DELTA XTEND 130720102Recalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 10603295027294), received between Oct 5, 2017 and Jan 5, 2026 — classified as 28 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Loss of Osseointegration” (3 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 25 most recent of 31 reports, in the reporter's own words as published by the FDA.

• InjuryJan 5, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DXTEND MODULAR HUM STEM D12 HA, DXTEND METAGLENE, DXTEND GLENOSPHERE ECC D38MM, DXTEND MOD EPI 1 ECC LEFT HA, UNK SHOULDER HUMERAL CUP DELTA XTEND, UNKNOWN SHOULDER LOCKING SCREW, AND UNKNOWN SHOULDER NON-LOCKING SCREW WERE INVOLVED IN A REPORTED EVENT DURING A TOTAL SHOULDER REPLACEMENT REVISION. THE REVISION WAS PERFORMED DUE TO PAIN AND LOOSENING, WITH THE GLENOID NOTED AS SIGNIFICANTLY INCLINED. THE SURGEON REVISED TO A DIFFERENT PROSTHESIS. POLYETHYLENE EDGE LOADING CAUSED UNNATURAL WEAR, AND THE EPIPHYSIS WAS REMOVED WITH LITTLE EFFORT. THE STEM WAS WELL FIXED, REQUIRING AN OSTEOTOMY FOR REMOVAL. THE GLENOSPHERE WAS REMOVED WITHOUT ISSUE, BUT THERE WAS DIFFICULTY REMOVING SCREWS, NECESSITATING SPECIAL INSTRUMENTS TO REMOVE SCREW HEADS. THE METAGLENE AND REMAINING SCREW FRAGMENTS WERE REMOVED, AND A CABLE SET WAS USED FOR THE OSTEOTOMY. METAL FRAGMENTS FROM THE SCREW REMOVAL SET WERE GENERATED BUT WERE REMOVED WITHOUT ADDITIONAL INTERVENTION. THE PROCEDURE WAS NOT DELAYED, WAS COMPLETED SUCCESSFULLY, AND NO FURTHER MEDICAL INTERVENTION WAS REQUIRED. THERE WERE NO REPORTED PATIENT CONSEQUENCES.

  Patient problems: Pain

  MAUDE report 23957710 ↗
• InjuryJan 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD INFECTED SHOULDER. ALL IMPLANTS REMOVED AND ANTIBIOTIC SPACER PLACED. NO DELAYS IN SURGERY. DOI: (B)(6) 2023. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Unspecified Infection

  MAUDE report 21081377 ↗
• 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 20439121 ↗
• InjuryJun 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. A COMPETITOR'S ANTIBIOTIC SPACER WAS BEING PLACED UNTIL INFECTION CLEARS. DOI: (B)(6) 2014. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Unspecified Infection

  MAUDE report 19624716 ↗
• MalfunctionFeb 9, 2024Nonstandard Device; Nonstandard Device

  PROCEDURE: REVERSED SHOULDER PROCEDURE DESCRIPTION OF ISSUE: MISSING THE DEGREE MARKS ON DEF. PROTHESES. EVENT OCCURRED INTRA-OP AND THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18680820 ↗
• InjuryAug 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. IT IS UNKNOWN IF THERE WAS ANY SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Pain

  MAUDE report 17577189 ↗
• InjuryAug 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A RIGHT DELTA XTEND REVERSE SHOULDER REPLACEMENT APPROXIMATELY 6 MONTHS AGO. PATIENT REPRESENTED TO SURGEON COMPLAINING OF PAIN, UNEXPLAINED ORIGIN. PROCEDURE; FIRST STAGE REVISION OF ALL COMPONENTS AND INSERTION OF GLOBAL AP HEMIARTHROPLASTY CEMENT 'SPACER'. UPON OPENING THE SHOULDER AND EXAMINING THE JOINT THE SURGEON SUSPECTED A LOW GRADE INFECTION WAS PRESENT. MULTIPLE SPECIMENS AND SWABS WERE TAKEN. DOI: UNKNOWN, DOE: (B)(6) 2023, AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 17480060 ↗
• InjuryAug 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use 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: Pain; Unspecified Infection

  MAUDE report 17450249 ↗
• InjuryJul 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ORIGINAL COMPONENTS REMOVED. REVISION FOR PERIPROSTHETIC FRACTURE. METAGLENE RETAINED.

  Patient problems: Bone Fracture(s)

  MAUDE report 17313229 ↗
• InjuryFeb 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT THE CUP WAS REVISED. THERE WERE NO REPORTED DELAYS.

  Patient problems: Bone Fracture(s)

  MAUDE report 16451710 ↗
• InjurySep 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. ALL PARTS AND PIECES WERE REMOVED TO TREAT THE INFECTION. DOI: (B)(6) 2016; DOR: (B)(6) 2022; AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Unspecified Infection

  MAUDE report 15484803 ↗
• InjuryJun 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO AN UNEXPLAINED PAIN. NO SIGN OF INFECTION. NO LOOSENING OF COMPONENTS. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2022. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Pain

  MAUDE report 14828743 ↗
• MalfunctionNov 21, 2021Difficult to Insert; Difficult to Insert

  DURING THE PROCEDURE, THE SURGEON NOTICED THAT MATING THE EPIPHYSIS TO THE STEM SEEMED MORE DIFFICULT THAN USUAL AND TRIED TWO DIFFERENT COMBINATIONS. HE SUCCESSFULLY IMPACTED ONE EPIPHYSIS TO A STEM AND ENGAGED THE ATTACHING SCREW SUCCESSFULLY IMPLANTING BOTH PIECES AND COMPLETING THE SURGERY. NO ADVERSE EVENTS OCCURRED BESIDE A 3-5 MINUTE DELAY WHEN RETRIEVING THE OTHER IMPLANTS AND THE SURGEON MANUALLY SOLVING THE ISSUE. DOE: (B)(6) 2021.

  Patient problems: Insufficient Information

  MAUDE report 12850054 ↗
• InjuryNov 19, 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 12843889 ↗
• InjuryJul 30, 2021Device Dislodged or Dislocated; Naturally Worn; Noise, Audible; Device Dislodged or Dislocated; Naturally Worn; Noise, Audible

  PATIENT UNDERWENT LEFT DELTA XTEND TOTAL SHOULDER REPLACEMENT IN (B)(6) 2019. PRESENTED BACK TO SURGEON COMPLAINING OF PAIN IN LEFT SHOULDER AND WHAT THEY DESCRIBED AS A 'CLICKING' IN THE SHOULDER JOINT UPON MOVEMENT. PROCEDURE TODAY TO EXPLORE THE LEFT SHOULDER AND PROCEED AS NECESSARY. UPON OPENING THE SHOULDER THE SURGEON NOTED THE PRESENCE OF METALLOSIS IN THE SOFT TISSUES. THE SURGEON REMARKED THAT THIS SEEMED TO BE CONCENTRATED AROUND THE TOP OF THE HUMERUS, AROUND THE EPIPHYSIS. THE SURGEON REMOVED THE POLY INSERT FORM THE EPIPHYSIS AND THE GLENOSPHERE FROM THE METAGLENE. HE EXAMINED BOTH COMPONENTS AND WAS UNABLE TO SEE ANY OBVIOUS DAMAGE OR EVIDENCE OF RUBBING ON EITHER COMPONENT. THE METAGLENE WAS DETERMINED TO BE WELL FIXED AND WAS NOT REVISED. HE THEN TURNED HIS ATTENTION TO THE HUMERAL COMPONENT, WHICH WAS A MODULAR, UNCEMENTED PROSTHESIS. HE NOTED THE PRESENCE OF METALLOSIS AROUND THE PROXIMAL HUMERUS. HE REMOVED THE EPIPHYSIS AND EXAMINED IT, NOTING THAT SOME HA COATING APPEARED TO BE RUBBED OFF THE PROSTHESIS (SEE PHOTOS IN ATTACHMENT). THE STEM WAS VERY WELL FIXED AND NOT REVISED. THE AREA WAS DEBRIDED AND WASHED OUT AND NEW PROSTHESIS OF THE SAME SPECIFICATIONS WE

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Foreign Body Reaction; Pain

  MAUDE report 12254112 ↗
• InjuryMay 5, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS PERI PROSTHETIC FRACTURE. PATIENT WAS TREATED ONE WEEK EARLIER WITH A PLATE AND CABLE WHICH FAILED. HUMERAL COMPONENT WAS REVISED TO LONG STEM, ADEQUATE REDUCTION WAS ACHIEVED. NO LOOSENING REPORTED. NO DELAY TO SURGERY. DOI: (B)(6) 2019 DOR: (B)(6) 2021 LEFT SHOULDER.

  Patient problems: Bone Fracture(s)

  MAUDE report 11777911 ↗
• InjuryApr 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REMOVAL OF OLD COMPONENTS FOR INFECTION AND ANOTHER COMPANY CEMENT SPACER WENT IN. DOI: (B)(6) 2021 DOR: (B)(6) 2021 UNK SHOULDER.

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

  MAUDE report 11711412 ↗
• InjuryMar 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION OF DELTA XTEND DUE TO INFECTION. PROSTHESIS REMOVED AND SPACER USED.

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

  MAUDE report 11574983 ↗
• InjuryMar 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION. REMOVED ALL HARDWARE. NO SURGICAL DELAY. DOI: UNKNOWN; DOR: (B)(6) 2021; LEFT SHOULDER.

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

  MAUDE report 11521369 ↗
• InjuryNov 4, 2020Loss of Osseointegration; Device Dislodged or Dislocated; Loss of Osseointegration; Device Dislodged or Dislocated

  THE PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE EPIPHYSIS FROM THE STEM AT THE BONE TO IMPLANT INTERFACE. IT WAS ALSO REPORTED THAT THE SURGEON STATED THE EPIPHYSIS ¿SPUN OUT¿. DOI: UNKNOWN, DOR: (B)(6) 2020, LEFT SHOULDER.

  Patient problems: Inadequate Osseointegration; No Code Available

  MAUDE report 10784815 ↗
• MalfunctionAug 19, 2020Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ORTHOPEDIC PROCEDURE ON (B)(6) 2020. UPON OPENING THE IMPLANT, THE INTERNAL STERILE PACKAGE WAS NOT FULLY SEALED IN A CORNER. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE EVENTS OR PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Code Available; No Consequences Or Impact To Patient

  MAUDE report 10426783 ↗
• InjuryJul 20, 2020Loss of Osseointegration; Loss of Osseointegration

  THE PATIENT WAS REVISED TO ADDRESS PERI PROSTHETIC FRACTURE AND LOOSENING OF THE STEM AT THE BONE TO IMPLANT INTERFACE. UNKNOWN CEMENT WAS USED. DOI: (B)(6) 2015, DOR: (B)(6) 2020, LEFT SHOULDER.

  Patient problems: Bone Fracture(s); Inadequate Osseointegration; No Code Available

  MAUDE report 10299194 ↗
• InjuryJun 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION SHOULDER ARTHROPLASTY: DR. (B)(6), (B)(6) HOSPITAL, (B)(6) 2020. PRIMARY IMPLANT DATE: (B)(6) 2017. PAINFUL, INFECTED PROSTHETIC JOINT, ACCORDING TO SURGEON. ALL PROSTHESIS REMOVED. PATIENT OUTCOME: STABLE SHOULDER JOINT. NO AE REPORTED. NO DELAY IN THE SURGERY. FEMALE PATIENT. (B)(6).

  Patient problems: No Code Available; Pain; Unspecified Infection

  MAUDE report 10133849 ↗
• InjuryApr 8, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LONG-STANDING HISTORY OF PAIN AND INFECTION FOR THE PAST YEAR. TREATED CONSERVATIVELY INITIALLY (LONG COURSE OF ANTIBIOTICS), THEN WASHOUT LAST YEAR. ALL PROSTHESIS, INCLUDING 4 X SCREWS, DISCARDED. THE HUMERAL STEM WAS WELL FIXED, BUT GLENOID COMPONENTS WERE VERY LOOSE. SIGNIFICANT BONE LOSS NOTED IN GLENOID. MULTIPLE SPECIMENS WERE TAKEN. ALL PROSTHESIS REMOVED. TEMPORARY ANTIBIOTIC CEMENT SPACER IMPLANTED. PATIENT OUTCOME POST SURGERY: STABLE.

  Patient problems: No Code Available; Pain; Unspecified Infection

  MAUDE report 9934100 ↗
• InjuryFeb 27, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS PAIN AND LACK OF ROM. DOI: (B)(6) 2019. DOR: (B)(6) 2020, LEFT SHOULDER.

  Patient problems: Limited Mobility Of The Implanted Joint; No Code Available; Pain

  MAUDE report 9764066 ↗

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