DELTA XTEND 130742206Recalls & reported problems

Summary

The FDA's MAUDE database contains 99 adverse event reports that list this exact device (DI 10603295027546), received between Jul 13, 2017 and Sep 8, 2026 — classified as 94 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (48 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 99 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 8, 2026Difficult to Insert; Off-Label Use

  Patient problems: Insufficient Information

  MAUDE report 50675464 ↗
• InjuryJul 13, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT SURGEON REMOVED A 42 +6 HUMERAL CUP AND A 42 + 6 LATERALIZED GLENOSPHERE BECAUSE PATIENT WAS DISLOCATING AND PUT IN A 42 + 8 GLENOSPHERE AND A +9 HUMERAL SPACER AND A 42 +3 HUMERAL CUP. DOI: (B)(6) 2025. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Joint Dislocation

  MAUDE report 25796835 ↗
• InjuryJul 9, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT REMOVED A 42 +6 HUMERAL CUP AND A 42 + 6 LATERALIZED GLENOSPHERE BECAUSE PATIENT WAS DISLOCATING AND PUT IN A 42 + 8 GLENOSPHERE AND A +9 HUMERAL SPACER AND A 42 +3 HUMERAL CUP. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Joint Dislocation

  MAUDE report 25764453 ↗
• InjuryJun 9, 2026Improper or Incorrect Procedure or Method; Device Dislodged or Dislocated; Naturally Worn

  IT WAS REPORTED THAT PATIENT WAS DISLOCATING AND HAD HUMERAL CUP WEAR. IT WAS NOTICED THAT THE WRONG SIZE HUMERAL CUP WAS INSERTED DURING THE INITIAL PROCEDURE. IT SHOULD HAVE BEEN A 38 CUP INSTEAD OF A 42. THIS WAS DONE AT A DIFFERENT ACCOUNT BY ANOTHER REP. SURGEON REMOVED THE STEM, GLENOSPHERE, AND HUMERAL CUP AND CEMENTED IN A STEM, USED A NEW GLENOSPHERE AND HUMERAL CUP. NO SURGICAL DELAY. AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Joint Dislocation

  MAUDE report 25445178 ↗
• InjuryApr 27, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT EXPERIENCED PAIN FROM NOTCHING. SURGEON ELECTED TO TAKE GLENOSPHERE OUT AND PUT IN ECCENTRIC LATERALIZED GLENOSPHERE. SURGEON ALSO PUT IN THICKER POLY. DOI: (B)(6) 2017. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Bone Notching; Pain

  MAUDE report 25002344 ↗
• InjuryApr 10, 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 24844558 ↗
• InjuryNov 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS COMPLAINING OF HUMERAL PAIN. STEM WAS FOUND TO BE IN GOOD STABLE CONDITION AS WELL AS METAGLENE. SURGEON REPLACED SCREWS, GLENOSPHERE AND PLOY TO BIGGER SIZES TO GIVE MORE STABILITY. DOI: (B)(6) 2024. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Joint Laxity; Pain

  MAUDE report 23488260 ↗
• InjurySep 16, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS DISLOCATING SO SURGEON SWAPPED PARTS. DOI: UNKNOWN, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Joint Dislocation

  MAUDE report 23066178 ↗
• InjuryAug 4, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT'S SHOULDER WAS DISLOCATING. THE SURGEON ADDED A SPACER AND RETENTIVE POLY. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Joint Dislocation

  MAUDE report 22701731 ↗
• InjuryJul 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAS INSTABILITY AND WAS REVISED FROM A GLENOSPHERE AND POLY TO A MORE LATERALIZED CONSTRUCT. THERE WAS NO REPORTED IMPLANT FAILURE; ALL PIECES WERE REMOVED AND RETRIEVED. THE COLLETT WAS CHANGED. THERE WAS NO SURGICAL DELAY OR ADVERSE REACTION TO THE PATIENT. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Joint Laxity

  MAUDE report 22479918 ↗
• InjuryApr 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY FOR THE LEFT SHOULDER. INITIALLY THE PATIENT UNDERWENT REVERSE SHOULDER REPLACEMENT DUE TO A FRACTURED LEFT HUMERUS. A COUPLE OF WEEKS LATER THE PATIENT'S JOINT HAD DISLOCATED. THE GLENOSPHERE CHANGED AT THAT TIME TO LATERALIZED +0 MM 42MM STANDARD GLENOSPHERE; AND PE CUP 42+6MM. FOLLOWING THIS SECOND OPERATION, THE SURGICAL WOUND DEHISCED AND LOOKS INFECTED. THE PATIENT WENT BACK TO THEATRE AND HAD SPECIMENS TAKEN AND THE JOINT WASHED OUT. THE GLENOSPHERE AND CUP WERE REMOVED. NEW GLENOSPHERE 42MM AND STANDARD 42 +6MM PE CUP IMPLANTED. NO IMPLANTS TO RETURN AS RETAINED BY HOSPITAL.

  Patient problems: Unspecified Infection; Wound Dehiscence

  MAUDE report 21880826 ↗
• InjuryApr 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INFECTED POLY AND GLENOSPHERE. NO PROBLEMS, SURGERY WENT SMOOTH. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Unspecified Infection

  MAUDE report 21880562 ↗
• InjuryNov 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENTS LEFT SHOULDER IS BEING REVISED DUE TO INSTABILITY. DOI: (B)(6) 2021. DOR: (B)(6), 2024. AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Joint Laxity

  MAUDE report 20752706 ↗
• InjuryOct 25, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO DISLOCATION. REVISED POLY WITH METAL SPACER AND NEW POLY. INCREASED SPACE 6MM. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Joint Dislocation

  MAUDE report 20534340 ↗
• InjurySep 24, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT WAS REVISED DUE TO SHOULDER DISLOCATION. REVISED WITH NEXT THICKNESS POLY AND WAS STABLE. UNKNOWN SURGICAL DELAY. DOI: (B)(6) 2024, DOR: (B)(6) 2024, AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Joint Dislocation

  MAUDE report 20289836 ↗
• InjurySep 20, 2024Naturally Worn; Naturally Worn

  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 20270989 ↗
• MalfunctionJul 30, 2024Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT INTRAOPERATIVELY DURING PRIMARY SURGERY IT WAS NOT POSSIBLE TO ENGAGE THE INLAY WITH THE METAPHYSIS. ANOTHER INLAY WAS USED WITHOUT ISSUES. SURGICAL DELAY ABOUT TWO MINUTES. NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: Insufficient Information

  MAUDE report 19859812 ↗
• 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 19751373 ↗
• InjuryJun 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY NO DOTS CLINICAL ADVERSE EVENT RECEIVED FOR SUSPICION OF PROSTHETIC INFECTION - LEFT SHOULDER. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS NOT RELATED TO DEVICE OR PROCEDURE. DATE OF IMPLANT: (B)(6) 2024 DATE OF EVENT: (B)(6) 2024 (LEFT SHOULDER) TREATMENT: I&D NO REVISION COMPLETED.

  Patient problems: Unspecified Infection

  MAUDE report 19563239 ↗
• InjuryJun 14, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED FOR DISLOCATION. DOI: UNKNOWN DOR: (B)(6) 2024 AFFECTED SIDE : LEFT SHOULDER .

  Patient problems: Joint Dislocation

  MAUDE report 19537684 ↗
• InjuryMay 16, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT HAD PREVIOUS REVERSE SHOULDER ARTHROPLASTY ON FEB 13, 2024 AND HAS HAD SEVERAL DISLOCATIONS SINCE. PATIENT WAS BROUGHT BACK TODAY TO REMOVE THE POLY AND PUT IN A THICKER CONSTRUCT. DOI: (B)(6) 2024 DOR: (B)(6) 2024 AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Joint Dislocation

  MAUDE report 19331517 ↗
• InjuryMay 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD ORIGINAL SURGERY DONE (B)(6) 2022 AT HOSPITAL. UNFORTUNATELY THE BASEPLATE AND GLENOSPHERE COMPONENTS BECAME LOOSE. THE HUMERAL COMPONENTS WERE FOUND TO BE WELL FIXED AND STABLE. SURGEON FELT THE PATIENT WOULD BENEFIT FROM A THOROUGH WASHOUT OF THEIR SHOULDER AND A REVISION OF THEIR GLENOID COMPONENTS. ONCE IMPLANTS WERE REMOVED AND THE SHOULDER WAS WASHED, THE GLENOID WAS PREPPED FOR AN INHANCE BASEPLATE. A TRIAL REDUCTION WAS PERFORMED WITH A 40 +8 ECCENTRIC GLENOSPHERE AND A 42 +6R POLY ON THE DELTA HUMERAL SIDE. SURGEON WAS OK WITH THE MISMATCH OF GLENOSPHERE TO POLY DUE TO NOT WANTING TO REVISE THE WELL FIXED HUMERAL COMPONENT. THE SHOULDER WAS FOUND TO BE STABLE, SO FINAL IMPLANTS WERE OPENED AND INSERTED. STABILITY WAS CONFIRMED AND THE CLOSING PROCESS BEGAN. THERE WAS NO ADVERSE EVENTS OR DELAYS TOOK PLACE. DOI: (B)(6) 2022 DOR: (B)(6) 2024 AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Insufficient Information

  MAUDE report 19319433 ↗
• InjuryApr 19, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO DISLOCATED SHOULDER. DOI: (B)(6) 2022. DOR: (B)(6) 2024. AFFECTED SIDE: UNKNOWN.

  Patient problems: Joint Dislocation

  MAUDE report 19144121 ↗
• InjuryMar 25, 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 UNKNOWN REASON (B)(4). THE PATIENT HAD IRRIGATION AND DEBRIDEMENT (I&D) WITH POLY EXCHANGE DONE ON (B)(6) 2021. DOI: (B)(6) 2020. DOR: (B)(6) 2021. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Insufficient Information

  MAUDE report 18969396 ↗
• InjuryFeb 1, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT HAD POLY/GLENOSPHERE SWAP FOR DISLOCATION. NO OTHER INFORMATION KNOWN. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Joint Dislocation

  MAUDE report 18621488 ↗

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-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-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-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-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-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-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.