DELTA XTEND 130760038Recalls & reported problems

Summary

The FDA's MAUDE database contains 77 adverse event reports that list this exact device (DI 10603295027744), received between Aug 9, 2017 and Aug 19, 2026 — classified as 66 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (31 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 25 most recent of 77 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 19, 2026Difficult to Insert; Material Deformation

  It was reported that DXTEND GLENOSPHERE ECC D38MM was used during reverse shoulder arthroplasty. During implantation, the threads stripped and the device could not lock onto the base. The device was removed and replaced with another device to complete the procedure. There were no adverse consequences to the patient, and the procedure was prolonged by 15 minutes. The implant was removed intraoperatively, and a replacement implant was used.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50329123 ↗
• MalfunctionJun 8, 2026Difficult to Insert; Material Deformation

  IT WAS REPORTED THAT THE SURGEON COULD NOT IMPLANT. THE DEVICE WAS STRIPPED, AND THE IMPLANT WAS WASTED. THE HOSPITAL HAS DISPOSED OF IT. AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25436177 ↗
• InjuryJan 5, 2026Adverse Event Without Identified Device or Use Problem

  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: Pain

  MAUDE report 23957467 ↗
• InjuryDec 2, 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 PAIN. AFFECTED SIDE: UNKNOWN SHOULDER.

  Patient problems: Pain

  MAUDE report 23692326 ↗
• 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 23372445 ↗
• InjuryJun 3, 2025Fracture; Device Dislodged or Dislocated; Fracture; 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 22136027 ↗
• InjuryFeb 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REMOVAL OF ALL DELTA XTEND IMPLANTS DUE TO INFECTION. SURGEON DID ORIGINAL OPERATION IN 2020 AND FIRST REVISION 2 MONTHS LATER FOR DISLOCATION. NO SURGICAL DELAY.

  Patient problems: Unspecified Infection

  MAUDE report 18702637 ↗
• InjuryAug 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A RIGHT DELTA XTEND REVERSE SHOULDER REPLACEMENT APPROXIMATELY 6 MONTHS AGO. PATIENT REPRESENTED TO SURGEON COMPLAINING OF PAIN, UNEXPLAINED ORIGIN. PROCEDURE; FIRST STAGE REVISION OF ALL COMPONENTS AND INSERTION OF GLOBAL AP HEMIARTHROPLASTY CEMENT 'SPACER'. UPON OPENING THE SHOULDER AND EXAMINING THE JOINT THE SURGEON SUSPECTED A LOW GRADE INFECTION WAS PRESENT. MULTIPLE SPECIMENS AND SWABS WERE TAKEN. DOI: UNKNOWN, DOE: (B)(6) 2023, AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 17480073 ↗
• InjuryMar 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT RIGHT-SIDED REVERSE TOTAL SHOULDER I&D WAS PERFORMED FOR UNKNOWN REASON. DOI: (B)(6) 2014. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Insufficient Information

  MAUDE report 16466486 ↗
• InjuryDec 13, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT DISLOCATED REVERSE TOTAL SHOULDER AND NEEDED TO BE REVISED. THE GLENOSPHERE WAS CHANGED FROM +0 ECC TO +6 ECC. THE CUP WAS CHANGED FROM +3 STD TO +6 RETENTIVE. THE +9 SPACER WAS CHANGED FOR A NEW +9 SPACER. DOI: (B)(6) 2018; DOR: (B)(6) 2022; AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Joint Dislocation

  MAUDE report 15968538 ↗
• InjurySep 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. ALL PARTS AND PIECES WERE REMOVED TO TREAT THE INFECTION. DOI: (B)(6) 2016, DOR: (B)(6) 2022, AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Unspecified Infection

  MAUDE report 15484838 ↗
• InjuryAug 30, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT REVISED TO ADDRESS PAIN AND LOOSENING OF THE GLENOSPHERE AND 18 MM NON LOCKING SCREW AT THE BONE TO IMPLANT INTERFACE. EPI, GLENOSPHERE, POLY AND ONE SCREW WERE EXCHANGED. DOI: UNKNOWN, DOR: (B)(6) 2022, AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Pain

  MAUDE report 15321466 ↗
• InjuryJul 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED FOR HAVING SCAPULAR NOTCHING DUE TO LOOSE SOFT TISSUE TENSION. THE SURGEON IMPLANTED A 42 + 4 ECC GLENOSPHERE AND A 42 + 6 POLY. THERE WAS NO REPORTED LOOSENING. IT WAS UNKNOWN IF ANY SURGICAL DELAY REPORTED. DOI: (B)(6) 2012; DOR: (B)(6) 2022; AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Joint Laxity; Unspecified Tissue Injury

  MAUDE report 15131066 ↗
• InjuryJun 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. DOI: UNKNOWN. DOR: (B)(6) 2022, AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Unspecified Infection

  MAUDE report 14829368 ↗
• InjuryMay 13, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO CHRONIC DISLOCATION. LATERALIZED GLENOSPHERE AND A NEW POLY WERE IMPLANTED. DOI: (B)(6) 2019; DOR: (B)(6) 2022; AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Joint Dislocation

  MAUDE report 14395519 ↗
• InjuryDec 20, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT HUMERAL STEM WAS NOT EXPLANTED AND THERE WAS NO SURGICAL DELAY REPORTED.

  Patient problems: Unspecified Infection

  MAUDE report 13044286 ↗
• MalfunctionJul 20, 2021Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THIS WAS AN RSA PERFORMED ON (B)(6) 2021. THE GLENOSPHERE WAS NOT ABLE TO BE DEPLOYED APPROPRIATELY. THE PROCEDURE WAS COMPLETED WITH A REPLACEMENT LESS THAN 30-MINUTE SURGICAL DELAY. THERE WAS NO HARM TO THE PATIENT. THE DEVICE WAS BRAND NEW AND THE FIRST USE WHEN THE ISSUE OCCURRED. IT WAS NOT FULLY DESCRIBED HOW INAPPROPRIATE THE DEPLOYMENT WAS. THE PATIENT IS EXPECTED TO TAKE MEDICAL FOLLOW-UP.

  Patient problems: Insufficient Information

  MAUDE report 12195596 ↗
• MalfunctionMay 4, 2021Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  AFTER THE FIRST OPENING OF THE PACKAGING BY THE GROOMER, THE SALES REP TOOK THE DEVICE AND SHE FELT LIKE THE ASPECT OF THE DEVICE WAS NOT AS USUAL. SOME AIR WAS PRESENT IN THE POUCH. SO THE DEVICE WAS NOT STERILE ANYMORE. IMMEDIATE USE OF ANOTHER DEVICE TO COMPLETE THE PROCEDURE. NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11769237 ↗
• InjuryApr 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REMOVAL OF OLD COMPONENTS FOR INFECTION AND ANOTHER COMPANY CEMENT SPACER WENT IN. DOI: (B)(6) 2021, DOR: (B)(6) 2021, UNK SHOULDER.

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

  MAUDE report 11711527 ↗
• InjuryMar 25, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INSTABILITY. GLENOSPHERE AND POLY EXCHANGED TO ENHANCE STABILITY. NO SURGICAL DELAY. DOI: UNKNOWN, DOR: (B)(6) 2021, LEFT SHOULDER.

  Patient problems: Joint Laxity

  MAUDE report 11568375 ↗
• MalfunctionMar 23, 2021Difficult to Insert; Difficult to Insert

  INTRAOPERATIVELY DURING PRIMARY SHOULDER-TEP UNKNOWN SIDE IT WAS NOT POSSIBLE TO CONNECT THE GLENOSPHERE TO THE METAGLENE. ANOTHER GLENOSPHERE WAS AVAILABLE AND PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT HARM, NO ADVERSE CONSEQUENCES. SURGICAL DELAY 10 MIN.

  Patient problems: Insufficient Information

  MAUDE report 11553209 ↗
• InjuryMar 11, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THIS COMPLAINT CAPTURES THE FIRST REVISION DUE TO "CHRONIC DISLOCATION" STATED ON (B)(4). DOI: (B)(6) 2016. DOR: (B)(6) 2017; LEFT SHOULDER.

  Patient problems: Joint Dislocation

  MAUDE report 11463373 ↗
• InjuryFeb 17, 2021Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INSTABILITY. STABILITY WAS RESTORED WITH PLUS 4 GLENOSPHERE. NO SURGICAL DELAY REPORTED. DOI: (B)(6) 2017; DOR: (B)(6) 2021; LEFT SHOULDER.

  Patient problems: Joint Laxity

  MAUDE report 11337877 ↗
• InjuryJan 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS PAINFUL SHOULDER. SURGEON REVISED WITH LATERALIZED GLENOSPHERE AND THICKER POLY WITH SPACER. DOI: (B)(6) 2018, DOR: (B)(6) 2021, RIGHT SHOULDER.

  Patient problems: Pain

  MAUDE report 11252436 ↗
• MalfunctionDec 1, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS DETERMINED AFTER TESTING THAT PATIENT HAD AN INFECTION WHICH WOULD REQUIRE A STAGE 1 REMOVAL OF ALL DEPUY REVERSE SHOULDER IMPLANTS. DURING THE SURGICAL CASE THE SURGEON WAS ATTEMPTING TO EXTRACT THE HUMERAL STEM. AFTER CONNECTING TO THE STEM WITH THE IMPACTION HANDLE, HE BEGAN TO TAP THE TOP FLANGE OF THE HANDLE WITH THE SLOTTED MALLET (REF. # (B)(4), LOT # SO2029058) THAT IS INCLUDED IN THE SHOULDER REMOVAL INSTRUMENT SET. WHILE USING THE POLY TIPPED END OF THE MALLET TO DO THIS, THE POLY TIP SHEARED OFF AND LANDED ON THE FLOOR. THE HUMERAL STEM WAS THEN REMOVED EASILY WITHOUT FURTHER INCIDENT. A FEW MINUTES LATER, DURING THE REMOVAL OF THE METAGLENE LOCKING SCREWS (3 IN TOTAL), AS THE SURGEON WAS REMOVING THE FINAL SCREW, ONE OF THE TABS ON THE END OF THE LOCKING SCREWDRIVER (REF. # (B)(4), LOT # 5285866) BROKE OFF AND ALSO LANDED ON THE OPERATING ROOM FLOOR. SINCE THE SCREW WAS ALREADY LOOSE AND ABOUT TO COME FREE OF THE METAGLENE, THE SURGEON WAS ABLE TO PULL IT FREE. ALL IMPLANTS WERE REMOVED AS PLANNED WITHOUT ADDITIONAL SURGICAL TIME OR INJURY TO THE PATIENT. DOI: (B)(6) 2018. DOR: (B)(6) 2020. LEFT SHOULDER.

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

  MAUDE report 10928659 ↗

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-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-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-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-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-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-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.