DELTA XTEND 130790030Recalls & reported problems

Summary

The FDA's MAUDE database contains 132 adverse event reports that list this exact device (DI 10603295027843), received between Aug 31, 2017 and Apr 20, 2026 — classified as 105 injuries, 27 malfunctions.

The most frequently reported specific device problem is “Fracture” (20 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 132 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 20, 2026Fracture

  IT WAS REPORTED THAT DURING A PRIMARY REVERSE SHOULDER ARTHROPLASTY SURGERY, WHILE THE SURGEON WAS PERFORMING ROUTINE REMOVAL OF A LOCKING SCREW UNDER STANDARD CONDITIONS AND WITHOUT EXCESSIVE FORCE, THE SCREW HEAD AND A PORTION OF THE SCREW FRACTURED, LEAVING A FRAGMENT EMBEDDED IN THE PATIENT¿S BONE AND CAUSING A 15-MINUTE SURGICAL DELAY. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: Foreign Body In Patient

  MAUDE report 24927923 ↗
• 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 24873377 ↗
• 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 24873375 ↗
• InjuryApr 11, 2026Adverse Event Without Identified Device or Use Problem

  REMOVAL OF SHOULDER COMPONENTS DUE TO DEEP INFECTION OF THE LEFT SHOULDER JOINT. DEVICES WERE DISCARDED.

  Patient problems: Unspecified Infection

  MAUDE report 24851885 ↗
• MalfunctionApr 10, 2026Fracture

  IT WAS REPORTED THAT DURING AN ANTI-SHOULDER JOINT REPLACEMENT SURGICAL PROCEDURE, WHEN THE SCREW WAS INSERTED, THE SCREW WAS BROKEN. IT WAS REPORTED THAT ALL THE PIECES WERE REMOVED FROM THE PATIENT. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24844943 ↗
• InjuryFeb 25, 2026Osseointegration Problem

  IT WAS REPORTED THAT FAILED GLENIOD DISTAL STEM LEFT IN PLACE. IT WAS STATED THAT BASE PLATE AND SCREWS WERE LOOSE. LOOSENING INTERFACE WAS MARKED AS NON-CEMENTED. DOI: (B)(6) 2024. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Inadequate Osseointegration

  MAUDE report 24443250 ↗
• InjuryFeb 25, 2026Osseointegration Problem

  IT WAS REPORTED THAT FAILED GLENIOD DISTAL STEM LEFT IN PLACE. IT WAS STATED THAT BASE PLATE AND SCREWS WERE LOOSE. LOOSENING INTERFACE WAS MARKED AS NON-CEMENTED. DOI: (B)(6) 2024. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Inadequate Osseointegration

  MAUDE report 24443229 ↗
• InjuryFeb 25, 2026Osseointegration Problem

  IT WAS REPORTED THAT FAILED GLENIOD DISTAL STEM LEFT IN PLACE. IT WAS STATED THAT BASE PLATE AND SCREWS WERE LOOSE. LOOSENING INTERFACE WAS MARKED AS NON-CEMENTED. DOI: (B)(6) 2024. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Inadequate Osseointegration

  MAUDE report 24443115 ↗
• 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 24223667 ↗
• 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 24223648 ↗
• 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 24211289 ↗
• InjuryDec 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  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 23935667 ↗
• InjuryDec 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ALL IMPLANTS WERE REMOVED DUE TO INFECTION. AFFECTED SIDE- RIGHT SHOULDER.

  Patient problems: Unspecified Infection

  MAUDE report 23818384 ↗
• 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 23815144 ↗
• 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 23815140 ↗
• 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 23692410 ↗
• 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 22717643 ↗
• InjuryJul 16, 2025Fracture; Fracture

  IT WAS REPORTED THAT PATIENT FELT A POP IN THEIR SHOULDER AND WENT IN FOR A CHECKUP. UNFORTUNATELY, 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: Insufficient Information

  MAUDE report 22520575 ↗
• InjuryJul 16, 2025Fracture; Fracture

  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: Insufficient Information

  MAUDE report 22520571 ↗
• 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 22462415 ↗
• MalfunctionJun 12, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE SCREW TIP BROKE OFF DURING IMPLANTATION. SCREW REMAINED IMPLANTED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED BUT IT WAS UNKNOWN IF THERE WAS A SURGICAL DELAY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22199460 ↗
• MalfunctionJun 10, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE DELTA SCREW BROKE DURING INSERTION. SURGERY WAS DELAYED BY FIVE MINUTES. A NEW SCREW WAS USED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. FRAGMENTS WERE EASILY REMOVED WITHOUT REQUIRING ADDITIONAL INTERVENTION. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22174650 ↗
• InjuryJun 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  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 Tissue Injury

  MAUDE report 22136062 ↗
• MalfunctionMay 19, 2025Fracture; Fracture

  IT WAS REPORTED THAT PATIENT UNDERWENT ARTHROPLASTY ON (B)(6) 2025. THE CROWN PART OF THE SCREW GOT CHIPPED OFF WHILE TIGHTENING IT. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22046167 ↗
• InjuryFeb 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD SOME ANTERIOR SHOULDER PAIN, BELIEVED TO BE RELATED TO THE PATIENT'S SUBSCAP REPAIR. SURGEON SAID THE BONE SCAN SHOWED THE METAGLENE TO POTENTIALLY BE LOOSE. THE SURGEON REMOVED THE GLENOSPHERE AND SCREWS TO ASSESS THE METAGLENE. IT WAS WELL FIXED, BUT THE SURGEON FELT IT WAS BEST TO REPLACE IT BECAUSE OF THE STRESS PUT ON THE METAGLENE WHILE TESTING IT OUT. THERE WERE NO DELAYS. NO COMMENTS OR CONCERNS WERE EXPRESSED ABOUT THE QUALITY OF PRODUCTS. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Pain; Unspecified Tissue Injury

  MAUDE report 21307388 ↗

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-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-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-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-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-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-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-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.