DELTA XTEND 130738209Recalls & reported problems

Summary

The FDA's MAUDE database contains 87 adverse event reports that list this exact device (DI 10603295027386), received between Aug 18, 2017 and Sep 25, 2026 — classified as 84 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (46 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. 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 25 most recent of 87 reports, in the reporter's own words as published by the FDA.

• InjurySep 25, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Joint Laxity

  MAUDE report 50901801 ↗
• InjuryApr 17, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT WAS REVISED FOR DISLOCATION. DOI: UNKNOWN, DOR: (B)(6) 2026, AFFECTED SIDE: UNKNOWN.

  Patient problems: Joint Dislocation

  MAUDE report 24911145 ↗
• InjuryMar 31, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A REVISION SURGERY WAS COMPLETED BECAUSE OF INSTABILITY. GLENOSPHERE AND POLY CUP WERE REMOVED AND REPLACED WITH DIFFERENT SIZES. ORIGINAL DATE OF SURGERY IS UNKNOWN. AFFECTED SIDE: LEFT.

  Patient problems: Joint Laxity

  MAUDE report 24745273 ↗
• InjuryFeb 17, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO UNSTABLE SHOULDER. NO ADDITIONAL INFORMATION IS AVAILABLE. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Joint Laxity

  MAUDE report 24364768 ↗
• InjuryDec 16, 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 INFECTION, SO SURGEON DECIDED TO REMOVED IMPLANTS AND PUT IN A HEMI SHOULDER. THERE WAS NO SURGICAL DELAY.

  Patient problems: Unspecified Infection

  MAUDE report 23815139 ↗
• InjuryOct 15, 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. POLY WAS EXCHANGED FOR A PLUS 9 SPACER AND PLUS 6 RETENTIVE POLY. DOI: UNKNOWN; DOR: (B)(6) 2025; AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Joint Laxity

  MAUDE report 23303024 ↗
• InjuryAug 15, 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 THE GRADE 4 SCAPULAR NOTCHING AND THE LOOSENING OF BASE PLATE AND SCREWS. THE STANDARD BASE PLATE AND ALL 4 SCREWS WERE REMOVED. DOI: UNKNOWN, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT SIDE.

  Patient problems: Bone Notching

  MAUDE report 22819801 ↗
• InjuryAug 1, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT HAD DISLOCATED FROM BUMPING INTO A DOOR. PATIENT WAS REVISED WITH A SPACER AND POLLY TO GET IT MORE STABLE. DOI: UNKNOWN. DOR:(B)(6) 2025. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Joint Dislocation

  MAUDE report 22688182 ↗
• InjuryJul 29, 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. SURGEON PUT A THICKER INSERT IN. AFFECTED SIDE: UNKNOWN SHOULDER.

  Patient problems: Joint Laxity

  MAUDE report 22644452 ↗
• InjuryJun 25, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WAS DISLOCATED, DOCTOR DECIDED TO EXCHANGE AND MORE UP IN SIZE. AFFECTED SIDE: RIGHT SIDE.

  Patient problems: Joint Dislocation

  MAUDE report 22330669 ↗
• InjuryJun 3, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO DISLOCATION. DOI: (B)(6) 2025. DOR:(B)(6) 2025. AFFECTED AREA: UNK SHOULDER.

  Patient problems: Joint Dislocation

  MAUDE report 22133280 ↗
• InjuryMar 21, 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 INFECTION AND LOOSENING OF THE HUMERUS AT THE BONE TO IMPLANT INTERFACE. THEY COULD ONLY OBTAIN THE PART AND LOT NUMBER FROM THE HUMERAL CUP. EVERYTHING CAME OUT. THERE WAS NO DELAY IN SURGERY. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Unspecified Infection

  MAUDE report 21664274 ↗
• InjuryMar 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO SUSPECTED LEFT SHOULDER INFECTION. UNKNOWN SURGICAL DELAY. DOI: (B)(6) 2023. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Unspecified Infection

  MAUDE report 21607246 ↗
• InjuryFeb 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED TO INCREASE TENSION IN THE JOINT. SURGICAL DELAY WAS UNKNOWN. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Joint Laxity

  MAUDE report 21356284 ↗
• InjuryJan 6, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

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

  Patient problems: Joint Dislocation

  MAUDE report 21085641 ↗
• InjuryNov 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED, ON (B)(6) 2024. THE PATIENT WAS REVISED, DUE TO INSTABILITY. UNKNOWN SURGICAL DELAY. DATE OF IMPLANT UNKNOWN.

  Patient problems: Joint Laxity

  MAUDE report 20713669 ↗
• InjuryOct 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INSTABILITY. SURGICAL DELAY WAS UNKNOWN. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: UNKNOWN SHOULDER.

  Patient problems: Joint Laxity

  MAUDE report 20559491 ↗
• InjuryAug 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED FOR INSTABILITY. SURGICAL DELAY WAS UNKNOWN. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Joint Laxity

  MAUDE report 20008546 ↗
• InjuryAug 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT EVERYTHING WAS EXPLANTED AND SPACER PUT IN. DOI : (B)(6) 2022. DOR: (B)(6) 2022. AFFECTED SIDE: UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 19954041 ↗
• MalfunctionAug 8, 2024Difficult to Insert; Difficult to Insert

  IT WAS REPORTED, THAT A DELTA XTEND REVERSE CONSTRUCT WAS PLACED IN PATIENT ON (B)(6) 2024. ALL IMPLANTS HAD BEEN IMPLANTED OTHER, THAN THE STANDARD POLYETHYLENE. A 38/+9 STANDARD POLY WAS SELECTED AFTER TRIALING THE TOTAL SHOULDER. PRODUCT WAS OPENED AND IMPLANTED. IT WAS NOTED, IMMEDIATELY AT IMPACTION, THAT THE POLY WOULD INTRODUCE INTO THE MONOBLOC LONG DELTA STEM, BUT WOULD NOT SEAT FULLY. AND WOULD LIFT OUT OF THE HUMERAL STEM. IN OTHER WORDS, THE POLY WOULD ENGAGE INITIALLY, BUT THEN, MOVE OUT OF THE INTENDED POSITION IN A SUPERIOR DIRECTION. AFTER SEVERAL ATTEMPTS TO FULLY SEAT THE POLY WITH NO SUCCESS, A SECOND POLY WAS OPENED, IMPLANTED AND SEATED CORRECTLY. THE 38/9 POLY IS BEING SENT BACK TO DEPUY FOR INVESTIGATION, AS IT DID NO PERFORM PROPERLY. SURGICAL DELAY WAS UNKNOWN. DOE: (B)(6) 2024. AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Insufficient Information

  MAUDE report 19938172 ↗
• InjuryJun 6, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT DISLOCATED AND WAS NOT ABLE TO BE REDUCED IN THE CLINIC. SHE WAS BROUGHT TO THE OR TO OPEN AND REDUCE. ALL COMPONENTS WERE WELL FIXED. THE GLENOSPHERE WAS INCREASED TO A 42+2 STD AND A 42 + 6 RETENTIVE LINER WAS USED. SURGICAL DELAY WAS UNKNOWN. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: UNKNOWN SHOULDER.

  Patient problems: Joint Dislocation

  MAUDE report 19479473 ↗
• InjuryMay 13, 2024Device Dislodged or Dislocated; Naturally Worn; Device Dislodged or Dislocated; Naturally Worn

  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: (B)(6) 2015. DOR: (B)(6) 2024. AFFECTED SIDE : RIGHT SHOULDER .

  Patient problems: Joint Dislocation; Pain; Unspecified Infection

  MAUDE report 19304535 ↗
• InjuryMar 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REASON FOR PRIMARY SURGERY FRACTURED HUMERUS. REVISION OF DELTA DUE TO INFECTION SITE LEFT SHOULDER.

  Patient problems: Unspecified Infection

  MAUDE report 18895686 ↗
• InjuryNov 15, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED DUE TO DISLOCATION. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Joint Dislocation

  MAUDE report 18139708 ↗
• InjuryOct 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD A REVISED REVERSE SHOULDER FOR PAIN. NO SURGICAL DELAY. DOI: UNKNOWN, DOR: (B)(6) 2023, AFFECTED SIDE: UNKNOWN.

  Patient problems: Pain

  MAUDE report 17873425 ↗

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-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-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-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.
• 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-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-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.