DELTA XTEND 130760138Recalls & reported problems

Summary

The FDA's MAUDE database contains 146 adverse event reports that list this exact device (DI 10603295027768), received between Jun 23, 2017 and Jun 9, 2026 — classified as 122 injuries, 24 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (73 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 146 reports, in the reporter's own words as published by the FDA.

• InjuryJun 9, 2026Device Dislodged or Dislocated

  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 25445311 ↗
• InjuryApr 8, 2026Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT DXTEND GLENOSPHERE STD D38MM WAS INCORRECTLY IMPLANTED INTO A CSM BASEPLATE DURING AN ARTHROPLASTY PROCEDURE. THE EVENT INVOLVED THE SELECTION OF THE WRONG GLENOSPHERE, WHICH IS NOT RECOMMENDED FOR USE WITH THE METAGLENE IN QUESTION, CREATING A RISK OF DISENGAGEMENT AND POTENTIAL IMPLANT FAILURE. THE PROCEDURE WAS NOT SUCCESSFULLY COMPLETED, AND THE PATIENT FACED A POTENTIAL RISK OF REVISION SURGERY DUE TO THE IMPROPER IMPLANT SELECTION. THE IMPLANT WAS LEFT IN SITU.

  Patient problems: Insufficient Information

  MAUDE report 24814813 ↗
• InjuryFeb 17, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO UNSTABLE SHOULDER. NO ADDITIONAL INFORMATION IS AVAILABLE AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Joint Laxity

  MAUDE report 24364797 ↗
• 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 24223645 ↗
• InjuryJan 20, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A REVISION SURGERY AND REMOVAL OF IMPLANTS FROM DELTA EXTEND OCCURRED ON (B)(6) 2026 DUE TO INFECTION. REMOVAL OF GLENNOSPHERE AND LINER WITH A WASH OUT WITH SALINE AND BACTISURE. IMPLANTED WITH NEW HARDWARE.

  Patient problems: Unspecified Infection

  MAUDE report 24120245 ↗
• InjuryNov 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS RETURNED TO SURGERY ON (B)(6) 2025, TO REMOVE BONE SPURS. ORIGINAL SURGERY WAS ON (B)(6) 2016. THERE WAS NO LOOSENING, NO ISSUES OR CONCERNS WITH IMPLANTS. THE POLY AND GLENOSPHERE WERE EXCHANGED TO GET ACCESS TO REMOVE BONE SPUR. DOI: (B)(6) 2016. DOR: (B)(6) 2025. AFFECTED SIDE: UNKNOWN.

  Patient problems: Bone Notching

  MAUDE report 23597261 ↗
• InjuryNov 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT NEEDED MORE STABILITY. DR. SWAPPED GEOSPHERES FOR 42+2 AND ADDED +9 SPACER WITH 42+6 RETENTIVE LINER. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Joint Laxity

  MAUDE report 23513360 ↗
• 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 22462426 ↗
• InjuryFeb 6, 2025Fracture; No Apparent Adverse Event; Fracture; No Apparent Adverse Event

  DOI: (B)(6) 2019. DOR: (B)(6) 2024. PATIENT PRESENTED WITH PAIN AND CT SCAN SHOWED BROKEN CENTRAL SCREW OF GLENOSPHERE. PATIENT WAS REVISED.

  Patient problems: Pain

  MAUDE report 21323381 ↗
• InjuryFeb 3, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A PRIMARY SHOULDER OPERATION, AND WAS REOPERATED DUE TO LUXATION WHEN THE GLENOSPHERE WAS NOT CHANGED. POST-OPERATIVE INFECTION WAS TREATED WITH ANTIBIOTICS. SEARCHED FOR PAIN ON A CT SCAN IT WAS SUSPECTED THAT THE CENTER SCREW IN THE GLENOSPHERE HAD BROKEN. PATIENT WAS RE-OPERATED ON, AND IT WAS THEN FOUND THAT THE SCREW WAS OFF.

  Patient problems: Insufficient Information; Joint Laxity; Pain; Unspecified Infection

  MAUDE report 21292465 ↗
• InjuryJan 6, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT SHOULDER WAS REVISED DUE TO FRACTURE/DISLOCATION. DOI: (B)(6) 2017. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Joint Dislocation

  MAUDE report 21085627 ↗
• InjuryAug 13, 2024Fracture; Device Dislodged or Dislocated; Fracture; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THIS WAS AN RSA FOR CTA PERFORMED ON UNKNOWN DATE. UNKNOWN DEFECT OCCURRED. WE ARE CONFIRMING ABOUT DETAILS. THE SURGEON SPECULATED THAT THE GLENOSPHERE WAS NOT PROPERLY INSTALLED. THERE WAS NO SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE. ADDITIONAL EVENT INFORMATION: IT WAS REPORTED THAT THIS WAS RSA PERFORMED ON (B)(6) 2022, WITH THE IMPLANT IN QUESTION. LESS THAN TWO YEARS AFTER THE SURGERY, THE IMPLANT IN QUESTION WAS DISLODGED AND FRACTURED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 19972473 ↗
• InjuryAug 6, 2024Fracture; Fracture

  IT WAS REPORTED THAT GLENOSPHERE WAS DEFECTIVE. DOE: (B)(6) 2024. AFFECTED SIDE: LEFT SHOULDER. ADDITIONAL EVENT INFORMATION: A. NO DELAY. B. NO ADVERSE CONSEQUENCES. C. THE MAN HOLE. COVER CAME OFF THE BACK OF THE GLENOSPHERE AND THE SECURITY SCREW BROKE. D. DIDN'T HAPPEN DURING SURGERY.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19916737 ↗
• InjuryAug 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT MORE LATERALIZATION WAS NEEDED. DOI: (B)(6) 2019. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Joint Laxity

  MAUDE report 19907073 ↗
• InjuryJun 7, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT HAS PAIN IN RIGHT SHOULDER AND X-RAY SHOWS LOOSE GLENOID COMPONENT. DOI: (B)(6)2008 DOE: (B)(6)2024 AFFECTED SIDE: UNKNOWN

  Patient problems: Joint Dislocation; Pain

  MAUDE report 19487211 ↗
• InjuryJun 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD INITIAL SURGERY DONE (B)(6) 2016 AT THE HOSPITAL BY THE SURGEON. THE PATIENT'S SHOULDER WAS INFECTED, AND THE SURGEON FELT THE PATIENT WOULD BENEFIT FROM SINGLE STAGE WASHOUT. EPI, POLY, AND GLENOSPHERE WERE REMOVED. THE SHOULDER WAS WASHED OUT AND NEW COMPONENTS WERE IMPLANTED. STABILITY WAS CONFIRMED AND NO DELAYS OR ADVERSE EVENTS TOOK PLACE. DOI: (B)(6) 2016. DOR: (B)(6) 2024 . AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Unspecified Infection

  MAUDE report 19449369 ↗
• InjuryMay 13, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT HAS CATOSTROPHOC FAILURE. PUT A NEW GLENOSPHERE IN AND A SPACER. THIS IS A PATIENT WHO HAS BEEN REVISED MULTIPLE TIMES. DOI: (B)(6) 2015. DOR: (B)(6) 2024. AFFECTED SIDE : RIGHT SHOULDER .

  Patient problems: Joint Dislocation; Pain; Unspecified Infection

  MAUDE report 19304714 ↗
• InjuryApr 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INSTABILITY. UNKNOWN SURGICAL DELAY. DOI: (B)(6) 2019. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Joint Laxity

  MAUDE report 19214716 ↗
• InjuryMar 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REASON FOR PRIMARY SURGERY FRACTURED HUMERUS. REVISION OF DELTA DUE TO INFECTION SITE LEFT SHOULDER.

  Patient problems: Unspecified Infection

  MAUDE report 18895454 ↗
• InjuryFeb 15, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THIS CASE LOGGED TO CAPTURE THE PREVIOUS REVISION MENTIONED IN (B)(4). SURGEON DID ORIGINAL OPERATION IN (B)(6) 2020 AND FIRST REVISION 2 MONTHS LATER FOR DISLOCATION.

  Patient problems: Joint Dislocation

  MAUDE report 18712460 ↗
• InjuryNov 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD A RSA FOR A PROXIMAL HUMERAL FRACTURE ON (B)(6) 2023. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. AFTER SURGERY, INFECTION WAS CONFIRMED. A REMOVAL SURGERY WILL BE PERFORMED AS SOON AS A PREPARATION IS READY. DOI: (B)(6) 2023. RIGHT SHOULDER.

  Patient problems: Unspecified Infection

  MAUDE report 18145780 ↗
• InjuryOct 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD THE RIGHT SHOULDER REPLACED FIVE YEARS AGO WHERE THEY RECEIVED A DELTA EXTEND REVERSE SHOULDER CONSTRUCT. PATIENT RECENTLY CAME TO DOCTOR BECAUSE OF RIGHT SHOULDER PAIN, X-RAYS REVEALED THAT COULD BE A STEEL LYSIS. IT¿S SEVERE BONE LOSS AROUND THE IMPLANTS. DOCTOR REVISE THE SHOULDER, EXPLANTED AND METAGLENE COMPONENT, GLENOSPHERE, FOUR SCREWS, AND THE PROXIMAL BODY. THE LOT NUMBERS FOR THE HUMERAL CUP AND THE FOUR SCREWS WERE ILLEGIBLE. THE HUMERUS STEM WAS LEFT IN SITU, AND A NEW PROXIMAL BODY WAS PUT ON. BECAUSE OF THE SEVERE BONE LOSS IN THE GLENOID, A CTA HEAD WAS UTILIZED. DOI: UNKNOWN, DOR: (B)(6) 2023, AFFECTED SIDE: RIGHT SHOULD.

  Patient problems: Pain; Unspecified Tissue Injury

  MAUDE report 17953432 ↗
• InjuryAug 14, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  REVISION OF RIGHT REVERSE SHOULDER REPLACEMENT: PRIMARY SURGERY COMPLETED. PATIENT BECAME CONFUSED OVERNIGHT, TOOK OFF SLING AND TRIED TO GET UP, DISLOCATING SHOULDER. SURGEON ATTEMPTED CLOSED REDUCTION BUT COULD FEEL SHOULDER WOULD CONTINUE TO POP OUT. SUSPECTED A THICKER POLY COULD BE USED FOR MORE SOFT TISSUE TENSION AND BONEY IMPINGEMENT. ON X-RAY SOME INFERIOR BONE COULD BE SEEN THAT WAS NOT REMOVED BY SURGEON, POTENTIALLY CAUSING THE SHOULDER TO IMPINGE AND DISLOCATE. WENT BACK IN, REMOVED THE BONE, SWITCHED TO A LARGER AND ECCENTRIC GLENSOPHERE TO PROVIDE MORE INFERIOR OFFSET AND A THICKER POLY. SHOULDER WAS NO LONGER DISLOCATING. DOI: (B)(6) 2023. DOE: (B)(6) 2023. AFFECTED SIDE: RIGHT.

  Patient problems: Joint Dislocation; Joint Laxity; Unspecified Mental, Emotional or Behavioral Problem

  MAUDE report 17540514 ↗
• InjuryAug 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO LOOSENING OF METAGLENE AND GLENOSPHERE. SCREWS WERE ALSO BROKEN. PATIENT ALSO EXPERIENCED PAIN AND POSSIBLE INFECTION. THERE WAS NO SURGICAL DELAY. DOI- (B)(6) 2012. DOR- (B)(6) 2023. AFFECTED SIDE- RIGHT SHOULDER.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 17450258 ↗
• InjuryJul 12, 2023Noise, Audible; Noise, Audible

  DEVICE REPORT FROM DEPUY SYNTHES AUSTRALIA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT PATIENT UNDERWENT A RIGHT SHOULDER REVISION ON (B)(6)2023, DUE TO A CLICKING SOUND AND INCREASING PAIN WHICH HAS BECOME SIGNIFICANT DURING THE LAST FEW MONTHS. THIS REPORT IS FOR DXTEND GLENOSPHERE STD D38MM. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: Pain; Unspecified Tissue Injury

  MAUDE report 17306328 ↗

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-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-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-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-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-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-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.