DELTA XTEND 130770036Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10603295027812), received between Dec 28, 2018 and May 1, 2026 — classified as 9 injuries, 1 malfunction.

The most frequently reported specific device problem is “Osseointegration Problem” (2 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 16, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryMay 1, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REMOVAL OF ALL GLENOID IMPLANTS AND IMPLANTATION OF A CTA HEAD ONTO THE STEM DUE TO INFECTION. DOI: UNKNOWN. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Unspecified Infection

  MAUDE report 25059199 ↗
• 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 23542618 ↗
• 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 23532281 ↗
• InjuryOct 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL CASE IN REGARDS TO (B)(4) TO CAPTURE THE PREVIOUS PARTIAL REVISION. 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.

  Patient problems: Unspecified Infection

  MAUDE report 23372465 ↗
• InjuryJun 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS INFECTED. THE SURGEON REMOVED THE POLY, GLENOSPHERE, METAGLENE AND SCREWS. THE SURGEON REMOVED 3 LOCKING SCREWS; HOWEVER, THE PRODUCT NUMBERS ARE NOT AVAILABLE. ALSO, THE POLY WAS WORN ON THE ANTERIOR FACE SO THE PRODUCT NUMBER OR LOT NUMBER WERE UNREADABLE. THE SURGEON CONVERTED IT TO A CTA HEMI. DOI: UNKNOWN, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT SHOULDER,

  Patient problems: Unspecified Infection

  MAUDE report 22289781 ↗
• InjuryJun 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REVERSE SHOULDER PROSTHESIS WAS IMPLANTED IN OUR HOSPITAL FOUR YEARS AGO. ITS FUNCTION IS EXCELLENT. A FIRM, ELASTIC BULGE HAS FORMED ANTERIORLY IN THE AREA OF THE DELTOIDEOPECTORAL APPROACH. RADIOLOGICAL EXAMINATION ON (B)(6) 2024, REVEALED A DISLOCATION OF THE GLENOSPHERE RELATIVE TO THE METAGLENE. THERE IS AN INDICATION FOR REPLACEMENT OF THE GLENOSPHERE AND, IF NECESSARY, ALSO THE METAGLENE IN CONJUNCTION WITH AN INLAY REPLACEMENT. THE REVISION SURGERY TOOK PLACE ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED WITH NO ISSUES NOTED.

  Patient problems: Foreign Body Reaction; Unspecified Tissue Injury

  MAUDE report 22136047 ↗
• InjuryDec 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS COMPLAINING OF PAIN FROM ORIGINAL SURGERY. SURGEON TOOK A CT TO DETERMINE IF THERE WAS ANY NOTCHING AND DIDN¿T NOTICE ANYTHING UNUSUAL EXCEPT THAT THE SUPERIOR SCREW MAY BE TOO LONG. THE SURGEON TOOK CULTURES DURING THE CASE TO RULE OUT INFECTION. THERE WAS NO NOTICEABLE POLY WEAR AND NO NOTICEABLE SCAPULAR NOTCHING WHEN RETRIEVING THE IMPLANTS. THE SURGEON DECIDED TO SWITCH OUT THE SUPERIOR SCREW FOR A SHORTER 18 NON LOCKER AND REPLACED GLENOSPHERE WITH A MORE LATERALIZED ECCENTRIC OPTION. SURGEON SAID THAT HE HAD A GOOD RANGE OF MOTION WITH THE NEW COMBINATION. DOI: (B)(6) 2021. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Pain

  MAUDE report 15950355 ↗
• MalfunctionJun 17, 2021Fracture; Fracture

  ONE NON LOCKING SCREW FOR METAGLENE DELTA XTEND PROTHESE IS BROKEN WHEN SCREWING IN TO THE METAGLENE (FRACTURE UNDER SCREW HEAD).

  Patient problems: Insufficient Information

  MAUDE report 12017232 ↗
• 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 9763869 ↗
• 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 8204356 ↗

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-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-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-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-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-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-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.