DELTA XTEND 130720201Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10603295027317), received between Nov 8, 2017 and Aug 23, 2024 — classified as 10 injuries.

The most frequently reported specific device problem is “Osseointegration Problem” (2 reports).

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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryAug 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE INFECTION. IMPLANT WAS REMOVED. DOI: (B)(6) 2023. DOR: (B)(6) 2024. AFFECTED SIDE: UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 20054424 ↗
• 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 19711437 ↗
• InjuryMay 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO SHOULDER INFECTION AND SURGEON REMOVED HARDWARE, IRRIGATED AND IMPLANTED A SPACER. DOI: UNKNOWN, DOR: (B)(6) 2023, AFFECTED SIDE : RIGHT SHOULDER.

  Patient problems: Unspecified Infection

  MAUDE report 16859786 ↗
• InjuryFeb 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO PAIN. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Pain

  MAUDE report 16432870 ↗
• InjuryMar 10, 2022Adverse 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. THERE WAS NO SURGICAL DELAY REPORTED. DOI: UNKNOWN, DOR: (B)(6) 2022, AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Unspecified Infection

  MAUDE report 13720154 ↗
• InjurySep 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SURGERY: REVISION OF LEFT SHOULDER DELTA XTEND . REASON FOR REVISION - INFECTION. THE 42MM SCREW WAS VERY DIFFICULT TO REMOVE AND DELAYED THE OPERATION BY APPROXIMATELY ONE HOUR. INITIALLY UNLOCKED SCREW WITH LOCKING SCREWDRIVER INTERNAL ROD AND THEN USED LOCKING SCREWDRIVER (WITHOUT INTERNAL ROD) TO UNSCREW IT. HOWEVER ONE OF THE ¿PRONGS¿ FROM THE TOP OF THE SCREW SHEARED OFF SO THE LOCKING SCREW DRIVER WOULD NOT GRIP/ENGAGE PROPERLY TO UNSCREW IT. THE SURGEON HAD TO DRILL THROUGH THE SCREW CENTRALLY AND USE THE TRUSTS SCREW REMOVAL INSTRUMENTS TO REMOVE THE SCREW AND IT CAME OUT IN 3 OR 4 PARTS. ALL IMPLANTS WERE RETAINED BY THE HOSPITAL. NO ADVERSE CONSEQUENCES DURING SURGERY. PRIMARY SURGERY CONDUCTED ON - (B)(6) 2021

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

  MAUDE report 12532005 ↗
• InjuryAug 31, 2021Osseointegration Problem; Osseointegration Problem

  THE PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE GLENOSPHERE AND STEM AT THE IMPLANT TO BONE INTERFACE. THE GLENOSPHERE WAS UNATTACHED FROM THE METAGLENE. NO SURGICAL DELAY. DOI: (B)(6) 2019, DOR: (B)(6) 2021, RIGHT SHOULDER.

  Patient problems: Inadequate Osseointegration

  MAUDE report 12399360 ↗
• InjuryJun 15, 2021Osseointegration Problem; Osseointegration Problem

  THE PATIENT WAS REVISED TO ADDRESS PERIPROSTHETIC FRACTURE AND LOOSENING OF THE HUMERAL STEM AT THE BONE TO IMPLANT INTERFACE. ALL IMPLANTS WERE REMOVED AND REPLACED WITH COMPETITOR PRODUCTS. DOI: (B)(6) 2016, DOR: (B)(6) 2021, RIGHT SHOULDER.

  Patient problems: Inadequate Osseointegration

  MAUDE report 11999518 ↗
• 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 11497618 ↗
• InjuryNov 8, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS REVISED TO ADDRESS INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 7009483 ↗

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