DELTA XTEND 130712000Recalls & reported problems

Summary

The FDA's MAUDE database contains 36 adverse event reports that list this exact device (DI 10603295027171), received between Aug 31, 2017 and Jan 5, 2026 — classified as 36 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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. 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 25 most recent of 36 reports, in the reporter's own words as published by the FDA.

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

  ADDITIONAL INFORMATION RECEIVED AND STATES THAT: "WHEN I SPOKE TO THE SURGEON, HE WAS MORE CONCERNED WITH THE ORIGINAL IMPLANT POSITIONING AND SUGGESTED THAT THAT WAS THE REASON FOR THE PATIENT PAIN AND REVISION. ON THE X-RAY THE GLENOID COMPONENT APPEARED TO HAVE SUPERIOR INCLINATION. THE UNNATURAL WEAR ON THE POLY SUGGESTS THE IMPLANT WAS NOT ARTICULATING AS IT SHOULD HAVE."

  Patient problems: Pain

  MAUDE report 23957256 ↗
• InjuryNov 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT THE REVISION OF REVERSE LEFT SHOULDER DUE TO INFECTION. THIS REPORT IS RELATED COMPLAINT (B)(4) WHICH CAPTURES ADDITIONAL IMPACTED PRODUCTS.

  Patient problems: Unspecified Infection

  MAUDE report 23569945 ↗
• InjuryNov 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT THE REMOVAL OF DELTA XTEND SHOULDER DUE TO PAIN AND SUSPECTED INFECTION. SURGEON REQUESTED THE POSITION OF THE GLENOSPHERE AND THAT THE PATIENT WAS 'NOTCHING'. THERE WAS ALSO A FRACTURED ACROMIUM. THIS SUGGESTED THE DELTOID WAS UNDER SEVERE TENSION WHEN IMPLANT INSERTED. THE DELTA XTEND WAS REMOVED AND A DJO ALTIVATE REVERSE SHOULDER WAS IMPLANTED.

  Patient problems: Pain; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 23560205 ↗
• InjuryNov 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION OF REVERSE LEFT SHOULDER. REASON FOR REVISION ¿ INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 23558493 ↗
• InjuryMay 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THAYER SCHOOL OF ENGINEERING AT DARTMOUTH FIRST REPORT OF RETRIEVALS FOR STATEMENT OF WORK 10 FOR Q1 OF 2025. DARTMOUTH IS THE RESEARCH LOCATION, AND NOT THE FACILITY OF PLACEMENT. A DEPUY SYNTHES IMPLANT WAS REVISED AND REVIEWED FOR ANALYSIS. REASON FOR REVISION: REVISION DUE TO INFECTION AND GLENOID LOOSENING. AT REMOVAL THE HUMERAL CUP SHOWED MINOR YELLOWING.

  Patient problems: Unspecified Infection

  MAUDE report 21979563 ↗
• InjuryJun 26, 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 19616024 ↗
• InjuryJun 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO INFECTED REVERSE TOTAL SHOULDER. ALL IMPLANTS WERE REMOVED AND A SPACER WAS IMPLANTED. THERE WAS NO LOOSENING. DOI: (B)(6) 2023, DOR: (B)(6) 2024, AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Unspecified Infection

  MAUDE report 19446610 ↗
• 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 17450257 ↗
• InjuryJul 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO CHRONIC INFECTION. ALL COMPONENTS REMOVED. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2010. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Unspecified Infection

  MAUDE report 17324346 ↗
• InjuryJun 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RIGHT SIDE: REVISION OF A DELTA XTEND DUE TO INFECTION. THE PATIENT HAD A PREVIOUS REVISION SURGERY A FEW YEARS AGO. UNABLE TO CONFIRM EXACT DATE. REASON FOR THIS WAS DUE TO GLENOID NOTCHING AND PAIN. AT THIS REVISION THE 155 EPI WAS REMOVED, GLENOID WAS REMOVED. UNSURE IF THE METAGLENE AND SCREWS WERE TOO. THE STEM WAS RETAINED, AND IT WAS CONVERTED TO A 145 EPI WITH LATERALISED GLENOSPHERE. PATIENT NOTES WERE UNAVAILABLE TO CONFIRM EXACT DATES AND LOT NUMBERS. I'M UNABLE TO CONFIRM WHAT PC THIS WAS LOGGED AGAINST TOO. TODAY WE REMOVED ALL IMPLANTS AS PER IMPACTED PRODUCTS. 4X SCREWS WERE ALSO REMOVED, BUT I'M UNABLE TO CONFIRM THE REF AND LOT NUMBERS FOR THESE. A SPACER WAS IMPLANTED UNTIL THE INFECTION CLEARS. WAS SURGERY DELAYED DUE TO THE REPORTED EVENT?: UNKNOWN, WAS PROCEDURE SUCCESSFULLY COMPLETED?: UNKNOWN, WERE FRAGMENTS GENERATED?: UNKNOWN, IF YES, WERE THEY REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION?: UNKNOWN, PATIENT STATUS/ OUTCOME / CONSEQUENCES: 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 POSSESSIO

  Patient problems: Unspecified Infection

  MAUDE report 17050945 ↗
• 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 16933670 ↗
• 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 16467098 ↗
• InjuryMar 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT RIGHT-SIDED REVERSE TOTAL SHOULDER I&D WAS PERFORMED FOR UNKNOWN REASON. DOI: (B)(6) 2014. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Insufficient Information

  MAUDE report 16466490 ↗
• InjuryFeb 28, 2023Migration; Migration

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

  Patient problems: Bone Fracture(s)

  MAUDE report 16451671 ↗
• 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

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 15916300 ↗
• 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 14517468 ↗
• 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 14381339 ↗
• 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 12532002 ↗
• 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: Bone Fracture(s); Inadequate Osseointegration

  MAUDE report 11999520 ↗
• 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 11777910 ↗
• 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 11711426 ↗
• InjuryApr 5, 2021Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT WAS REVISED DUE TO LOOSENING OF THE STEM AT THE CEMENT TO IMPLANT INTERFACE. UNKNOWN CEMENT WAS USED. REMOVED ALL HARDWARE AND IMPLANTED AN ANTIBIOTIC SPACER. DOI: UNKNOWN DOR: (B)(6) 2021 RIGHT SHOULDER.

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

  MAUDE report 11616637 ↗
• 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 11574977 ↗
• InjuryMar 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ORIGINAL PRIMARY OPERATION WAS IN (B)(6) 2013. PATIENT BECAME UNWELL AND THERE WAS A SUSPICION OF INFECTION. THE SHOULDER HAD PREVIOUS WASHOUTS WITH NO REAL BENEFIT. ALL IMPLANTS WERE REMOVED AND A TEMPORARY CEMENTED SPACER WAS IMPLANTED.

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

  MAUDE report 11486356 ↗
• InjuryJan 5, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION OF SPINAL HARDWARE/SHOULDER IMPLANTS. SURGEON REMOVED ALL SHOULDER IMPLANTS AND OUT IN AN ANTIBIOTIC SPACER. UPON OPENING THE JOINT HE FOUND TRACES OF METALLOSIS, SURGEON WAS UNSURE WHAT CAUSED IT. THE GLENOSPHERE WAS LOOSE AND PULLED OUT WITH A RONGEUR. THE METAGLENE BASEPLATE AND SCREWS ALL CAME OUT WITH THE GLENOSPHERE. THE INFERIOR LOCKING SCREW WAS BROKEN MIDWAY ON THE SCREW. NO FURTHER PATIENT INFORMATION IS AVAILABLE AT THIS TIME. DOI: (B)(6) 2017, DOR: (B)(6) 2020, RIGHT SHOULDER.

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

  MAUDE report 11117473 ↗

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