DELTA XTEND 130742209Recalls & reported problems

Summary

The FDA's MAUDE database contains 52 adverse event reports that list this exact device (DI 10603295027553), received between Oct 9, 2017 and Jun 9, 2026 — classified as 48 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (21 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 52 reports, in the reporter's own words as published by the FDA.

• InjuryJun 9, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD DISCOMFORT, REVISED THE GLENOSPHERE AND POLY. AFFECTED SIDE-UNKNOWN SHOULDER

  Patient problems: Discomfort

  MAUDE report 25446772 ↗
• InjuryJan 6, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. IT WAS STATED THAT THE METEGLENE WAS LOOSE. LOOSENING INTERFACE WAS MARKED AS BONE TO IMPLANT INTERFACE. NO ADDITIONAL INFORMATION. DOI: (B)(6) 2025, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT.

  Patient problems: Unspecified Infection

  MAUDE report 23975988 ↗
• MalfunctionSep 9, 2025Difficult to Insert; Difficult to Insert

  IT WAS REPORTED INTRAOPERATIVELY IT WAS NOT POSSIBLE TO FIX THE INLAY INTO THE SIZE 10 MONOBLOC IMPLANT. ANOTHER INLAY WAS AVAILABLE AND USED WITHOUT ISSUE. NO PATIENT HARM AND NO SURGICAL DELAY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23008707 ↗
• InjurySep 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT IS CHRONICALLY UNSTABLE. SURGEON CHANGED GLENOSPHERE AND POLY IN AN ATTEMPT TO MAKE THEM MORE STABLE. AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Joint Laxity

  MAUDE report 22964222 ↗
• InjuryAug 22, 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 IMPINGEMENT ON THE GLENOID WHICH CAUSES INSTABILITY. SURGEON TOOK OUT SPACER AND WENT UP 6MM AND WAS STABLE. DOI: ON (B)(6) 2025, DOR: ON (B)(6) 2025, AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Joint Laxity

  MAUDE report 22879653 ↗
• MalfunctionJul 31, 2025Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT POLY DID NOT LOCK INTO THE SPACER SO USERS REPLACED BOTH THE POLY AND THE SPACER. THE DOCTOR WAS ABLE TO PULL IT OUT WITH HIS TWO FINGERS AFTER IMPACTING IT. DOE: (B)(6), 2025 AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22675450 ↗
• MalfunctionJun 13, 2025Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE SURGEON FELT LIKE THE POLY DID NOT FIT PROPERLY. DOE: (B)(6), 2025. AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22203910 ↗
• 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 BECAUSE THEY HAD AN INFECTION. SURGICAL DELAY WAS UNKNOWN. AFFECTED SIDE: UNKNOWN SHOULDER.

  Patient problems: Unspecified Infection

  MAUDE report 22008411 ↗
• InjuryJul 1, 2024Naturally Worn; Naturally Worn

  PATIENT WAS REVISED DUE TO INSTABILITY AND WEAR. SCAPULAR NOTCHING APPARENT ON X-RAY. REVISED TO MORE LATERALIZATION ON GLENOSPHERE AND ECCENTRICITY. DOI: ON (B)(6) 2022, DOR: ON (B)(6) 2024, AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Joint Laxity; Unspecified Tissue Injury

  MAUDE report 19646069 ↗
• InjuryMar 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INSTABILITY. SURGICAL DELAY WAS UNKNOWN. DOI: (B)(6) 2021; DOR: (B)(6) 2024; AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Laxity

  MAUDE report 18851909 ↗
• InjuryFeb 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. HE HAS HAD MULTIPLE FALLS. NO OTHER INFORMATION. IT WAS UNKNOWN IF THERE WAS ANY SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6), 2024. AFFECTED SIDE: LEFT.

  Patient problems: Fall; Pain

  MAUDE report 18717430 ↗
• InjuryJan 11, 2024Adverse 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. UNKNOWN SURGICAL DELAY. DOI: UNKNOWN, DOR: (B)(6) 2024, AFFECTED SIDE: UNKNOWN.

  Patient problems: Joint Laxity

  MAUDE report 18492359 ↗
• InjurySep 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT REVISION OF A REVERSE TOTAL SHOULDER PROSTHESIS. THE HUMERAL IMPLANT WAS A LONG MONOBLOCK DELTA XTEND CEMENTED IN PLACE. PATIENT REPORTED ISSUES WITH MOBILITY AND PAIN. DOI: UNKNOWN. DOR: (B)(6) 2023 AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Loss of Range of Motion; Pain

  MAUDE report 17710879 ↗
• InjuryMay 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO SHOULDER INSTABILITY. 42+8 GLENOSPHERE, +9 SPACER & +6 POLY WERE PUT IN. DELTA XTEND HUMERAL COMPONENT, METAGLENE & +9 SPACER WERE RETAINED. NO SURGICAL DELAY WAS THERE. DOI: UNKNOWN; DOR: (B)(6) 2023; AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Joint Laxity

  MAUDE report 16983655 ↗
• InjuryMay 2, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT UNDERWENT REVISION SURGERY DUE TO SHOULDER DISLOCATION FOLLOWING REVERSE FOR FRACTURE. A SECOND 9MM METAL SPACER AND NEW POLY WAS ADDED. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Joint Dislocation

  MAUDE report 16853071 ↗
• InjuryApr 18, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

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

  Patient problems: Joint Dislocation

  MAUDE report 16760933 ↗
• InjuryOct 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INSTABILITY. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2022, DOR: (B)(6) 2022, AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Joint Laxity

  MAUDE report 15600044 ↗
• InjuryOct 7, 2022Adverse 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) 2022, AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Joint Laxity

  MAUDE report 15565616 ↗
• MalfunctionSep 28, 2022Tear, Rip or Hole in Device Packaging; Device Contaminated During Manufacture or Shipping; Tear, Rip or Hole in Device Packaging; Device Contaminated During Manufacture or Shipping

  THE PLASTIC ENVELOPE HAD A SUSPICIOUS HOLE/ HOLES/ PERFORATION, THEREFOR THE RISK OF CONTAMINATION WAS RAISED. WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? NO. ACTION TAKEN WHEN EVENT OCCURRED? NEW IMPLANT CHOSEN, WAS PROCEDURE SUCCESSFULLY COMPLETED? YES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15498427 ↗
• InjurySep 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT CAME IN BECAUSE HIS WOUND WAS OOZING. SURGEON DECIDED IT BEST TO WASHOUT THE JOINT AND EXCHANGED THE POLY. SURGEON REMOVED A 42 +9 STD POLY AND IMPLANTED THE SAME. NO FURTHER PATIENT INFORMATION IS AVAILABLE AT THIS TIME. DOI: (B)(6) 2022, DOR: (B)(6) 2022, AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Fluid Discharge

  MAUDE report 15337406 ↗
• InjuryJun 27, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT HAS DISLOCATED MULTIPLE TIMES. REVISED POLY TO A RETENTIVE CUP AND ADDED A SPACER. DOI- (B)(6) 2022; DOR- (B)(6) 2022; AFFECTED SIDE- RIGHT SHOULDER.

  Patient problems: Joint Dislocation

  MAUDE report 14828776 ↗
• InjuryMay 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO INFECTION AND LOOSENING OF THE METAGLENE AT THE BONE TO IMPLANT INTERFACE. ALL IMPLANTS WERE REMOVED AND TEMPORARY SPACER PLACED IN. CULTURES SENT. THE SURGEON DESCRIBED THE PATIENT AS HAVING POOR PROTOPLASM AND GENERALLY UNHEALTHY OVERALL. DOI: (B)(6) 2018. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Unspecified Infection

  MAUDE report 14517401 ↗
• InjuryMay 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INSTABILITY. THERE WAS NO LOOSENING. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2020; DOR: (B)(6) 2022; AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Joint Laxity

  MAUDE report 14278785 ↗
• InjuryJan 24, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED DUE TO ANTERIOR DISLOCATION OF REVERSE ARTHROPLASTY. INDEX EPI POLY WAS REMOVED. IT WAS REPLACED WITH SPACER AND EPI POLY. DOI: (B)(6) 2021. DOR: (B)(6) 2022; AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Joint Dislocation

  MAUDE report 13333624 ↗
• InjurySep 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SURGERY: REVISION OF LEFT SHOULDER DELTA XTEND. REASON FOR REVISION - INFECTION. THE 42MM SCREW WAS VERY DIFFICULT TO REMOVE AND DELAYED THE OPERATION BY APPROXIMATELY ONE HOUR. INITIALLY UNLOCKED SCREW WITH LOCKING SCREWDRIVER INTERNAL ROD AND THEN USED LOCKING SCREWDRIVER (WITHOUT INTERNAL ROD) TO UNSCREW IT. HOWEVER ONE OF THE ¿PRONGS¿ FROM THE TOP OF THE SCREW SHEARED OFF SO THE LOCKING SCREW DRIVER WOULD NOT GRIP/ENGAGE PROPERLY TO UNSCREW IT. THE SURGEON HAD TO DRILL THROUGH THE SCREW CENTRALLY AND USE THE TRUSTS SCREW REMOVAL INSTRUMENTS TO REMOVE THE SCREW AND IT CAME OUT IN 3 OR 4 PARTS. ALL IMPLANTS WERE RETAINED BY THE HOSPITAL. NO ADVERSE CONSEQUENCES DURING SURGERY. PRIMARY SURGERY CONDUCTED ON - (B)(6) 2021.

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

  MAUDE report 12532003 ↗

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-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-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-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-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-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-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.