DELTA XTEND 130720203Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 10603295027331), received between Mar 6, 2019 and Sep 16, 2026 — classified as 19 injuries, 1 malfunction.

The most frequently reported specific device problem is “Contamination /Decontamination Problem” (1 report).

2 other recalls cover devices cleared under the same FDA submission (K071379, K120174, K192448, 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• InjurySep 16, 2026Adverse Event Without Identified Device or Use Problem

  It was reported revision surgery of a Right side Delta XTend reverse shoulder occurred due to pain.DOI: (b)(6) 2014.DOE: (b)(6) 2026.

  Patient problems: Pain

  MAUDE report 50787327 ↗
• InjuryDec 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INSTABILITY. DOI: (B)(6) 2022, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Joint Laxity

  MAUDE report 23790866 ↗
• InjuryNov 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT THE REVISION OF REVERSE LEFT SHOULDER DUE TO INFECTION. THIS REPORT IS RELATED COMPLAINT (B)(4), WHICH CAPTURES ADDITIONAL IMPACTED PRODUCTS.

  Patient problems: Unspecified Infection

  MAUDE report 23569944 ↗
• InjuryNov 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT THE REMOVAL OF DELTA XTEND SHOULDER DUE TO PAIN AND SUSPECTED INFECTION. SURGEON REQUESTED THE POSITION OF THE GLENOSPHERE AND THAT THE PATIENT WAS 'NOTCHING'. THERE WAS ALSO A FRACTURED ACROMIUM. THIS SUGGESTED THE DELTOID WAS UNDER SEVERE TENSION WHEN IMPLANT INSERTED. THE DELTA XTEND WAS REMOVED AND A DJO ALTIVATE REVERSE SHOULDER WAS IMPLANTED.

  Patient problems: Pain; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 23560209 ↗
• InjuryMay 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6) FIRST REPORT OF RETRIEVALS FOR STATEMENT OF WORK 10 FOR Q1 OF 2025. (B)(6) IS THE RESEARCH LOCATION, AND NOT THE FACILITY OF PLACEMENT. A DEPUY SYNTHES IMPLANT WAS REVISED AND REVIEWED FOR ANALYSIS. REASON FOR REVISION: REVISION DUE TO INFECTION AND GLENOID LOOSENING. AT REMOVAL THE HUMERAL CUP SHOWED MINOR YELLOWING.

  Patient problems: Unspecified Infection

  MAUDE report 21983815 ↗
• 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 19203083 ↗
• InjuryApr 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6); STUDY NO: (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR PERIPROSTHETIC INFECTION. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS NOT RELATED TO DEVICE OR PROCEDURE. DATE OF IMPLANT: (B)(6) 2023, DATE OF EVENT: (B)(6) 2024, (RIGHT SHOULDER). TREATMENT: I&D AND INJECTED MEDICATION.

  Patient problems: Unspecified Infection

  MAUDE report 19193415 ↗
• InjuryJul 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO CHRONIC INFECTION. ALL COMPONENTS REMOVED. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2010. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Unspecified Infection

  MAUDE report 17324351 ↗
• InjuryJun 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. DOI: UNKNOWN. DOR: (B)(6) 2022, AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Unspecified Infection

  MAUDE report 14829307 ↗
• InjuryMay 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. DOI: (B)(6) 2019. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Unspecified Infection

  MAUDE report 14470116 ↗
• InjuryJul 12, 2021Off-Label Use; Adverse Event Without Identified Device or Use Problem; Off-Label Use; Adverse Event Without Identified Device or Use Problem

  NO INSTRUMENTATION BROKE. SURGEON PURPOSELY USED A RIGHT IN A LEFT SHOULDER DUE TO UNIQUE ANATOMY. IT WAS ASSUMING LOOSENING WAS CAUSED BY INFECTION.

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

  MAUDE report 12152661 ↗
• InjuryApr 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION ORIGINAL IMPLANT DATE IS UNKNOWN. DOI: UNKNOWN DOR: (B)(6) 2021 UNKNOWN SHOULDER SIDE.

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

  MAUDE report 11632082 ↗
• InjuryMar 31, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION OF SHOULDER REPLACEMENT - REMOVAL OF ALL IMPLANTS, ANTIBIOTIC SPACER IMPLANTED. RIGHT SHOULDER.

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

  MAUDE report 11599028 ↗
• InjuryMar 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ORIGINAL PRIMARY OPERATION WAS IN (B)(6) 2013. PATIENT BECAME UNWELL AND THERE WAS A SUSPICION OF INFECTION. THE SHOULDER HAD PREVIOUS WASHOUTS WITH NO REAL BENEFIT. ALL IMPLANTS WERE REMOVED AND A TEMPORARY CEMENTED SPACER WAS IMPLANTED.

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

  MAUDE report 11486257 ↗
• InjuryOct 19, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO TENDON REPAIR. CHANGED EPIPHYSIS AND POLY WAS DONE. DOI: UNKNOWN DOR: (B)(6) 2020 RIGHT SHOULDER.

  Patient problems: No Code Available

  MAUDE report 10699761 ↗
• InjuryMay 6, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ALL ITEMS WERE REMOVED FROM A REVERSE SHOULDER THAT WAS INFECTED. DOI: (B)(6) 2019 (HUMERAL CUP). DOR: (B)(6) 2020; UNK AFFECTED SIDE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10029802 ↗
• InjuryApr 1, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REASON FOR REVISION: PAIN DUE TO POSSIBLE INFECTION. THE SURGEON HAD PRIOR CONCERNS WITH REGARDS THE PATIENTS SKIN CONDITION (LETTER AVAILABLE). THE PATIENT HAS SUBSEQUENT TO PRIMARY SURGERY PRESENTED WITH PAIN IN THE SHOULDER. THE SURGEON HAS TREATED THE PATIENT CONSERVATIVELY TO ADDRESS POSSIBLE INFECTION. CONSERVATIVE TREATMENT HAS NOT ADDRESSED THE PROBLEM AND THE SURGEON HAS TAKEN THE DECISION TO CARRY OUT A TWO STAGE REVISION, REMOVE ALL COMPONENTS AND TEMPORARILY REPLACE WITH A CEMENT SPACER. SURGEON WILL ADVISE ON WHEN THE PATIENT WILL BE BROUGHT BACK FOR SURGERY.

  Patient problems: No Code Available; Pain; Unspecified Infection

  MAUDE report 9910501 ↗
• MalfunctionAug 27, 2019Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT THE SURGEON DID A DELTA REVERSE SHOULDER ON THE PATIENT. WHEN IT CAME TIME TO OPEN THE IMPLANTS, THEY NOTICED THE 130720203/5302855 BOX HAD WRINKLES IN THE CORNER OF THE BOX. THE BOX WAS OPENED AND THE NURSE NOTICED THE SEAL LOOKED COMPROMISED ON THE INNER PACKAGE. THEY IMMEDIATELY REMOVED THE IMPLANT FROM THE OR AND REPLACED WITH ANOTHER IMPLANT. NO DELAY OCCURRED. THE IMPLANT WILL BE RETURNED FOR INSPECTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8934816 ↗
• InjuryAug 20, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PRIMARY SURGERY: APPROX 6 YEARS AGO -THE REASON FOR THE REVISION SURGERY WAS BECAUSE THE PATIENT HAD BEEN NOTCHING WHICH HAD CAUSED THE GLENOSPHERE IMPLANTS TO DISENGAGE FROM THE BONE. IN THE PROCESS, ONE OF THE LOCKING SCREWS WAS BROKEN. UPON EXPOSURE TO THE JOINT, IT WAS CLEAR THAT THE PATIENT ALSO HAS AN INFECTION. THE STEM WAS LEFT IN AS IT WAS SOUND, BUT THE IMPLANTS BELOW WERE REMOVED. THIS ALSO INCLUDED 4 SCREWS, NOT SURE EXACTLY WHAT WAS USED. 2X LOCKING AND 2X NON-LOCKING SCREWS WERE USED. THE SITE WAS THOROUGHLY WASHED, AND THEN A CTA HEAD WAS IMPLANTED TO PERFORM A HEMI-ARTHROPLASTY.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8910792 ↗
• InjuryMar 6, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8394472 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K071379, K120174, K192448, 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