DELTA XTEND 130738206Recalls & reported problems

Summary

The FDA's MAUDE database contains 116 adverse event reports that list this exact device (DI 10603295027379), received between Jun 23, 2017 and Sep 28, 2026 — classified as 112 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (52 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 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 28, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unspecified Infection

  MAUDE report 50923063 ↗
• InjurySep 24, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that patient presented with a painful right shoulder. The surgeon revised the glenosphere and poly.Affected Side: Unknown Shoulder.

  Patient problems: Pain

  MAUDE report 50881944 ↗
• InjurySep 14, 2026Device Dislodged or Dislocated

  It was reported that the patient revised due to dislocation.DOI:(b)(6) 2020.DOR: (b)(6) 2026.Affected side: Left shoulder.

  Patient problems: Joint Dislocation

  MAUDE report 50752337 ↗
• InjurySep 1, 2026Device Dislodged or Dislocated

  It was reported that patient used arm too soon after last surgery and dislocated shoulder. The Surgeon chose to size up in implant sizing.DOI-(b)(6)2026DOR-(b)(6)2026Affected side-Right shoulder.

  Patient problems: Joint Dislocation

  MAUDE report 50550204 ↗
• InjuryApr 6, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE SHOULDER DISLOCATED FROM A PREVIOUS SURGERY. PUT IN A RETENTIVE POLY. DOI: UNKNOWN. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Joint Dislocation

  MAUDE report 24794127 ↗
• InjuryMar 3, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO JOINT INSTABILITY. THE POLYETHYLENE COMPONENT WAS EXCHANGED FOR A RETENTIVE LINER, AND THE REMOVED POLY WAS DISPOSED OF WITHOUT ISSUE. THERE WAS NO HARM TO THE PATIENT AND NO DELAY TO THE CASE. NO FURTHER INFORMATION. DOI: (B)(6) 2026, DOR: (B)(6) 2026, AFFECTED SIDE: LEFT.

  Patient problems: Joint Laxity

  MAUDE report 24496760 ↗
• InjuryJan 23, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO LOOSENING OF SHOULDER. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Joint Laxity

  MAUDE report 24161880 ↗
• 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) 16. 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 23597264 ↗
• 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 23513387 ↗
• InjuryJul 7, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WAS DISLOCATING, SO THE SURGEON DECIDED TO PUT IN A LARGER GLENOSPHERE, HUMERAL SPACER, AND A DIFFERENT POLYETHYLENE CUP. DOI: (B)(6) 2023. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Joint Dislocation

  MAUDE report 22412404 ↗
• InjuryMar 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT FELL AND NEEDED MORE LATERALIZED IMPLANTS FOR STABILITY. DOI: UNKNOWN. DOR: UNKNOWN. AFFECTED SIDE: UNKNOWN SHOULDER SIDE.

  Patient problems: Fall; Joint Laxity

  MAUDE report 21678324 ↗
• InjuryMar 24, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DISLOCATION RIGHT SHOULDER FOLLOWING IMPLANTATION OF REVERSE TOTAL SHOULDER. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Joint Dislocation

  MAUDE report 21678003 ↗
• InjuryFeb 6, 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 INCREASE TENSION IN SHOULDER. DOI: UNKNOWN. AFFECTED SIDE: UNKNOWN.

  Patient problems: Joint Laxity; Unspecified Tissue Injury

  MAUDE report 21322635 ↗
• InjuryDec 3, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT WAS BROUGHT BACK FOR DISLOCATION. DOI- (B)(6) 2024, DOR- (B)(6) 2024, AFFECTED SIDE- LEFT SHOULDER.

  Patient problems: Joint Dislocation

  MAUDE report 20832385 ↗
• InjuryNov 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD REVISED FOR INSTABILITY. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE- RIGHT SHOULDER.

  Patient problems: Joint Laxity

  MAUDE report 20747968 ↗
• InjuryOct 9, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ADDITIONAL INFORMATION RECEIVED THAT THERE WAS NO SURGICAL DELAY.

  Patient problems: Joint Dislocation

  MAUDE report 20406164 ↗
• InjuryJul 11, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO GLENOID WAS GROSSLY LOOSE. IMPLANT WAS PLACED HIGH ON THE GLENOID FACE. CEMENTED STEM. ENTIRE GLENOID CONSTRUCT WAS PULLED OUT WITH AND OSTEOTOME AND KOCHER. METAGLENE TWO LOCKING SCREWS AND 38 GLENOSPHERE. THE SUPERIOR LOCKING SCREW WAS BROKEN AND MOST OF IT WAS LEFT IN THE PATIENTS SUPERIOR GLENOID. POLY WAS REMOVED AS WELL AND HAD WEAR ON THE MEDIAL HALF OF THE RIM OF THE POLY. THEY DID NOT HAVE ANY IMPLANT RECORDS AND THE REF NUMBERS WERE NOT VISIBLE TO IDENTIFY SIZES AND LENGTHS. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Insufficient Information

  MAUDE report 19722248 ↗
• 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 19449371 ↗
• InjuryJun 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO INFECTED REVERSE TOTAL SHOULDER. ALL IMPLANTS WERE REMOVED AND A SPACER WAS IMPLANTED. THERE WAS NO LOOSENING. DOI: (B)(6) 2023. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Unspecified Infection

  MAUDE report 19446616 ↗
• InjuryMay 1, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT HAD REVISED REVERSE FOR DISLOCATION. PATIENT HAD A REVERSE FOR A FRACTURE AWHILE BACK. UNKNOWN SURGICAL DELAY. DOI: UNKNOWN DOR: (B)(6) 2024 AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Joint Dislocation

  MAUDE report 19222635 ↗
• 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 (B)(6) 2020 AND FIRST REVISION 2 MONTHS LATER FOR DISLOCATION.

  Patient problems: Joint Dislocation

  MAUDE report 18712458 ↗
• InjuryJan 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INSTABILITY. DOI: UNKNOWN, DOR: (B)(3) 2023, AFFECTED SIDE: UNKNOWN.

  Patient problems: Joint Laxity

  MAUDE report 18424882 ↗
• InjuryDec 1, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE LINER EXCHANGE WAS DONE. PATIENT EXPERIENCED DISLOCATION, SO THE PHYSICIAN ADDED A BIGGER POLY. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Joint Dislocation

  MAUDE report 18246298 ↗
• InjuryNov 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD BEEN UNSTABLE AND SEVERE KYPHOSIS EVIDENT WHICH COULD POTENTIALLY BE A CAUSE OF THE INSTABILITY. DOI: (B)(6) 2018. DOR: NOV 21, 2023. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Joint Laxity

  MAUDE report 18240446 ↗
• 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 18145786 ↗

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-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-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-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-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-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-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.