DELTA XTEND 130720103Recalls & reported problems

Summary

The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 10603295027300), received between Aug 31, 2017 and Jun 17, 2026 — classified as 29 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Difficult to Insert” (4 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 35 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 17, 2026Difficult to Insert

  DURING AN OPERATION THE SURGEON TRIED TO FIT THE HUMERAL CUP DEVICE INTO THE EPIPHYSIS RIGHT, DURING THIS THE HUMERAL CUP DEVICE DID NOT FIT CORRECTLY, IT WAS LOOSE INSIDE OF THE EPIPHYSIS EVEN WHEN ATTACHING. SO THE SURGEON TRIED TO FIT A NEW HUMERAL CUP BUT WITH THE SAME OUTCOME AS THE FIRST ONE. WHEN OPENING A NEW EPIPHYSIS DEVICE THE HUMERAL CUP DEVICE WAS SEATED CORRECT AND FIRMLY. JOINT RECONSTRUCTION SIDE AFFECTED: RIGHT SIDE QUANTITY AFFECTED: 2 . WAS THERE ANY REPORTED PATIENT OR USER HARM? NO. WAS THERE A SIGNIFICANT DELAY? UNKNOWN. WOULD YOU LIKE A RETURN LABEL AT THE END OF THIS PROCESS? YES. THIS PARCEL CONTAINS BIOHAZARDOUS MATERIALS AND/OR MATERIALS USED DURING A MEDICAL PROCEDURE YES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25536483 ↗
• InjuryJan 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT SHOULDER WAS REVISED DUE TO FRACTURE/DISLOCATION. DOI: ON (B)(6) 2017, DOR: ON (B)(6) 2024, AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Bone Fracture(s)

  MAUDE report 21085620 ↗
• InjuryDec 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ALL IMPLANTS WERE REMOVED DUE TO INFECTION. DOI: (B)(6) 2022, DOR:(B)(6) 2024 , AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Unspecified Infection

  MAUDE report 20848685 ↗
• InjuryMay 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAS CATASTROPHIC FAILURE. PUT A NEW GLENOSPHERE IN AND A SPACER. THIS IS A PATIENT WHO HAS BEEN REVISED MULTIPLE TIMES. DOI: (B)(6) 2015 DOR: (B)(6) 2024 AFFECTED SIDE : RIGHT SHOULDER .

  Patient problems: Pain; Unspecified Infection

  MAUDE report 19304452 ↗
• InjuryOct 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD THE RIGHT SHOULDER REPLACED FIVE YEARS AGO WHERE THEY RECEIVED A DELTA EXTEND REVERSE SHOULDER CONSTRUCT. PATIENT RECENTLY CAME TO DOCTOR BECAUSE OF RIGHT SHOULDER PAIN, X-RAYS REVEALED THAT COULD BE A STEEL LYSIS. IT¿S SEVERE BONE LOSS AROUND THE IMPLANTS. DOCTOR REVISE THE SHOULDER, EXPLANTED AND METAGLENE COMPONENT, GLENOSPHERE, FOUR SCREWS, AND THE PROXIMAL BODY. THE LOT NUMBERS FOR THE HUMERAL CUP AND THE FOUR SCREWS WERE ILLEGIBLE. THE HUMERUS STEM WAS LEFT IN SITU, AND A NEW PROXIMAL BODY WAS PUT ON. BECAUSE OF THE SEVERE BONE LOSS IN THE GLENOID, A CTA HEAD WAS UTILIZED. DOI: UNKNOWN, DOR: (B)(6) 2023, AFFECTED SIDE: RIGHT SHOULD.

  Patient problems: Pain; Unspecified Tissue Injury

  MAUDE report 17952235 ↗
• 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 16830967 ↗
• InjuryMar 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR SEROMA SCAR RIGHT SHOULDER. EVENT IS NOT SERIOUS AND IS CONSIDERED MILD. EVENT IS POSSIBLY RELATED TO PROCEDURE. EVENT IS NOT RELATED TO DEVICE. DATE OF IMPLANT: (B)(6) 2023. DATE OF EVENT: (B)(6) 2023. (RIGHT SHOULDER). TREATMENT: ASPIRATION/DRAINAGE AND ORAL MEDICATION (PROPHYLACTIC FLUCLOXACILLIN 500 MG)

  Patient problems: Adhesion(s); Seroma

  MAUDE report 16467096 ↗
• InjuryDec 5, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS WAS A RTSA PERFORMED IN 2020. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. AFTER SURGERY, ON (B)(6) 2022, THE SALES REP WAS INFORMED BY THE SURGEON THAT THE PATIENT HAD A DELAYED INFECTION. THE SALES REP SUGGESTED TO THE SURGEON THAT THE TREATMENT SHOULD BE PERFORMED BY DEBRIDEMENT IF THE INFECTION WAS MILD OR BY REMOVING THE IMPLANT, DOING DEBRIDEMENT, AND FILLING CEMENT BEADS CONTAINING ANTIBIOTICS IF THE INFECTION WAS SEVERE, ETC. HOWEVER, WHEN THE SITUATION WAS CHECKED AGAIN, THE FOLLOWING SITUATIONS WERE FOUND.; SOME DISEASE DEVELOPED IN THE AXILLA AFTER SURGERY, AND THE PATIENT VISITED THE DERMATOLOGY DEPARTMENT. SINCE THE CONDITION DID NOT IMPROVE, THE SURGEON BEGAN TO SUSPECT THAT THE INFECTION WAS CAUSED BY THE IMPLANTS USED IN THE INITIAL SURGERY. ULCER AND GRANULATION HAVE FORMED IN THE AXILLA, AND MRSA HAS BEEN ATTACHED FROM THE SKIN. THE SURGEON COMMENTED THAT THE CAUSE OF INFECTION WAS PROPIONIBACTERIUM ACNES. SLIGHT OSTEOLYSIS IS OBSERVED ON THE STEM SITE MEDIALLY, BUT THERE IS NO INSTABILITY BOTH ON THE BASE PLATE SITE AND STEM SITE SO FAR. BECAUSE THE INFECTION WAS EXPECTED TO BE QUITE SEVERE, THE SALES REP SUGGESTED TO T

  Patient problems: Unspecified Infection

  MAUDE report 15916301 ↗
• InjuryJul 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO A HEMI DUE TO PAIN. NO SURGICAL DELAY. DOI: UNKNOWN, DOR: (B)(6) 2022, AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Pain

  MAUDE report 14948568 ↗
• InjuryMay 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO INFECTION AND LOOSENING OF THE METAGLENE AT THE BONE TO IMPLANT INTERFACE. ALL IMPLANTS WERE REMOVED AND TEMPORARY SPACER PLACED IN. CULTURES SENT. THE SURGEON DESCRIBED THE PATIENT AS HAVING POOR PROTOPLASM AND GENERALLY UNHEALTHY OVERALL. DOI: (B)(6) 2018. DOR: (B)(6), 2022. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Unspecified Infection

  MAUDE report 14517332 ↗
• 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 14433905 ↗
• InjuryMay 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ALL IMPLANTS WERE REMOVED DUE TO CONFIRMED INFECTION OF RIGHT SHOULDER. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2019. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Unspecified Infection

  MAUDE report 14381350 ↗
• InjuryNov 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO PRESENT OF INFECTION. I&D WASHOUT WITH IMPLANT EXCHANGE WERE PERFORMED. ALL COMPONENTS HAD SOLID FIXATION. ORIGINAL IMPLANTATION WAS (B)(6) 2020. SHE HAD ANOTHER WASHOUT IN (B)(6) 2021. DOI: (B)(6) 2020, (B)(6) 2021 (GLENOSPHERE, METAGLENE AND PE CUP, DOR: (B)(6) 2021, RIGHT SHOULDER.

  Patient problems: Unspecified Infection

  MAUDE report 12861779 ↗
• InjuryNov 16, 2021Osseointegration Problem; Osseointegration Problem

  PATIENT WAS REVISED DUE TO LOOSENING OF ALL COMPONENTS AT THE BONE TO IMPLANT INTERFACE. DOI: (B)(6) 2019, DOR: (B)(6) 2021, RIGHT KNEE.

  Patient problems: Inadequate Osseointegration

  MAUDE report 12820677 ↗
• InjuryOct 12, 2021Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available

  MEDICAL RECORDS RECEIVED. THE PATIENT IN THE YEAR 2018 HAD SURGERY FOR THE REMOVAL OF SYNOVIAL CYSTS IN THE RIGHT SHOULDER REVERSE PROSTHESIS. THE PATIENT IN THE YEAR 2019 ((B)(6) 2019) HAS A REVISION SURGERY DUE TO METALLOSIS TO REMOVE THE IMPLANT AND REVERSE ARTHROPROSTHESIS AND BONE GRAFT. COMPETITOR PRODUCTS WERE USED IN THE REVISION AS REPLACEMENTS.

  Patient problems: Foreign Body Reaction; Pain

  MAUDE report 12619016 ↗
• MalfunctionSep 10, 2021Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT WHILE TRYING TO ASSEMBLE THE EPIPHYSIS TO THE 10 UNITE STEM IT WAS NOTED THE TWO COMPONENTS WOULD NOT SLIDE TOGETHER ON THE EPIPHYSIS POST. UNSURE OF WHICH COMPONENT MAY BE THE ISSUE. SURGEON FELT THE ISSUE WAS THE EPIPHYSIS. ANOTHER ONE WAS OPENED AND THE TWO COMPONENTS WERE ASSEMBLED WITH NO PROBLEMS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12452589 ↗
• 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 11737618 ↗
• InjuryDec 8, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION OF A DELTA XTEND FOR PAIN. THE SURGEON WANTED TO UPSIZE THE GLENOSPHERE FROM A 38 TO A 42 AND CHANGE THE POLY CUP. ONCE THE CUP WAS REMOVED THE SURGEON DECIDED TO REMOVED THE EPIPHYSIS AS THERE WAS A LOT OF BONE REABSORPTION INDICATIVE OF AN INFECTION. HE ALSO OBSERVED THAT THE GLENOSPHERE WAS LOOSE. WE OBSERVED THAT IT WAS INFECTED AFTER REMOVING THE GLENOSPHERE AS THERE WAS A LOT OF 'GUNK' BEHIND THE GLENOSPHERE ON THE FACE OF THE METAGLENE. THE SCREWS AND METAGLENE WERE WELL FIXED. STEM WAS WELL FIXED. ADDITIONAL INFORMATION RECEIVED: DATE OF IMPLANTATION (PRIMARY SURGERY). EXACT DATE UNKNOWN BUT IT WAS IN 2013. PRODUCT AND LOT NUMBER OF THE METAGLENE. METAGLENE LOT NUMBER UNKNOWN, BUT IT WAS NOT REMOVED AS IT WAS STABLE ALONG WITH THE SCREWS. PLEASE CLARIFY WHAT YOU MEAN BY GUNK BEHIND THE GLENOSPHERE ON THE FACE OF THE METAGLENE? BY 'GUNK' I MEAN THERE WAS TISSUE BEHIND THE GLENOSPHERE ON THE FACE OF THE METAGLENE WHICH LOOKED LIKE INFECTED TISSUE.

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

  MAUDE report 10971826 ↗
• InjurySep 22, 2020Difficult to Insert; Device Dislodged or Dislocated; Difficult to Insert; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE EPI 1 RIGHT XTEND IMPLANT WAS NOT ENGAGED WITH THE STEM. REVISION WAS PERFORMED TO REMOVE BONE AND ENGAGE PROSTHESIS. DOI: (B)(6) 2020, DOR: (B)(6) 2020, RIGHT SHOULDER.

  Patient problems: No Code Available

  MAUDE report 10568021 ↗
• InjurySep 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION OF A DEPUY SYNTHES DELTA XTEND. TWO STAGE REVISION. THE REASON FOR REVISION WAS DUE TO INFECTION, NOT COMPONENT FAILURE. GLENOSPHERE, CUP, AND EPIPHYSIS WERE REMOVED. SITE WAS CLEANED AND DEBRIDED. NEW COMPONENTS WERE THEN IMPLANTED. THE PRODUCTS REMOVED ARE LISTED IN IMPACTED PRODUCTS. DID THE PATIENT EXPERIENCE A POST-OP DEVICE MALFUNCTION?: UNKNOWN, DID THE PATIENT EXPERIENCE AN ADVERSE EVENT SUCH AS INFECTION, NON-UNION, ALLERGIC REACTION, OSTEOPOROSIS, OVERLOADING, PAIN, DEGENERATIVE DISEASES, BLEEDING OR OOZING?: UNKNOWN, DID THE PATIENT REQUIRE REVISION SURGERY OR HARDWARE REMOVAL? : UNKNOWN, PATIENT STATUS/ OUTCOME / CONSEQUENCES: UNKNOWN, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: UNKNOWN, IS THE PATIENT PART OF A CLINICAL STUDY: UNKNOWN, (B)(4). DEVICE PROPERTY OF: NONE, DEVICE IN POSSESSION OF: NONE, (B)(4). DEVICE PROPERTY OF: NONE, DEVICE IN POSSESSION OF: NONE, (B)(4). DEVICE PROPERTY OF: NONE, DEVICE IN POSSESSION OF: NONE. BY CHECKING THIS BOX I CERTIFY THAT ALL INFORMATION THAT ARE KNOWN/AVAILABLE HAS BEEN DISCLOSED. IF ANY NEW INFORMATION WILL BE MADE AVAILABLE, THE ADDITIONAL INFORMATION WI

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10508189 ↗
• InjuryJun 24, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO PERI PROSTHETIC FRACTURE. DOI: (B)(6) 2016, DOR: (B)(6) 2020, RIGHT SHOULDER.

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

  MAUDE report 10192085 ↗
• InjuryJun 19, 2020Loss of Osseointegration; Loss of Osseointegration

  THE PATIENT WAS REVISED TO ADDRESS INFECTION AND LOOSENING OF THE STEM AT THE BONE TO IMPLANT INTERFACE. THE SURGEON WAS PLANNING ON DOING AN I&D OF A REVERSE TSA AND ONCE HE GOT INTO THE SHOULDER JOINT, THE PRESSFIT GLOBAL UNITE STEM WAS LOOSE SO HE TOOK OUT THE STEM, MODULAR EPIPHYSIS, HUMERAL CUP AND LATERALIZED GLENOSPHERE AND IMPLANTED A NEW LATERALIZED GLENOSPHERE, CEMENTED MONOBLOC STEM AND A HUMERAL CUP. NO HEIGHT AND WEIGHT WAS AVAILABLE AT THAT TIME. DOI: (B)(6) 2020, DOR: (B)(6) 2020, RIGHT SHOULDER.

  Patient problems: Inadequate Osseointegration; No Code Available; Unspecified Infection

  MAUDE report 10175378 ↗
• InjuryDec 17, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS INSTABILITY. DOI: UNK; DOR: (B)(6) 2019; RIGHT SHOULDER.

  Patient problems: No Code Available; Not Applicable

  MAUDE report 9483266 ↗
• MalfunctionNov 25, 2019Difficult to Insert; Inadequacy of Device Shape and/or Size; Difficult to Insert; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT STEM AND EPIPHYSIS DO NOT MATE TOGETHER PROPERLY. IMPLANTS DEFECTIVE NEED TO BE RETURNED TO DEPUY. RIGHT SHOULDER.

  Patient problems: No Code Available; Not Applicable

  MAUDE report 9369156 ↗
• InjuryNov 22, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INFECTION. CONVERTED TO CEMENT SPACERS. DOI: UNKNOWN; DOR: (B)(6) 2019; RIGHT SHOULDER.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9363834 ↗

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