DELTA XTEND 130760000Recalls & reported problems

Summary

The FDA's MAUDE database contains 223 adverse event reports that list this exact device (DI 10603295027737), received between Aug 9, 2017 and Sep 21, 2026 — classified as 194 injuries, 29 malfunctions.

The most frequently reported specific device problem is “Osseointegration Problem” (37 reports).

10 other recalls cover devices cleared under the same FDA submission (K062250, 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. 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 223 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 21, 2026Difficult to Insert

  It was reported that intraoperatively it was not possible to fix both glenospheres in the metaglene. Another glenosphere and another metaglene were used, and the surgery was completed. The surgical delay was about 30 minutes. All available information has been disclosed.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50841562 ↗
• InjurySep 17, 2026Osseointegration Problem

  Patient problems: Inadequate Osseointegration; Unspecified Infection

  MAUDE report 50810902 ↗
• 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 50787462 ↗
• InjuryAug 19, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that an Infection had occurred. Everything had came out. An antibiotic spacer had been placed. No additional information was available .DOI-(b)(6) 2017.DOR-(b)(6) 2026.Affected side-Left.

  Patient problems: Unspecified Infection

  MAUDE report 50322164 ↗
• InjuryMay 27, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT REVISED DUE TO INFECTION. EVERYTHING TAKEN OUT. DOI: (B)(6) 2024, DOR: (B)(6) 2026, AFFECTED SIDE: LEFT.

  Patient problems: Unspecified Infection

  MAUDE report 25303416 ↗
• InjuryApr 14, 2026Osseointegration Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO GLENOID BASEPLATE1 LOOSENING. LOOSENING INTERFACE WAS MARKED AS BONE TO IMPLANT. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Inadequate Osseointegration

  MAUDE report 24873288 ↗
• InjuryApr 2, 2026Use of Device Problem; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT UNDERWENT THE REVISION SURGERY DUE TO FRACTURE OF THE GLENOSPHERE´S SCREW. BASED ON THE PATIENT'S HISTORY AND IMAGING, THE MATERIAL FAILURE APPEARS TO HAVE BEEN CAUSED BY GROSS MISPLACEMENT OF THE METAGLENE WITH INSUFFICIENT FIT BETWEEN THE GLENOSPHERE AND METAGLENE. THIS RESULTED IN YEARS OF ABNORMAL NOTCHING, CREATING A MECHANICAL LEVER ON THE GLENOSPHERE AND ULTIMATELY LEADING TO FRACTURE OF THE COUPLING SCREW. IMPLANTATION DATE: (B)(6) 2024. AFFECTED SIDE: LEFT SIDE.

  Patient problems: Insufficient Information

  MAUDE report 24772130 ↗
• 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 24307542 ↗
• InjuryJan 30, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS A REMOVAL OF A SUSPECTED INFECTED DELTA XTEND SHOULDER IMPLANT FROM THE RIGHT SHOULDER DURING AN ARTHROPLASTY PROCEDURE. GLENOID METAGLENE WAS WELL FIXED IN GLENOID. PURULENT DISCHARGE WAS OBSERVED WITHIN THE HUMERAL CANAL, AND INTRAOPERATIVE SWABS WERE COLLECTED FOR ANALYSIS. THE WOUND AND HUMERAL CANAL WERE IRRIGATED WITH BETADINE, HYDROGEN PEROXIDE AND NORMAL SALINE, AND THE A CEMENT SPACER WITH VANCOMYCIN WAS IMPLANTED. THE ORIGINAL DELTA XTEND IMPLANT HAD BEEN PLACED DUE TO FAILURE OF A PREVIOUS ORIF (NON-UNION) WITH PLATE AND SCREWS. THE GLENOID METAGLENE WAS WELL FIXED IN THE GLENOID AT THE TIME OF EXPLANT. THE PATIENT'S INFECTION IS NOT CONFIRMED YET.

  Patient problems: Insufficient Information

  MAUDE report 24223654 ↗
• InjuryJan 29, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A FRACTURE AND JOINT INSTABILITY, NECESSITATING A REVISION PROCEDURE IN WHICH THE ORIGINAL IMPLANTS WERE REPLACED WITH A CTA HEAD FOR INCREASED STABILITY. DOI: (B)(6) 2021, DOR: (B)(6) 2026, AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Bone Fracture(s); Joint Laxity

  MAUDE report 24211257 ↗
• InjuryJan 13, 2026Osseointegration Problem; Migration

  IT WAS REPORTED THAT DXTEND MODULAR HUM STEM D12 HA, DXTEND METAGLENE, DXTEND GLENOSPHERE ECC D38MM, DXTEND MOD EPI 1 ECC LEFT HA, UNK SHOULDER HUMERAL CUP DELTA XTEND, UNKNOWN SHOULDER LOCKING SCREW, AND UNKNOWN SHOULDER NON-LOCKING SCREW WERE INVOLVED IN A REPORTED EVENT DURING A TOTAL SHOULDER REPLACEMENT REVISION. THE REVISION WAS PERFORMED DUE TO PAIN AND LOOSENING, WITH THE GLENOID NOTED AS SIGNIFICANTLY INCLINED. THE SURGEON REVISED TO A DIFFERENT PROSTHESIS. POLYETHYLENE EDGE LOADING CAUSED UNNATURAL WEAR, AND THE EPIPHYSIS WAS REMOVED WITH LITTLE EFFORT. THE STEM WAS WELL FIXED, REQUIRING AN OSTEOTOMY FOR REMOVAL. THE GLENOSPHERE WAS REMOVED WITHOUT ISSUE, BUT THERE WAS DIFFICULTY REMOVING SCREWS, NECESSITATING SPECIAL INSTRUMENTS TO REMOVE SCREW HEADS. THE METAGLENE AND REMAINING SCREW FRAGMENTS WERE REMOVED, AND A CABLE SET WAS USED FOR THE OSTEOTOMY. METAL FRAGMENTS FROM THE SCREW REMOVAL SET WERE GENERATED BUT WERE REMOVED WITHOUT ADDITIONAL INTERVENTION. THE PROCEDURE WAS NOT DELAYED, WAS COMPLETED SUCCESSFULLY, AND NO FURTHER MEDICAL INTERVENTION WAS REQUIRED. THERE WERE NO REPORTED PATIENT CONSEQUENCES.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 24056991 ↗
• InjuryDec 31, 2025Fracture; Device Dislodged or Dislocated; Fracture; Device Dislodged or Dislocated

  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 23935488 ↗
• 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 23815141 ↗
• InjuryNov 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT THE REMOVAL OF DELTA XTEND SHOULDER DUE TO PAIN AND SUSPECTED INFECTION. SURGEON REQUESTED THE POSITION OF THE GLENOSPHERE AND THAT THE PATIENT WAS 'NOTCHING'. THERE WAS ALSO A FRACTURED ACROMIUM. THIS SUGGESTED THE DELTOID WAS UNDER SEVERE TENSION WHEN IMPLANT INSERTED. THE DELTA XTEND WAS REMOVED AND A DJO ALTIVATE REVERSE SHOULDER WAS IMPLANTED.

  Patient problems: Bone Fracture(s); Pain; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 23560190 ↗
• InjuryNov 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION OF REVERSE LEFT SHOULDER. REASON FOR REVISION ¿ INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 23558555 ↗
• 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 23372450 ↗
• InjuryOct 17, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THERE IS A DELTA EXTEND REVISION PLANNED ON (B)(6) 2025 WHERE GLENOSPHERE SCREW IS BROKEN AND GLENOSPHERE IS LOOSE. FIRST TIME IMPLANTED 2021.

  Patient problems: Insufficient Information

  MAUDE report 23327772 ↗
• InjurySep 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Joint Laxity

  MAUDE report 23031120 ↗
• InjuryAug 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION OF SHOULDER. ALL IMPLANTS REMOVED. DOI: (B)(6) 2021. DOR: (B)(6) 2025. AFFECTED SIDE: UNKNOWN SHOULDER.

  Patient problems: Unspecified Infection

  MAUDE report 22717600 ↗
• InjuryJul 16, 2025Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT PATIENT FELT A POP IN THEIR SHOULDER AND WENT IN FOR A CHECKUP. X-RAYS SHOWED THE GLENOSPHERE HAD BROKEN LOOSE, LEAVING A COUPLE BROKEN SCREWS IN THE GLENOID. WHEN REVISING, SURGEON FELT THE STEM WAS STABLE, SO SURGEON DIDN¿T WANT TO REVISE THE HUMERAL COMPONENT. SURGEON WAS ABLE TO REMOVE THE GLENOSPHERE AND BROKEN SCREWS AND SUCCESSFULLY PREP THE GLENOID FOR A NEW BASEPLATE AND GLENOSPHERE. A NEW EPI AND POLY WERE IMPLANTED AS WELL. STABILITY OF THE SHOULDER WAS CONFIRMED AND THE CLOSING PROCESS BEGAN. THERE WAS NO DELAYS OR ADVERSE EVENTS TOOK PLACE. DOI: (B)(6) 2023, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Inadequate Osseointegration

  MAUDE report 22520572 ↗
• 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 22462407 ↗
• 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 22293593 ↗
• 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 22160949 ↗
• InjuryJun 3, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  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 Musculoskeletal problem; Unspecified Tissue Injury

  MAUDE report 22136036 ↗
• InjuryMay 7, 2025Osseointegration Problem; Osseointegration 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: Inadequate Osseointegration; Unspecified Infection

  MAUDE report 21979565 ↗

Recalls under the same FDA submission

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