DELTA XTEND 130720202Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10603295027324), received between Mar 21, 2019 and Nov 21, 2024 — classified as 8 injuries.

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 8 most recent of 8 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 20752456 ↗
• 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 17144409 ↗
• InjuryMay 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION OF LEFT REVERSE SHOULDER REPLACEMENT FOR SUSPECTED INFECTION - PATIENT EXPERIENCING PAIN AND SIGNS OF LOOSENING ON X-RAY. TEST RESULTS SHOWED ELEVATED LEVELS INDICATING POTENTIAL INFECTION. OPEN SAMPLES WERE TAKEN, PUS WAS FOUND. ALL IMPLANTS REMOVED. SURGEON FLUSHED AND TREATED THE AREA AND PUT IN AN ANTIBIOTIC SPACER. WILL COME BACK FOR 2ND STAGE REVISION ONCE INFECTION CLEARED. DOI: (B)(6) 2020; DOR: (B)(6) 2023; LEFT SHOULDER.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 16934897 ↗
• InjuryNov 10, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RECURRENT DISLOCATION, METALLOSIS AND INFECTION AS A RESULT. REVISED TO MONOBLOCK STEM WITH CTA HEAD.

  Patient problems: Foreign Body Reaction; Unspecified Infection

  MAUDE report 12789161 ↗
• InjuryMar 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON WEDNESDAY, (B)(6) 2021, DR. REVISED A LEFT REVERSE SHOULDER FOR INFECTION. THE REVERSE SHOULDER WAS IMPLANTED IN THIS PATIENT ON (B)(6) 2020 BY ANOTHER DR. CULTURES TAKEN IN CLINIC A WEEK AGO CAME BACK WITH GROWTHS THIS MORNING AND DR. ELECTED TO PERFORM A TWO STAGE REVISION FOR INFECTION. UPON EXPOSING THE LEFT SHOULDER JOINT SPACE, DR. FOUND THE ENTIRE GLENOID CONSTRUCT OF A METAGLENE, FOUR SCREWS (INDETERMINABLE IF THE SCREWS WERE LOCKING OR NON LOCKING, AND LENGTHS WERE INDETERMINABLE AS WELL AS WERE LOT CODES) AND 38 ECCENTRIC GLENOSHPERE, TO BE LOOSE AT THE BONE/IMPLANT INTERFACE. DR. WAS ABLE TO REMOVE THE ENTIRE GLENOSHPERE CONSTRUCT BY HAND. DR. REMOVE THE 38 +9 LINER WITH AN OSTEOTOME. DR. THEN REMOVED THE SIZE 2 LEFT EPIPHYSIS WITH AN OSTEOTOME AND MALLET AND THE YELLOW SCREWDRIVER. DR. THEN REMOVED THE SZ 12 STANDARD DISTAL STEM WITH OSTEOTOMES AND THE T HANDLE. THE HUMERAL CONSTRUCT WAS WELL FIXED. DR. THEN CREATED HIS OWN ANTIBIOTIC SPACER WITH NON-DEPUY CEMENT AND IMPLANTED THAT. THERE WERE NO DELAYS IN THE CASE. NO INSTRUMENTATION BROKE DURING THE CASE. THERE WAS NO INDICATION BY THE SURGEON THAT HE THOUGHT THE IMPLANTS DIDN'T PERFORM AS EXPECTED. THERE WAS NO CE

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

  MAUDE report 11438358 ↗
• InjurySep 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. DOI: (B)(6) 2020 DOR: (B)(6) 2020 LEFT SHOULDER.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10484423 ↗
• InjuryOct 15, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  1ST STAGE REVISION SHOULDER ARTHROPLASTY. APPROXIMATELY 9 MONTH HISTORY OF DISCOMFORT AND REDUCED RANGE OF MOTION. SERUM CLINICAL MARKERS, AS STATED BY DR. (B)(6), INDICATED INFECTION IN PROSTHETIC SHOULDER JOINT. ALL PROSTHESIS REMOVED. HUMERAL OSTEOTOMY REQUIRED TO REMOVED WELL FIXED STEM. MULTIPLE TISSUE SPECIMENS TAKEN. TURBID FLUID ASPIRATED FROM JOINT PRIOR TO JOINT BEING OPENED.

  Patient problems: Discomfort; Limited Mobility Of The Implanted Joint; No Code Available; Unspecified Infection

  MAUDE report 9194268 ↗
• InjuryMar 21, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SHOULDER INFECTED. REMOVED EPIPHYSIS AND GLENOSPHERE AND REPLACED. PRIMARY IMPLANT DATE IS UNKNOWN. NO AE REPORTED, NO DELAY IN THE SURGERY.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8439914 ↗

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-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