DELTA XTEND 130760142Recalls & reported problems

Summary

The FDA's MAUDE database contains 116 adverse event reports that list this exact device (DI 10603295027775), received between Sep 7, 2017 and Sep 16, 2026 — classified as 93 injuries, 23 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (41 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 116 reports, in the reporter's own words as published by the FDA.

• 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 50788120 ↗
• 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: Pain; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 23560202 ↗
• InjuryOct 23, 2025Fracture; Device Dislodged or Dislocated; Fracture; Device Dislodged or Dislocated

  IT WAS REPORTED THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2025, DUE TO A GLENOSPHERE SCREW BEING BROKEN AND THE GLENOSPHERE BEING LOOSE. THE DEVICES WERE FIRST IMPLANTED IN 2021.

  Patient problems: Insufficient Information

  MAUDE report 23367498 ↗
• InjurySep 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS REVISION OF DELTA XTEND DUE TO NOTCHING OF THE GLENOID AND PAIN. THE SURGEON REMOVED STANDARD POLY AND GLENNOSPHERE AND REPLACED IT WITH 42 MM ECCENTRIC +6 MM AND HM CUP.

  Patient problems: Extraskeletal ossification; Pain

  MAUDE report 23050343 ↗
• MalfunctionJun 30, 2025Difficult to Insert; Difficult to Insert

  DURING THE OPERATION, IT WAS NOT POSSIBLE TO INSTALL THE GLENOSPHERE INTO THE METAGLENE. ACCORDING TO THE SURGEON AND THE OPERATING NURSE, THE INSTALLATION WAS DONE ACCORDING TO THE TECHNIQUE. INITIALLY, THE GLENOSPHERE SCREW WAS POORLY INSERTED INTO THE METAGLENE. WHEN REMOVING IT, IT WAS POSSIBLE TO ESTABLISH THAT HALF OF THE GLENOSPHERE SCREW THREAD WAS CRUSHED. AS A RESULT, ANOTHER COMPONENT WAS INSTALLED. THE PATIENT WAS NOT INJURED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22364763 ↗
• 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 21979504 ↗
• InjuryJan 30, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THIS WAS A REVISION SHOULDER ARTHROPLASTY ON HUMERUS AND SHOULDER BLADE PERFORMED ON (B)(6) 2025. ABOUT THREE YEARS AGO, A PATIENT WHO HAD BEEN REPLACED WITH THE DXTEND WAS FOUND TO HAVE METALLOSIS. THEREFORE, THE PATIENT UNDERWENT REVISION SURGERY. THE SURGEON DEPLOYED THE AFFECTED AREA. THERE WAS SOME BLACK SOFT TISSUE FROM WITHIN THE JOINT, BUT THERE WAS NO INTERFERENCE BETWEEN THE SCREW AND POLYETHYLENE CUP PLACED IN THE METAGLEN. ALSO, THE POLYETHYLENE CUP DID NOT APPEAR WORN TO THE NAKED EYE. THE SURGEON REMOVED THE DXTEND GLENOSPHERE AND EXAMINED IT. THE SURFACE APPEARED FINE TO THE NAKED EYE, BUT THE CENTER SCREW SHOWED SOME DAMAGE. THE SURGEON COULD NOT EVEN CONFIRM THE SCAPULAR NOTCHING, SO HE REPLACED IT WITH THE SAME IMPLANT THAT HAD BEEN INSERTED IN THE PATIENTS, AND THE REVISION SURGERY WAS COMPLETED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Foreign Body Reaction

  MAUDE report 21275658 ↗
• 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 21043456 ↗
• InjuryOct 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT A PRIOR REVERSE DELTA XTEND AND NOW EXPERIENCING A BRACHIAL PLEXUS NEUROPATHY AND THE IMPLANTS HAD TO BE EXTRACTED TO HELP ALLEVIATE THIS.

  Patient problems: Hyporesponsive to stimuli; Neuropathy; Pain

  MAUDE report 20439085 ↗
• InjurySep 20, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED A REVISION SURGERY OCCURRED (B)(6) 2024 DUE TO DEVICE DISLOCATION. THERE WAS UNEVEN CONTACT BETWEEN GLENOSPHERE AND POLY LINER THAT THE CAUSED POLY LINER TO WEAR COMPLETELY ON THE INFERIOR SIDE. THE GLENOSPHERE WASHERS BECAME LOOSE. PATIENT EXPERIENCED SHOULDER LACK OF MOBILITY. THE GLENOSPHERE AND LINER WERE REPLACED. ORIGINAL IMPLANT DATE UNKNOWN.

  Patient problems: Joint Dislocation; Loss of Range of Motion

  MAUDE report 20272619 ↗
• InjuryJul 16, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT WAS DISLOCATING AND HAD SOME NOTCHING ON INFERIOR GLENOID. GLENOSPHERE (STD +0) AND CUP (42 +6 STD) WERE REMOVED. DOI: (B)(6) 2017. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Joint Dislocation

  MAUDE report 19751415 ↗
• InjuryApr 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION OF RIGHT REVERSE SHOULDER REPLACEMENT : PATIENT HAD NO ISSUES WITH SHOULDER UNTIL A FALL LAST OCTOBER IN WHICH HE HAS DAMAGED HIS GLENOID AND THE GLENOID COMPONENTS. WENT IN TO SHOULDER - HUMERAL COMPONENTS WELL FIXED, GLENOID COMPONENTS LOOSE AND SIGNIFICANT WEAR TO COMPONENTS BONE QUALITY WAS STILL GOOD SO REPLACED GLENOID COMPONENTS AND HUMERAL POLY. DOI: (B)(6) 2020 DOE: 18-APR-2024.

  Patient problems: Insufficient Information

  MAUDE report 19214072 ↗
• InjuryApr 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6), STUDY NO: (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR PERIPROSTHETIC INFECTION. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS NOT RELATED TO DEVICE OR PROCEDURE. DATE OF IMPLANT: (B)(6) 2023, DATE OF EVENT: (B)(6) 2024, (RIGHT SHOULDER). TREATMENT: I&D AND INJECTED MEDICATION.

  Patient problems: Unspecified Infection

  MAUDE report 19193504 ↗
• InjuryApr 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED: WHAT IS THE EVENT DATE? 15/03/24. WHAT IS THE EXPLANT DATE (MM/DD/YYYY)? (B)(6) 2024. CAN YOU PROVIDE THE SCHEDULED DATE OF REVISION SURGERY? (B)(6) 2024. IT WAS INDICATED THAT THERE WAS LOOSENING. ON WHAT INTERFACE DID THE LOOSENING OCCUR? STEM HUMERAL. PLEASE CONFIRM THE MANUFACTURER OF THE CEMENT PRODUCT. IS IT DEPUY MANUFACTURED? IF YES, PLEASE PROVIDE THE PRODUCT CODE AND LOT NUMBER OF THE CEMENT PRODUCT. STRYKER SIMPLEX. CAN YOU PROVIDE THE QUANTITY USED FOR THE CEMENT PRODUCT? 1. WAS THERE ANY SURGICAL DELAY RELATED TO THE EVENT? IF YES, WHAT IS THE DURATION OF THE DELAY? NO. IS THE BIOSTOP G, TRÄGER AN INSTRUMENT UTILIZED TO INSERT A CEMENT RESTRICTOR, A CEMENT RESTRICTOR TRIAL, OR THE DEFINITIVE CEMENT RESTRICTOR? DEFINITIVELY IMPLANT. IS SIZE 8 CORRECT? CAN YOU DESCRIBE WHAT WAS MEANT BY, "LEFT BEHIND IN PREVIOUS SURGERY"? WAS THE PREVIOUS SURGERY THE PRIMARY IMPLANTATION OR A REVISION PROCEDURE? PRIMARY POST FRACTURE. WHY WAS THE DEVICE LEFT BEHIND? THE SURGEON UNSCREWED THE INTRODUCER TIP DISENGAGING TIP INSTEAD OF PULLING IT OUT. WAS IT SUPPOSED TO BE TAKEN OUT? WAS IT STILL INSIDE THE PATIENT? IF INSIDE, WILL THERE BE A PROCEDURE FOR R

  Patient problems: Unspecified Infection

  MAUDE report 19030890 ↗
• InjuryApr 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION SHOULDER DELTA MOTION POST HUMERAL FRACTURE DUE TO INFECTION INFECTION AND LOOSENING AT THE STEM HUMERAL. THERE WAS NO SURGICAL DELAY.

  Patient problems: Unspecified Infection

  MAUDE report 19018723 ↗
• InjuryMar 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  EXPANSION OF PROTHESIS BECAUSE OF INFECTION. PATIENT IS STRONG SMOKER. PROCEDURE SUCCESSFULLY COMPLETED WITH NO DELAY.

  Patient problems: Unspecified Infection

  MAUDE report 18912933 ↗
• InjuryFeb 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION REVERSE TOTAL SHOULDER REPLACEMENT. PATIENT PRESENTED WITH PAINFUL SHOULDER. REVISION SURGERY PLANNED AND EXECUTED. REMOVAL OF GLENOSPHERE AND LINER PERFORMED AND REMOVAL OF INFERIOR OSTEOPHYTE FROM GLENOID NECK. IMPLANTATION OF LATERALIZED GLENOSPHERE AND NEW LINER PERFORMED. DID THE PATIENT EXPERIENCE AN ADVERSE EVENT SUCH AS INFECTION, NON-UNION, ALLERGIC REACTION, OSTEOPOROSIS, OVERLOADING, PAIN, DEGENERATIVE DISEASES, BLEEDING OR OOZING? --> YES, DID THE PATIENT REQUIRE REVISION SURGERY OR HARDWARE REMOVAL? --> YES, WAS DEVICE EXPLANTED? --> FALSE, DID PATIENT REQUIRE REVISION SURGERY? --> FALSE, PATIENT STATUS/ OUTCOME / CONSEQUENCES --> WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: --> UNKNOWN. IS THE PATIENT PART OF A CLINICAL STUDY --> NO. (B)(4). DEVICE PROPERTY OF -->PATIENT. DEVICE IN POSSESSION OF -->NONE. (B)(4). DEVICE PROPERTY OF -->PATIENT. DEVICE IN POSSESSION OF -->NONE. BY CHECKING THIS BOX I CERTIFY THAT ALL INFORMATION THAT ARE KNOWN/AVAILABLE HAS BEEN DISCLOSED. IF ANY NEW INFORMATION WILL BE MADE AVAILABLE, THE ADDITIONAL INFORMATION WILL BE SUBMITTED THROUGH CST.--> TRUE.

  Patient problems: Pain; Unspecified Musculoskeletal problem

  MAUDE report 18739199 ↗
• MalfunctionNov 13, 2023Difficult to Insert; Difficult to Insert

  WHILST SCREWING ON THE SIZE 42 STANDARD GLENOSPHERE, THE SURGEON COULD NOT ENGAGE THE THREAD INTO THE METAGLENE AND INITIALLY BELIEVE THE 3.5 CANNULATED SCREWDRIVER HEAD WAS CROSS THREADED. DUE TO MULTIPLE ATTEMPTS, THE SURGEON THEN REQUESTED THE SIZE 42 ECCENTRIC GLENOSPHERE AS THE STANDARD GLENOSPHERE HAD STRIPPED ITS INTERNAL SCREW THREAD. THE SAME PROBLEM WAS ENCOUNTERED WITH THE 42 ECCENTRIC GLENOSPHERE. SURGEON BELIEVED IT WASN'T ESSENTIALLY THE SCREWDRIVER BUT THE METAGLENE AND THAT IT WAS NOT ALLOWING THE GLENOSPHERE SCREW TO ENGAGE WITH IT. THE STANDARD METAGLENE AND SCREWS WAS THEN REMOVED AND REPLACED WITH A 10+ METAGLENE AND LONGER LOCKING SCREWS (CHANGED FROM 2 X 36 LOCKING SCREWS TO 2 X 42 LOCKING SCREWS) AND LEAVING THE SAME 2 X 18 NON LOCKING SCREWS. THE 42 ECCENTRIC METAGLENE WAS THEN REPLACED AND THERE WAS NO ISSUES WITH THE CANNULATED SCREWDRIVER WHEN SCREWING IT INTO THE NEW METAGLENE. SURGEON BELIEVE IT WAS THE METAGLENE (STANDARD INITIALLY USED) THAT WAS THE CAUSE OF THE GLENOSPHERES NOT ENGAGING. BOTH STANDARD METAGLENE AND 42 STANDARD GLENOSPHERE WILL BE CLEANED BY THE HOSPITAL SO THEY CAN BE RETURNED FOR INVESTIGATION. SURGERY WAS DELAYED 30 MINUTES DUE TO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18118548 ↗
• MalfunctionSep 13, 2023Difficult to Insert; Material Twisted/Bent; Difficult to Insert; Material Twisted/Bent

  THE THREADS ON THE GLENOSPHERE WERE VISUALIZED AFTER TRYING TO INSERT IT AFTER REMOVED THERE WAS DAMAGED THREADS VISIBLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17740333 ↗
• InjuryJul 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO CHRONIC INFECTION. ALL COMPONENTS REMOVED. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2010. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Unspecified Infection

  MAUDE report 17324373 ↗
• MalfunctionJul 10, 2023Difficult to Insert; Difficult to Insert

  INTRAOPERATIVELY DURING INITIAL SURGERY RIGHT SIDE IT WAS NOT POSSIBLE TO FIX THE GLENOSPHERE TO THE METAGLENE. ANOTHER GLENOSPHERE WAS AVAILABLE AND USED WITHOUT ANY ISSUE. NO SURGICAL DELAY, NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: Insufficient Information

  MAUDE report 17288931 ↗
• InjuryJun 26, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  SURGEON WAS REQUIRED TO REVISE A DELTA XTEND SHOULDER REPLACEMENT AS THE GLENOHUMERAL COMPONENTS DISLOCATED SUBSEQUENT TO THE PRIMARY OPERATION. SURGEON STATED DURING THE REVISION THAT HE SUSPECTS THE DISLOCATION WAS AS A RESULT OF THE HUMERAL COMPONENT IMPINGING ON THE SCAPULA. DOI: (B)(6) 2023. DOE: (B)(6) 2023. AFFECTED SIDE: UNKNOWN.

  Patient problems: Joint Dislocation; Joint Laxity

  MAUDE report 17200357 ↗
• InjuryJun 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO A +15 LONG PEGGED METAGLENE, 3 SCREWS THROUGH BASEPLATE, A 42 STANDARD GLENOSPHERE, AND A 42/+3 POLY. THE ENTIRE HUMERAL STEM WAS RETAINED AND NOT CHANGED. UNFORTUNATELY HE IS CONFIRMED FOR AN INFECTION IN SURGERY TODAY. ALL PARTS AND PIECES WERE REMOVED FROM THE PATIENT AND AN ANTIBIOTIC SPACER WAS PLACED TO TREAT THE INFECTION. DOI: (B)(6) 2020. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Unspecified Infection

  MAUDE report 17144445 ↗
• InjuryJun 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION OF A GLENOSPHERE COMPONENT AND THE CHANGE OF TWO SCREWS FROM METAGLENE BASE PLATE RIGHT SIDE. PATIENT WAS EXPERIENCING IMPINGEMENT AND PAIN FROM THIS. SURGEON CHANGED THE COMPONENT TO HELP REDUCE THE IMPINGEMENT PAIN THE PATIENT WAS EXPERIENCING. TWO SCREWS FROM THE ORIGINAL PRIMARY SURGERY EXCHANGED TO SMALLER LENGTHS WHILE IN THE CASE DUE THE LENGTH BEING TOO LONG. NO DISCOMFORT EXPERIENCED BY THE PATIENT FOR THIS, SURGEON EXCHANGED AS HE WAS IN THERE FOR THE GLENOSPHERE SWAP.

  Patient problems: Joint Laxity; Pain

  MAUDE report 17077976 ↗
• InjuryMay 16, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON (B)(6)2021, RADIOGRAPH SHOWS RIGHT SHOULDER HAS LUXATED AGAIN. ON *(B)(6)2021, REVISION OF RIGHT SHOULDER TEP. THE DELTA EXTEND MODEL IS REMOVED AND ANOTHER TEP FORM EXACTECH, EQUINOX REVERSE MODEL WAS USED. THE SHAFT WAS NOT REPLACED. DOI: (B)(6)2021; DOR: (B)(6)2021; RIGHT SHOULDER.

  Patient problems: Joint Dislocation; Loss of Range of Motion

  MAUDE report 16942292 ↗

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-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-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.
• 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-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-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-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.