DELTA XTEND 130712100Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295027188), received between Oct 8, 2019 and Feb 14, 2024 — classified as 3 injuries.

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. 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REMOVAL OF ALL DELTA XTEND IMPLANTS DUE TO INFECTION. SURGEON DID ORIGINAL OPERATION IN 2020 AND FIRST REVISION 2 MONTHS LATER FOR DISLOCATION. NO SURGICAL DELAY.

  Patient problems: Unspecified Infection

  MAUDE report 18702713 ↗
• InjuryJun 8, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AFFECTED SIDE IS THE LEFT.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10130045 ↗
• InjuryOct 8, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION REVERSE TOTAL SHOULDER: (B)(6) HOSPITAL, (B)(6) 2019. THIS WAS THE 2ND REVISION ON THIS PATIENT DUE TO CHRONIC DISLOCATION. PRIMARY IMPLANT DONE IN 2017 AND FIRST REVISION IN MID-2018. ORIGINAL CASE WAS A FRACTURED HUMERUS, AND THE FIRST REVISION WAS DONE DUE TO DISLOCATION. THE PATIENT ENDED UP AFTER FIRST REVISION WITH SPACER PLUS 38/9 POLY. THE SURGEON SAID PATIENT HAD FALLEN AGAIN AND REQUIRED RE REVISION. THE ORIGINAL PLAN WAS TO CONVERT TO HEMI WITH A CTA HEAD AS HE THOUGHT THE GLENOID COMPONENTS WOULD BE LOOSE, BUT AFTER OPENING THE BASE PLATE WAS SECURE SO HE UPSIZED THE HEAD TO A 42 AND PUT IN A 6 STANDARD POLY AND IT WASN'T DISLOCATING AT ALL. THE SURGEON SAID REVISION HAD NOTHING TO DO WITH THE IMPLANT, HE FELT THE PATIENT HAD DELTOID INSUFFICIENCY AND HAD SEVERE INFECTION ISSUES FOR MANY YEARS. FEMALE PATIENT, INITIAL: R., DOB:(B)(6) 1950.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9166370 ↗

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-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-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-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-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-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-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.