DELTA XTEND 130742203Recalls & reported problems

Summary

The FDA's MAUDE database contains 104 adverse event reports that list this exact device (DI 10603295027539), received between Nov 9, 2017 and Sep 16, 2026 — classified as 99 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (27 reports).

10 other recalls cover devices cleared under the same FDA submission (K062250, K081620, 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 104 reports, in the reporter's own words as published by the FDA.

• InjurySep 16, 2026Device Dislodged or Dislocated

  It was reported that patient has had two or three shoulder dislocations. Dr. removed the Delta Xtend Standard PE Cup D42 +3mm and implanted a new cup along with performing some soft tissue work.DOI- (b)(6) 2026.DOR- (b)(6) 2026.Affected side- Right Shoulder.

  Patient problems: Joint Dislocation

  MAUDE report 50790916 ↗
• 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) 2014.DOE: (b)(6) 2026.

  Patient problems: Pain

  MAUDE report 50787573 ↗
• InjurySep 14, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a polyethylene cup was associated with a washout procedure performed to clear hematoma and potential infection, during which the polyethylene cup was exchanged. Swabs and tissue samples were taken. The reported patient impact included hematoma, infection, wound secretion, and a corrective invasive procedure in which the device was replaced. The implanted product was removed and discarded.

  Patient problems: Fluid Discharge; Hematoma; Unspecified Infection

  MAUDE report 50756623 ↗
• 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 25059194 ↗
• InjuryMar 10, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO IMPINGEMENT. DOI: (B)(6) 2022. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Joint Laxity

  MAUDE report 24560251 ↗
• InjuryMar 10, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A DELTA REVERSE CONSTRUCT BACK IN 2020. UNFORTUNATELY OVER TIME, NOTCHING OCCURRED IN THE SCAPULA. PATIENT WAS REVISED TODAY TO A LATERALIZED GLENOSPHERE AND THICKER POLY TO AVOID NOTCHING IN THE FUTURE. CEMENT MANUFACTURER WAS DEPUY SYNTHES. NON CEMENTED. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Bone Notching

  MAUDE report 24557840 ↗
• InjuryFeb 13, 2026No Apparent Adverse Event

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO I&D WASH OUT TO PREVENT INFECTION. DOI: (B)(6) 2025. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Insufficient Information

  MAUDE report 24333587 ↗
• InjuryFeb 10, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO INFECTION. SURGEON REMOVED ALL COMPONENTS AND INSERTED ANTIBIOTIC SPACER. DOI: (B)(6) 2025, DOR: (B)(6) 2026, AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Unspecified Infection

  MAUDE report 24307555 ↗
• InjuryDec 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT WAS REVISED DUE TO PAINFUL RIGHT SHOULDER. IT WAS NOTED THE GLENOSPHERE APPEARED TO BE TILTED FROM METAGLENE. THE IMPLANTS WERE REMOVED AND REPLACED. IT WAS NOTED THERE WAS A POSSIBLE INFECTION IN THE SHOULDER AND A POSSIBLE BREAK ON THE POST AT THE BOTTOM OF GLENOSPHERE AND PIECE IN THE METAGLENE POST. DOI: (B)(6) 2019. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 23935500 ↗
• InjuryDec 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INSTABILITY. DOI: (B)(6) 2022. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Joint Laxity

  MAUDE report 23790809 ↗
• InjurySep 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED STATES THAT THERE WERE COMMENTS OF MYOSITIS OSSIFICATIONS WITHIN THE ROTATOR CUFF WHICH WERE REMOVED DURING THE CASE. IT WAS UNKNOWN IF THESE CONTRIBUTED. THE SURGEON STATED THAT THERE WAS EVIDENCE OF NOTCHING ON THE CT SCANS.

  Patient problems: Bone Notching; Extraskeletal ossification; Pain

  MAUDE report 23050283 ↗
• InjuryAug 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTS WERE REMOVED DUE TO INSTABILITY. THE PATIENT HAD REPORTED NO INSTABILITY DURING THE FIRST FEW YEARS AND WAS SATISFIED WITH THE RESULTS UNTIL EXPERIENCING ISSUES OVER THE PAST 6 MONTHS. TO ACHIEVE APPROPRIATE STABILITY, THE SURGEON UPSIZED THE GLENOSPHERE AND HUMERAL CUP. THERE WERE NO PATIENT CONSEQUENCES AND NO SURGICAL DELAY OCCURRED. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Joint Laxity

  MAUDE report 22770851 ↗
• InjuryAug 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. ALL PARTS WERE EXPLANTED. AFTER WASH OUT, NEW PARTS WERE IMPLANTED. NO SURGICAL DELAY. NO PATIENT CONSEQUENCE. DOI: (B)(6) 2023. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Unspecified Infection

  MAUDE report 22748702 ↗
• InjuryJun 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S SHOULDER BECAME INFECTED AND HARDWARE NEEDED TO BE REMOVED. DOI: (B)(6) 2022 DOR: (B)(6) 2025. AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Unspecified Infection

  MAUDE report 22160881 ↗
• InjuryMay 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO INSTABILITY. SURGICAL DELAY WAS UNKNOWN. DOI: (B)(6) 2022, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Joint Laxity

  MAUDE report 22015165 ↗
• InjuryMay 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THAYER SCHOOL OF ENGINEERING AT DARTMOUTH FIRST REPORT OF RETRIEVALS FOR STATEMENT OF WORK 10 FOR Q1 OF 2025. DARTMOUTH IS THE RESEARCH LOCATION, AND NOT THE FACILITY OF PLACEMENT. A DEPUY SYNTHES IMPLANT WAS REVISED AND REVIEWED FOR ANALYSIS REASON FOR REVISION: REVISION DUE TO INFECTION AND GLENOID LOOSENING.AT REMOVAL THE HUMERAL CUP SHOWED MINOR YELLOWING.

  Patient problems: Unspecified Infection

  MAUDE report 21979540 ↗
• InjuryApr 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S CUP WAS REVISED. THE PATIENT HAD FALLEN THE CUP WAS CHANGED OUT FOR STABILITY. DOI: (B)(6) 2016. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Fall; Joint Laxity

  MAUDE report 21873803 ↗
• InjuryApr 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED FOR INFECTION. THERE WAS NO IMPLANT FAILURE, NO BROKEN IMPLANTS OR INSTRUMENTS. THE SURGEON SWAPPED THE GLENOSPHRE, POLY, AND COLLET ALL FOR SAME SIZES. THERE WAS NO DELAY AND NO COMPLAINT FROM THE SURGEON. DOI: (B)(6) 2024. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Unspecified Infection

  MAUDE report 21773830 ↗
• InjuryMar 28, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED DUE TO DISLOCATION OF SHOULDER. HUMERAL POLY CUP REMOVED AND METAL SPACER AND NEW POLY ADDED TO STABILIZE. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2023. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Joint Dislocation; Joint Laxity

  MAUDE report 21719678 ↗
• MalfunctionFeb 4, 2025Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE POLY WAS IMPLANTED AFTER TRIALING. SURGEON USED A FREER TO TEST THE SIDES TO CONFIRM THE POLY WAS SEATED. WHILE DOING SO, THE POLY POPPED UP. HE RE-IMPACTED THE POLY AND PERFORMED THIS AGAIN WITH THE SAME RESULT. HE ASKED THAT A NEW POLY BE OPENED AND THIS ONE BE SENT BACK. AFFECTED SIDE: LEFT HIP.

  Patient problems: Insufficient Information

  MAUDE report 21304002 ↗
• InjuryJan 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A REMOVAL OF IMPLANTS DUE TO INFECTION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. NO FURTHER INFORMATION WAS PROVIDED. ACTIVITY LEVEL - YES. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Unspecified Infection

  MAUDE report 21069281 ↗
• InjuryDec 30, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ADDITIONAL INFORMATION RECEIVED STATES THAT THERE WAS NO SURGICAL DELAY.

  Patient problems: Joint Dislocation; Pain

  MAUDE report 21043459 ↗
• InjuryDec 6, 2024Device Dislodged or Dislocated; Naturally Worn; Device Dislodged or Dislocated; Naturally Worn

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH DISLOCATING DELTA XTEND REVERSE. PATIENT SAYS IT DISLOCATES IN THE NIGHT WHILE PATIENT SLEEPS. IT IS OBVIOUSLY UNSTABLE. DOCTOR REMOVED THE SEVERELY DAMAGED POLY (RIM WEAR CONSISTENT WITH PERSISTENT INSTABILITY AND RUBBING ON THE METAL IMPLANT OR BONE WHILE DISLOCATED). METAGLENE AND GLENOSPHERE WERE STABLE. GLENOSPHERE SHOWS SIGNS OF SCRATCHING DUE TO RUBBING ON METAL PART OF HUMERAL STEM, HOWEVER DOCTOR THOUGHT THE BEST PLAN FOR THIS PATIENT WAS TO LEAVE THE GLENOSPHERE AND SIMPLY REPLACE THE POLY. THEY REPLACED POLY WITH A 9MM SPACER AND ANOTHER 48 X 3MM POLY. NO ADDITIONAL INFORMATION TO REPORT. DOI: UNKNOWN DOR: (B)(6) 2024 AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Joint Dislocation; Joint Laxity

  MAUDE report 20869821 ↗
• InjurySep 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD WASHED OUT AND COMPONENTS CHANGED DUE TO INFECTION. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: UNKNOWN SHOULDER SIDE.

  Patient problems: Unspecified Infection

  MAUDE report 20268952 ↗
• InjurySep 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISION WITH POLY SWAP DUE TO INFECTION. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Unspecified Infection

  MAUDE report 20145302 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K062250, K081620, K120174, 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
• 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-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-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-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-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.