DELTA XTEND 130742106Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10603295027522), received between Sep 27, 2019 and Sep 21, 2026 — classified as 12 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (5 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjurySep 21, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient was revised due to unstable shoulder.Affected side: Right shoulder.

  Patient problems: Joint Laxity

  MAUDE report 50840190 ↗
• MalfunctionSep 8, 2026Difficult to Insert

  Patient problems: Insufficient Information

  MAUDE report 50675461 ↗
• InjuryJun 8, 2026Naturally Worn

  IT WAS REPORTED THAT PATIENT HAS HAD MULTIPLE FALLS AND THE GLENOSPHERE DISASSOCIATED FROM THE BASE PLATE. POLY WAS DEFORMED FROM RUBBING AGAINST BASEPLATE. DOCTOR DECIDED THAT A CTA HEAD WOULD BE THE BEST CHOICE FOR THIS PATIENT. TOOK OUT POLY, GLENOSPHERE, BASEPLATE, AND SCREWS AND REPLACED WITH THE CTA HEAD. IT WAS STATED THAT THE LOOSENING OF SHOULDER GLENOSPHERE WAS UNKNOWN. DOI: UNKNOWN, DOR: (B)(6) 2026, AFFECTED SIDE: UNKNOWN.

  Patient problems: Unspecified Musculoskeletal problem

  MAUDE report 25433361 ↗
• InjuryApr 7, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT WAS LIFTING A TRAILER HITCH AND THEIR REVERSE SHOULDER DISLOCATED. THE POLY WAS SWAPPED AFTER CHECKING THE VERSION. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Joint Dislocation

  MAUDE report 24799929 ↗
• InjuryMar 3, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SHOULDER REVISED FOR BASEPLATE LOOSENING DUE TO INFECTION. 48MM ANTIBIOTIC SPACER IMPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 24494238 ↗
• InjuryJul 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD HIS RIGHT SHOULDER REPLACED BY THE PRIMARY SURGEON ON (B)(6) 2022 WHERE HE RECEIVED A DELTA EXTEND REVERSE SHOULDER CONSTRUCT. HE CAME TO THE REVISING SURGEON EARLIER THIS YEAR WITH SHOULDER PAIN WHERE THE SURGEON REVISED THE CONSTRUCT BECAUSE OF A LOOSE BASEPLATE. UNFORTUNATELY, THE PATIENT SHOULDER BECAME INFECTED FOLLOWING THE REVISION. THE REVISING SURGEON THEN REVISED THE SHOULDER AND EXPLANTED ALL OF THE COMPONENTS AND IMPLANTED A ANTIBIOTIC SPACER. SURGICAL DELAY WAS UNKNOWN. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Unspecified Infection

  MAUDE report 19710866 ↗
• InjuryNov 14, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  REVISION COMPLETED DUE TO DISLOCATION. THERE WAS NO SURGICAL DELAY. DOI:(B)(6). DOR: (B)(6). AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Joint Dislocation

  MAUDE report 15793306 ↗
• InjuryJul 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INSTABILITY. DOI: (B)(6) 2018, DOR: (B)(6) 2020, RIGHT SHOULDER.

  Patient problems: No Code Available

  MAUDE report 10251239 ↗
• InjuryJun 17, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT WAS REVISED TO ADDRESS DISLOCATION. NO SURGICAL DELAY NOTED. DOI: (B)(6) 2020, DOR: (B)(6) 2020, RIGHT SHOULDER.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 10166028 ↗
• InjuryApr 16, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO SCAPULAR NOTCHING. REVISED TO AN OFFSET GLENOSPHERE. NO SURGICAL DELAY. DOI: (B)(6) 2019; DOR: (B)(6) 2020; LEFT SIDE.

  Patient problems: No Code Available

  MAUDE report 9969898 ↗
• InjuryApr 13, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT WAS REVISED TO ADDRESS DISLOCATION. DOI: (B)(6) 2019. DOR: (B)(6) 2020; RIGHT SHOULDER.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 9954256 ↗
• InjuryMar 16, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SURGEON IS REQUESTING FOR MORE OFFSET DUE TO SCAPULAR NOTCHING. DOI: (B)(6) 2019; DOR: UNK; LEFT SHOULDER.

  Patient problems: Injury; No Code Available

  MAUDE report 9834884 ↗
• InjurySep 27, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT WAS REVISED TO ADDRESS DISLOCATION AND LOOSENING OF THE HUMERAL STEM AT THE BONE TO IMPLANT INTERFACE. DOI: (B)(6) 2017. DOR: (B)(6) 2019. RIGHT SHOULDER.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 9131275 ↗

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-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-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-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.
• 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-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-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-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.