DELTA XTEND 130790042Recalls & reported problems

Summary

The FDA's MAUDE database contains 72 adverse event reports that list this exact device (DI 10603295027867), received between Sep 19, 2017 and Sep 14, 2026 — classified as 51 injuries, 21 malfunctions.

The most frequently reported specific device problem is “Fracture” (18 reports).

10 other recalls cover devices cleared under the same FDA submission (K062250, K081620, K120174, 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 72 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 14, 2026Fracture

  It was reported that after a surgical procedure, the screw head sheared off during implantation in to metaglene. The fragments were removed. The remaining screw left in-situ. The surgeon is confident that fixation was not greatly compromised.Side Affected: Left Side List any J&J products that were utilized during the case but did not contribute to the reported event. Delta Xtend Reverse Shoulder SystemWas there any reported patient or user harm? NoWas there a significant delay? No

  Patient problems: Foreign Body In Patient

  MAUDE report 50756686 ↗
• MalfunctionJun 2, 2026Fracture

  IT WAS REPORTED THAT DURING AN UNKNOWN SURGERY, THE LOCKING SCREW WAS INSERTED INTO THE METAGRAIN OF THE SUPERIOR AND BECAME STUCK MIDWAY. WHEN THE SCREWDRIVER WAS TURNED FURTHER, THE SCREW HEAD BROKE. ALL FRAGMENTS WERE CONFIRMED AND REMOVED. IT WAS DETERMINED THAT THE FIXATION FORCE AT THE CURRENT INSERTION POINT WAS SUFFICIENT. REMOVAL OF THE SCREW WAS NOT POSSIBLE, SO THE SURGEON LEFT IT IN PLACE AND CONTINUED THE SURGERY. THE SURGERY WAS DELAYED BY WITHIN THIRTY MINUTES. THERE WAS NO HARM TO THE PATIENT. POSTOPERATIVE IMAGES CONFIRMED NO LOOSENING OR REMAINING FRAGMENTS. THE SURGEON PLANNED TO CONTINUE MONITORING THE SITUATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 25363114 ↗
• InjuryMay 27, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT REVISED DUE TO INFECTION. EVERYTHING TAKEN OUT. DOI: (B)(6) 2024. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT.

  Patient problems: Unspecified Infection

  MAUDE report 25302121 ↗
• InjuryJan 29, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A FRACTURE AND JOINT INSTABILITY, NECESSITATING A REVISION PROCEDURE IN WHICH THE ORIGINAL IMPLANTS WERE REPLACED WITH A CTA HEAD FOR INCREASED STABILITY. DOI: (B)(6) 2021. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Bone Fracture(s); Joint Laxity

  MAUDE report 24211277 ↗
• MalfunctionJan 7, 2026Fracture; Difficult to Insert

  IT WAS REPORTED THAT DURING A REVERSE SHOULDER ARTHROPLASTY SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE SCREW THREADS PEELED AND COULD NOT LOCK. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23995871 ↗
• 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: Bone Fracture(s); Pain; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 23560200 ↗
• 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 23558424 ↗
• InjuryNov 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS COMPLAINING OF HUMERAL PAIN. STEM WAS FOUND TO BE IN GOOD STABLE CONDITION AS WELL AS METAGLENE. SURGEON REPLACED SCREWS, GLENOSPHERE AND PLOY TO BIGGER SIZES TO GIVE MORE STABILITY. DOI: (B)(6) 2024. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Joint Laxity; Pain

  MAUDE report 23488259 ↗
• InjurySep 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO HEMIARTHROPLASTY DUE TO INSTABILITY. DOI: (B)(6) 2022. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Joint Laxity

  MAUDE report 23031118 ↗
• InjurySep 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO HEMIARTHROPLASTY DUE TO INSTABILITY. DOI: (B)(6) 2022. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Joint Laxity

  MAUDE report 23031115 ↗
• InjuryJul 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT REMOVAL OF DELTA XTEND DUE TO INFECTION. DOI: UNKNOWN 2015. DOR: (B)(6) 2025. AFFECTED SIDE: UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 22462397 ↗
• InjuryFeb 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD SOME ANTERIOR SHOULDER PAIN, BELIEVED TO BE RELATED TO THE PATIENT'S SUBSCAP REPAIR. SURGEON SAID THE BONE SCAN SHOWED THE METAGLENE TO POTENTIALLY BE LOOSE. THE SURGEON REMOVED THE GLENOSPHERE AND SCREWS TO ASSESS THE METAGLENE. IT WAS WELL FIXED, BUT THE SURGEON FELT IT WAS BEST TO REPLACE IT BECAUSE OF THE STRESS PUT ON THE METAGLENE WHILE TESTING IT OUT. THERE WERE NO DELAYS. NO COMMENTS OR CONCERNS WERE EXPRESSED ABOUT THE QUALITY OF PRODUCTS. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Pain; Unspecified Tissue Injury

  MAUDE report 21306966 ↗
• 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: ON (B)(6) 2022, DOR: ON (B)(6) 2024, AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Unspecified Infection

  MAUDE report 20848627 ↗
• InjuryJun 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY NO DOTS. CLINICAL ADVERSE EVENT RECEIVED FOR SUSPICION OF PROSTHETIC INFECTION - LEFT SHOULDER. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS NOT RELATED TO DEVICE OR PROCEDURE. DATE OF IMPLANT: (B)(6) 2024. DATE OF EVENT: (B)(6) 2024. (LEFT SHOULDER). TREATMENT: I&D. NO REVISION COMPLETED.

  Patient problems: Unspecified Infection

  MAUDE report 19562900 ↗
• InjuryMay 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. EVERYTHING WAS EXPLANTED AND A SPACED WAS PUT IN. DOI: (B)(6) 2023 DOR: (B)(6) 2024 AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 19384221 ↗
• MalfunctionApr 17, 2024Fracture; Device-Device Incompatibility; Fracture; Device-Device Incompatibility

  ADDITIONAL INFORMATION RECEIVED. A. WAS THERE ANY PATIENT HARM RELEVANT TO THIS EVENT? IF YES, PLEASE KINDLY PROVIDE DETAILS. NO PATIENT HARM, DURING THIS EVENT. B. DID IT BREAK INTO TWO OR MORE PIECES? IF NO, PLEASE SPECIFY, THE ALLEGED DEFICIENCY OF THE INSTRUMENTS. WERE THEY BENT, STRIPPED, CROSS-THREADED, ETC.? YES THE HEAD OF THE SCREW BROKE OFF THE SHAFT. 2 PIECES. C. DID THE EVENT OCCUR, DURING PRIMARY OR REVISION SURGERY? PRIMARY SURGERY.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19123890 ↗
• MalfunctionFeb 26, 2024Fracture; Fracture

  IT WAS REPORTED THAT THIS WAS AN UNKNOWN SURGERY PERFORMED ON (B)(6) 2024. THE LOCKING SCREW IN QUESTION WAS USED FOR METAGLENE FIXATION. WHEN THE SCREWDRIVER WAS TURNED FOR LOCKING, THE INSIDE PART CAME OFF AND COULD NOT BE LOCKED. IT WAS REMOVED FROM THE BODY, AND A NEW SCREW WITH SAME SIZE WAS USED FOR SURGERY. THERE WAS NO SURGICAL DELAY AND NO HARM TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18785481 ↗
• MalfunctionJan 11, 2024Fracture; Fracture

  IT WAS REPORTED THAT THE NUT FELL OUT OF A CENTER LOCKING SCREW AND HAD TO OPEN A NEW ONE. UNKNOWN SURGICAL DELAY. DOE: (B)(6) 2024. AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18491036 ↗
• InjuryJan 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INSTABILITY. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: UNKNOWN SHOULDER.

  Patient problems: Joint Laxity

  MAUDE report 18483549 ↗
• InjuryJan 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INSTABILITY. DOI: UNKNOWN DOR: (B)(6) 2024 AFFECTED SIDE: UNKNOWN SHOULDER.

  Patient problems: Joint Laxity

  MAUDE report 18483540 ↗
• MalfunctionNov 1, 2023Fracture; Fracture

  IT WAS REPORTED THAT THE SCREW HEAD WAS BROKEN. FIVE MINUTE SURGICAL DELAY TO CHANGE SCREW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18046090 ↗
• 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: ON (B)(6) 2020, DOR: ON (B)(6) 2023, AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Unspecified Infection

  MAUDE report 17144551 ↗
• 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 16936264 ↗
• 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 16933663 ↗
• 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 16830964 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K062250, K081620, K120174, 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
• Z-0539-2009 · Jul 10, 2008 · Terminated
  Depuy DELTA Xtend, Standard Humeral PE Cup, Dia 42+6R RET, sterile, Depuy France; REF 130742106. The device is used as a shoulder implant.
• Z-0533-2009 · Jul 10, 2008 · Terminated
  Depuy DELTA Xtend, Standard Humerus PE Cup, Dia 38/+6 STD, sterile, Depuy France; REF 130738206. The device is used as a shoulder implant.
• Z-0532-2009 · Jul 10, 2008 · Terminated
  Depuy DELTA Xtend, Standard humeral PE Cup Dia 38/+3 STD, sterile, Depuy France; REF 130738203. The device is used as a shoulder implant.
• Z-0534-2009 · Jul 10, 2008 · Terminated
  Depuy DELTA Xtend, Standard Humeral PE Cup, Dia 38/+9 STD, sterile, Depuy France; REF 130738209. The device is used as a shoulder implant.
• Z-0535-2009 · Jul 10, 2008 · Terminated
  Depuy DELTA Xtend, Standard Humeral PE Cup, Dia 38/+6R RET, sterile, Depuy France; REF 130738106. The device is used as a shoulder implant.
• Z-0536-2009 · Jul 10, 2008 · Terminated
  Depuy DELTA Xtend, Standard Humeral PE Cup, Dia 42/+3 STD, sterile, Depuy France; REF 130742203. The device is used as a shoulder implant.
• Z-0537-2009 · Jul 10, 2008 · Terminated
  Depuy DELTA Xtend, Standard Humeral PE Cup, Dia 42/+6 STD, sterile, Depuy France; REF 130742206. The device is used as a shoulder implant.
• Z-0538-2009 · Jul 10, 2008 · Terminated
  Depuy DELTA Xtend, Standard Humeral PE Cup, Dia 42/+9 STD, sterile, Depuy France; REF 130742209. The device is used as a shoulder implant.