DELTA XTEND 130714000Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10603295027225), received between May 6, 2020 and Nov 21, 2024 — classified as 14 injuries.

The most frequently reported specific device problem is “Off-Label Use” (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. 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryNov 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENTS LEFT SHOULDER IS BEING REVISED DUE TO INSTABILITY. DOI: (B)(6), 2021 DOR: (B)(6) 2024 AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Joint Laxity

  MAUDE report 20752444 ↗
• InjuryOct 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT A PRIOR REVERSE DELTA XTEND AND NOW EXPERIENCING A BRACHIAL PLEXUS NEUROPATHY AND THE IMPLANTS HAD TO BE EXTRACTED TO HELP ALLEVIATE THIS.

  Patient problems: Hyporesponsive to stimuli; Neuropathy; Pain

  MAUDE report 20439137 ↗
• 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 19384321 ↗
• 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 19203015 ↗
• InjuryJun 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO A +15 LONG PEGGED METAGLENE, 3 SCREWS THROUGH BASEPLATE, A 42 STANDARD GLENOSPHERE, AND A 42/+3 POLY. THE ENTIRE HUMERAL STEM WAS RETAINED AND NOT CHANGED. UNFORTUNATELY HE IS CONFIRMED FOR AN INFECTION IN SURGERY TODAY. ALL PARTS AND PIECES WERE REMOVED FROM THE PATIENT AND AN ANTIBIOTIC SPACER WAS PLACED TO TREAT THE INFECTION. DOI: (B)(6) 2020. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Unspecified Infection

  MAUDE report 17144439 ↗
• InjuryApr 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS WAS A PRIMARY SURGERY PERFORMED FOR REVERSE SHOULDER WITH DELTA XTEND ON UNKNOWN DATE IN 2022. ON (B)(6) THE SURGEON REPORTED THAT INFECTION WAS SUSPECTED VIA EMAIL. ON (B)(6) A REVISION SURGERY WAS PERFORMED, AND THE IMPLANT WAS REPLACED. WE WENT ATTENTION TO THE SALES REP TO COMPLY WITH THE PRESCRIBED REPORTING DATE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Unspecified Infection

  MAUDE report 16830963 ↗
• 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 14829432 ↗
• 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 14469985 ↗
• InjuryMay 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTED TOTAL SHOULDER. THE SURGEON DETERMINED IT BEST TO REMOVE ALL IMPLANTS AND PUT IN A COMPETITOR SPACER UNTIL THE INFECTION CLEARED. NO FURTHER PATIENT INFORMATION IS AVAILABLE AT THIS TIME. DOI: (B)(6) 2021; DOR: (B)(6) 2022; AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Unspecified Infection

  MAUDE report 14433948 ↗
• InjuryDec 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A. REVISION FOR INFECTION - WAS THERE ANY SUGGESTION BY ANYONE INDICATING THAT THERE WAS OR MAY BE DEFICIENCY WITH THE PRODUCT(S)? IF YES, PLEASE PROVIDE DETAILS. THE SURGEON DID NOT NOTE ANY DEFICIENCY WITH THE IMPLANTS CAUSING THE INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 13013867 ↗
• 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 12152086 ↗
• InjuryApr 28, 2021Osseointegration Problem; Osseointegration Problem

  THE PATIENT WAS REVISED TO ADDRESS HUMERAL FRACTURE AND LOOSENING OF THE STEM AT THE BONE TO IMPLANT INTERFACE. THE STEM/BODY WAS REPLACED WITH NEW COMPONENTS. THERE WERE NO DEFICIENCIES NOTED WITH THE IMPLANTS. THE IMPLANTS ARE UNAVAILABLE FOR RETURN. DOI: UNKNOWN, DOR: (B)(6) 2021, UNKNOWN AFFECTED SIDE.

  Patient problems: Bone Fracture(s); Inadequate Osseointegration

  MAUDE report 11737619 ↗
• InjuryMar 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION. DOI: (B)(6) 2017, DOR: (B)(6) 2021, LEFT SHOULDER.

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

  MAUDE report 11497619 ↗
• 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 10029816 ↗

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