DELTA XTEND 130770024Recalls & reported problems

Summary

The FDA's MAUDE database contains 36 adverse event reports that list this exact device (DI 10603295027799), received between Sep 14, 2017 and Sep 17, 2026 — classified as 32 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Osseointegration Problem” (9 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. 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 36 reports, in the reporter's own words as published by the FDA.

• InjurySep 17, 2026Osseointegration Problem

  Patient problems: Inadequate Osseointegration; Unspecified Infection

  MAUDE report 50810872 ↗
• InjuryJul 27, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that on 22-May-2024 the patient had a Primary Delta Xtend Reverse. On (b)(6) 2024 patient had their implants removed due to infection and pain and a spacer was placed for treatment of infection. On (b)(6) 2024 the patient had their first spacer removed and a second spacer placed for continued treatment of infection. On (b)(6) 2025 the second spacer was removed and final implants were placed.This complaint is related to (b)(4) which captures reported additional events.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 50004011 ↗
• InjuryJun 10, 2026Osseointegration Problem

  IT WAS REPORTED THAT REVISION OF LEFT REVERSE TOTAL SHOULDER DUE TO LOOSE METAGLENE. ORIGINAL DOS (B)(6) 2023. DOI: (B)(6) 2023, DOR: (B)(6) 2026, AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Inadequate Osseointegration

  MAUDE report 25456597 ↗
• InjuryApr 30, 2026Fracture

  IT WAS REPORTED THAT THE METAGLEEN FAILED AND BROKE THREE SCREWS. THIS WAS THE SECOND REVISION FOR THIS PATIENT WHO ORIGINALLY HAD BONE GRAFT DONE. THE DOCTOR CONVERTED THIS TO A HEMI. AFFECTED SIDE- RIGHT SHOULDER.

  Patient problems: Insufficient Information

  MAUDE report 25042868 ↗
• InjuryApr 14, 2026Osseointegration Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO GLENOID BASEPLATE1 LOOSENING. LOOSENING INTERFACE WAS MARKED AS BONE TO IMPLANT. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Inadequate Osseointegration

  MAUDE report 24873325 ↗
• InjuryApr 14, 2026Osseointegration Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO GLENOID BASEPLATE1 LOOSENING. LOOSENING INTERFACE WAS MARKED AS BONE TO IMPLANT. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Inadequate Osseointegration

  MAUDE report 24873324 ↗
• InjuryNov 13, 2025Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE DELTA EXTEND BASE PLATE CAME LOOSE. THE ORIGINAL SURGERY WAS DONE WITH GRAFT BEHIND THE GLENOSPHERE. THE DOCTOR NOTED THAT THE BONE DIDN'T INTERFERE THAT WELL AND WAS LIKELY THE REASON FOR FAILURE. THE DOCTOR REMOVED THE BASE PLATE AND POLY; IT WAS REPLACED WITH A CTA HEMI HEAD. DOI: UNKNOWN. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Inadequate Osseointegration

  MAUDE report 23542675 ↗
• InjuryNov 12, 2025Osseointegration Problem; Osseointegration Problem

  PATIENT WAS REVISED DUE TO BASEPLATE CAME LOOSE. DOCTOR DID THE ORIGINAL CASE WITH BONE GRAFT BEHIND THE METAGLEEN AND IF FAILED. HE REVISED IT TO A CTA HEMI AND REMOVED THE BASE PLATE AND POLY. DOI: (B)(6) 2022, DOR: UNKNOWN, AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Inadequate Osseointegration

  MAUDE report 23532388 ↗
• 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 23488244 ↗
• MalfunctionOct 28, 2025No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED A LEFT SHOULDER REVISION OCCURRED (B)(6) 2025, DUE TO POST TRAUMATIC ACUTE GLENOID LOOSENING. THE SURGEON BELIEVES IT IS AN UNDOCUMENTED FALL. PRIMARY SURGERY DATE (B)(6) 2018.

  Patient problems: Insufficient Information

  MAUDE report 23405111 ↗
• InjuryOct 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL CASE IN REGARDS TO (B)(4) TO CAPTURE THE PREVIOUS PARTIAL REVISION. PARTIAL REVISION PROCEDURE: REMOVAL OF ALL COMPONENTS EXCEPT THE STEM RETAINED COMPONENT: STEM. NEW COMPONENTS INSERTED: EPI BODY, CTA HEAD. INDICATION: SUSPECTED INFECTION. STEM WAS WELL-FIXED AND COULD NOT BE REMOVED. CTA HEAD PLACED ONTO RETAINED STEM. PURULENT FLUID OBSERVED IN BONE AND ON IMPLANTS. SWABS TAKEN FOR MICROBIOLOGICAL TESTING. PATIENT COMMENCED ON HIGH-DOSE ANTIBIOTICS.

  Patient problems: Unspecified Infection

  MAUDE report 23372464 ↗
• InjuryJun 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S SHOULDER BECAME INFECTED AND HARDWARE NEEDED TO BE REMOVED. DOI: (B)(6) 2022. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Unspecified Infection

  MAUDE report 22161128 ↗
• MalfunctionMay 29, 2025Fracture; Fracture

  ADDITIONAL INFORMATION WAS RECEIVED: A: WAS THERE ANY SPECIFIC ALLEGATION AGAINST THE METAGLENE? NO. B: COULD YOU PLEASE PROVIDE THE AFFECTED SIDE? LEFT.

  Patient problems: Foreign Body In Patient

  MAUDE report 22104878 ↗
• InjuryJan 9, 2025Osseointegration Problem; Osseointegration Problem

  PATIENT WAS REVISED AS THE GLENOID IMPLANT WAS LOOSE. IT WAS AN UNKNOWN EVENT AND ALL IMPLANTS WERE REMOVED. SURGICAL DELAY WAS UNKNOWN. AFFECTED SIDE: UNKNOWN SHOULDER.

  Patient problems: Inadequate Osseointegration

  MAUDE report 21114248 ↗
• InjuryDec 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ALL IMPLANTS WERE REMOVED DUE TO INFECTION. DOI: (B)(6) 2022; DOR: (B)(6) 2024; AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Unspecified Infection

  MAUDE report 20848792 ↗
• InjuryMay 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. EVERYTHING WAS EXPLANTED AND A SPACED WAS PUT IN. DOI: (B)(6) 2023; DOR:(B)(6) 2024; AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 19384322 ↗
• InjuryApr 29, 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 INFECTION. 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 (RIGHT SHOULDER) TREATMENT: INJECTED MEDICATION.

  Patient problems: Unspecified Infection

  MAUDE report 19203205 ↗
• InjuryApr 29, 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 INFECTION. 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 (RIGHT SHOULDER) TREATMENT: INJECTED MEDICATION.

  Patient problems: Unspecified Infection

  MAUDE report 19203183 ↗
• InjuryMar 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  EXPANSION OF PROTHESIS BECAUSE OF INFECTION. PATIENT IS STRONG SMOKER. PROCEDURE SUCCESSFULLY COMPLETED WITH NO DELAY.

  Patient problems: Unspecified Infection

  MAUDE report 18912810 ↗
• InjuryAug 3, 2023Osseointegration Problem; Osseointegration 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: Inadequate Osseointegration; Pain; Unspecified Infection

  MAUDE report 17450255 ↗
• InjuryJul 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE INITIAL SURGERY ON (B)(6) CONVERTED A UNITE ANATOMIC TSA TO A REVERSE TSA. THE PATIENT BECAME UNSTABLE AND DISLOCATED IN LAST FEW WEEKS. DURING REVISION IT WAS DISCOVERED THE EPI WAS NOT COMPLETELY LOCKED DOWN AND HAD ROTATED. SURGEON REMOVED ALL DEPUY COMPONENTS AND WENT BACK WITH ARTHREX WHICH HE USES REGULARLY. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Joint Laxity

  MAUDE report 17343773 ↗
• MalfunctionOct 31, 2022Fracture; Fracture

  IT WAS REPORTED THAT THE NON-LOCKING METAGLENE SCREW SNAPPED IN HALF WHEN THE SURGEON WAS TIGHTENING. HALF THE SCREW REMAINS IN THE GLENOID. THE SURGEON DIDN¿T SEEM TO BE EXERTING UNUSUAL FORCE WHEN TIGHTENING. THERE WAS NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15699810 ↗
• InjuryOct 12, 2021Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available

  MEDICAL RECORDS RECEIVED. THE PATIENT IN THE YEAR 2018 HAD SURGERY FOR THE REMOVAL OF SYNOVIAL CYSTS IN THE RIGHT SHOULDER REVERSE PROSTHESIS. THE PATIENT IN THE YEAR 2019 (B)(6)2019 HAS A REVISION SURGERY DUE TO METALLOSIS TO REMOVE THE IMPLANT AND REVERSE ARTHROPROSTHESIS AND BONE GRAFT. COMPETITOR PRODUCTS WERE USED IN THE REVISION AS REPLACEMENTS.

  Patient problems: Foreign Body Reaction; Pain

  MAUDE report 12619042 ↗
• InjuryJul 23, 2021Osseointegration Problem; Osseointegration Problem

  THE PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE METAGLENE/ GLENOSPHERE AT THE IMPLANT TO BONE INTERFACE. IT REPORTED THAT THE GLENOSPHERE DID NOT APPEAR TO BE TIGHTENED LOCKED DOWN ALL THE WAY. BONE LOSS AROUND THE METAGLENE APPEARED TO CONTRIBUTE TO LOOSENING OF THAT COMPONENT. THE REPORTED IMPLANT WAS A NON-CEMENTED. ORIGINAL IMPLANT DATE WAS UNKNOWN. NO SURGICAL DELAY. DOI: UNKNOWN, DOR: (B)(6) 2021, RIGHT SHOULDER.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Inadequate Osseointegration

  MAUDE report 12219930 ↗
• InjuryJul 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD REMOVAL OF DELTA XTEND PROSTHESIS DUE TO INFECTION. ORIGINAL IMPLANTATION DONE BACK IN 2013. DOS: (B)(6) 2013.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12143108 ↗

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-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-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-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.
• 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-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-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-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.