROSTHESIS, INCLUDING 4 X SCREWS, DISCARDED. THE HUMERAL STEM WAS WELL FIXED, BUT GLENOID COMPONENTS WERE VERY LOOSE. SIGNIFICANT BONE LOSS NOTED IN GLENOID. MULTIPLE SPECIMENS WERE TAKEN. ALL PROSTHESIS REMOVED - TEMPORARY ANTIBIOTIC CEMENT SPACER IMPLANTED. PATIENT OUTCOME POST SURGERY: STABLE.

  Patient problems: No Code Available; Pain; Unspecified Infection

  MAUDE report 9934058 ↗
• InjuryMar 24, 2020Loss of Osseointegration; Loss of Osseointegration

  STEM LOOSENING.

  Patient problems: Inadequate Osseointegration; No Code Available

  MAUDE report 9871965 ↗
• InjuryDec 17, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS INSTABILITY. DOI: UNK; DOR: (B)(6) 2019; RIGHT SHOULDER.

  Patient problems: No Code Available; Not Applicable

  MAUDE report 9483273 ↗
• MalfunctionNov 25, 2019Difficult to Insert; Adverse Event Without Identified Device or Use Problem; Difficult to Insert; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT STEM AND EPIPHYSIS DO NOT MATE TOGETHER PROPERLY. IMPLANTS DEFECTIVE NEED TO BE RETURNED TO DEPUY. RIGHT SHOULDER.

  Patient problems: No Code Available; Not Applicable

  MAUDE report 9369151 ↗
• InjuryNov 13, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LEFT SHOULDER REVISION - REMOVED ALL IMPLANTS DUE TO INFECTION.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9314929 ↗
• InjurySep 27, 2019Loss of Osseointegration; Loss of Osseointegration

  THE PATIENT WAS REVISED TO ADDRESS DISLOCATION AND LOOSENING OF THE HUMERAL STEM AT THE BONE TO IMPLANT INTERFACE. DOI: (B)(6) 2017. DOR: (B)(6) 2019, RIGHT SHOULDER.

  Patient problems: Inadequate Osseointegration; Joint Dislocation; No Code Available

  MAUDE report 9131274 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K071379, 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