DELTA XTEND 130760042Recalls & reported problems

Summary

The FDA's MAUDE database contains 66 adverse event reports that list this exact device (DI 10603295027751), received between Aug 2, 2017 and Dec 31, 2025 — classified as 60 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (27 reports).

10 other recalls cover devices cleared under the same FDA submission (K062250, 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 66 reports, in the reporter's own words as published by the FDA.

• InjuryDec 31, 2025Fracture; Device Dislodged or Dislocated; Fracture; Device Dislodged or Dislocated

  IT WAS REPORTED THE PATIENT WAS REVISED DUE TO PAINFUL RIGHT SHOULDER. IT WAS NOTED THE GLENOSPHERE APPEARED TO BE TILTED FROM METAGLENE. THE IMPLANTS WERE REMOVED AND REPLACED. IT WAS NOTED THERE WAS A POSSIBLE INFECTION IN THE SHOULDER AND A POSSIBLE BREAK ON THE POST AT THE BOTTOM OF GLENOSPHERE AND PIECE IN THE METAGLENE POST. DOI: (B)(6) 2019. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 23935479 ↗
• InjuryJun 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS INFECTED. THE SURGEON REMOVED THE POLY, GLENOSPHERE, METAGLENE AND SCREWS. THE SURGEON REMOVED 3 LOCKING SCREWS; HOWEVER, THE PRODUCT NUMBERS ARE NOT AVAILABLE. ALSO THE POLY WAS WORN ON THE ANTERIOR FACE SO THE PRODUCT NUMBER OR LOT NUMBER WERE UNREADABLE. THE SURGEON CONVERTED IT TO A CTA HEMI. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Unspecified Infection

  MAUDE report 22293255 ↗
• 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 19616001 ↗
• 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 19562870 ↗
• InjuryApr 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR INFECTION. 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 (RIGHT SHOULDER) TREATMENT: INJECTED MEDICATION

  Patient problems: Unspecified Infection

  MAUDE report 19203137 ↗
• InjuryMar 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS COMPLAINING OF PAIN. THE SURGEON CONVERTED THE 155 EPIPHYSIS TO 145 AND DOWNSIZED THE GLENOSPHERE TO 38. ALL COMPONENTS WERE WELL FIXED. SURGICAL DELAY WAS UNKNOWN. DOI: (B)(6) 2020 DOR: (B)(6) 2024 AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Pain

  MAUDE report 18966078 ↗
• InjuryFeb 15, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED DUE TO PAIN. HE HAS HAD MULTIPLE FALLS. NO OTHER INFORMATION. IT WAS UNKNOWN IF THERE WAS ANY SURGICAL DELAY. DOI: UNKNOWN, DOR: ON (B)(6) 2024, AFFECTED SIDE: LEFT.

  Patient problems: Fall; Pain

  MAUDE report 18715370 ↗
• MalfunctionFeb 5, 2024Fracture; Fracture

  IT WAS REPORTED THAT THE SCREW OF GLENOSPHERE BROKE. SURGICAL DELAY UNKNOWN. DOI: UNKNOWN, DOR: ON (B)(6) 2024, AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Insufficient Information

  MAUDE report 18638990 ↗
• InjuryNov 28, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  SUBJECT ID: (B)(6). STUDY NO: DOTS. CLINICAL ADVERSE EVENT RECEIVED FOR DISLOCATION OF THE REVERSED SHOULDER PROSTHESIS. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO DEVICE. EVENT IS NOT RELATED TO PROCEDURE. DATE OF IMPLANT: (B)(6) 2023. DATE OF EVENT: 07 NOV 2023. (RIGHT SHOULDER). TREATMENT: CLOSED REDUCTION/MANIPULATION.

  Patient problems: Joint Dislocation

  MAUDE report 18220597 ↗
• InjuryNov 27, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  STUDY NO: DOTS. CLINICAL ADVERSE EVENT RECEIVED FOR DISLOCATION OF THE REVERSED SHOULDER PROSTHESIS. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO DEVICE. EVENT IS NOT RELATED TO PROCEDURE. DATE OF IMPLANT: (B)(6) 2023. DATE OF REVISION: (B)(6) 2023. DATE OF EVENT: 08 NOV 2023. (RIGHT SHOULDER). TREATMENT: REVISION; GLENOSPHERE WAS REVISED.

  Patient problems: Joint Dislocation

  MAUDE report 18208963 ↗
• InjuryNov 21, 2023Fracture; Device Dislodged or Dislocated; Fracture; Device Dislodged or Dislocated

  ADDITIONAL INFORMATION RECEIVED: A. PLEASE CLARIFY, WAS THE GLENOSPHERE FRACTURED? NO. B. WAS THERE ANY SUGGESTION BY ANYONE INDICATING THAT THERE WAS OR MAY BE A DEFICIENCY WITH THE DXTEND SCREW LOCK D4.5X36MM? IF YES, PLEASE PROVIDE DETAILS. POSSIBLY WASN'T SEATED ALL THE WAY.

  Patient problems: Joint Dislocation

  MAUDE report 18182566 ↗
• InjuryJun 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION REVERSE TOTAL SHOULDER REPLACEMENT. PATIENT PRESENTED TO SURGEON WITH A PAINFUL SHOULDER. DECISION WAS MADE TO REVISE THE SHOULDER DUE TO INFERIOR NOTCHING. THE REVISION SURGERY WAS UNDERTAKEN AND THE GLENOSPHERE WAS REMOVED AND REPLACED WITH A LATERALISED GLENOSPHERE. THE POLY LINER WAS REMOVED AND REPLACED WITH A NEW POLY LINER. RANGE OF MOTION WAS PERFORMED AND NO IMPINGEMENT WAS NOTED. DOI: UNKNOWN, DOE: (B)(6) 2023, AFFECTED SIDE: UNKNOWN.

  Patient problems: Pain; Unspecified Tissue Injury

  MAUDE report 17207945 ↗
• InjuryFeb 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT PRESENTED WITH INFECTION. SURGEON REMOVED IMPLANTS TO PLACE ANTIBIOTIC SPACER. NOT ABLE TO READ ANY LOT NUMBERS. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Unspecified Infection

  MAUDE report 16434557 ↗
• MalfunctionOct 12, 2022Fracture; Fracture

  IT WAS REPORTED THAT THE GLENOSPHERE THREAD BROKEN 2X.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15587307 ↗
• InjuryJun 22, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  LEFT SHOULDER REPLACEMENT REVISION FOR DISLOCATION - SURGEON NOTED THAT IN PRIMARY SHOULDER (COMPLETED BY HIM (B)(6) 2022) THE METAGLENE HAS BEEN POSITIONED QUITE HIGH ON THE FACE OF THE GLENOID, CAUSING THE HUMERAL CUP TO NOTCH ON THE INFERIOR NECK OF GLENOID. SURGEON REMOVED GLENOSPHERE AND HUMERAL CUP, REMOVED EXTRA BONE FROM NECK OF GLENOID AND REPLACED THE GLENOSPHERE AS WELL AS ADDING A RETENTIVE CUP DOI: (B)(6) 2022. DOR: (B)(6) 2022. LEFT SHOULDER.

  Patient problems: Joint Dislocation; Unspecified Tissue Injury

  MAUDE report 14773036 ↗
• 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 14381519 ↗
• InjuryApr 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO LOOSENING OF THE METAGLENE AT THE BONE TO IMPLANT INTERFACE. IT WAS ALSO REPORTED THAT THE 12 YEAR OLD DELTA REVERSE BECAME UNSTABLE, POLY WEAR IS PRESENT, AND THIS IS A GLENOID DEFECT. PATIENT CONVERTED INTO A CTA, STEM WAS WELL FIXED. DOI- UNKNOWN, DOR- (B)(6) 2022, AFFECTED SIDE- LEFT SHOULDER.

  Patient problems: Joint Laxity

  MAUDE report 14136990 ↗
• InjuryJan 31, 2022Fracture; Migration; Fracture; Migration

  THE GLENOSPHERE SCREWING SYSTEM HAD BROKEN RESULTING IN MEDIALIZATION OF THE IMPLANT CAUSING PAIN FOR THE PATIENT AS WELL AS A DECREASE IN SHOULDER MOBILITY. A REVISION HAS BEEN MADE FOR A REPLACEMENT OF PROSTHESIS ON (B)(6) 2022. THE DEVICE WAS IMPLANTED ON 2018. DOI: 2018, DOR: (B)(6) 2022, UNKNOWN SHOULDER.

  Patient problems: Loss of Range of Motion; Pain

  MAUDE report 13392580 ↗
• InjuryDec 30, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE INFECTION WAS CONFIRMED.

  Patient problems: Inflammation; Pain; Unspecified Infection

  MAUDE report 13117862 ↗
• InjuryNov 16, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED DUE TO LOOSENING OF THE UNKNOWN COMPONENT AT BONE TO IMPLANT INTERFACE. PATIENT DISLOCATED HIS REVERSE LTSA MANY MONTHS AGO AND NEVER CAME BACK FOR SURGERY AFTER BEING SEEN IN CLINIC AND WAS TOLD TO COME BACK FOR SURGERY. PATIENT FINALLY SHOWS UP IN CLINIC OVER TWO YEARS LATER AND X-RAYS REVEALS THAT THE METAGLENE, FOUR SCREWS AND GLENOSPHERE HAD DETACHED FROM THE GLENOID AND WAS FREE FLOATING IN THE SHOULDER. REMOVED AND CONVERTED TO A CTA. DOI: (B)(6) 2019. DOR: (B)(6) 2021. UNKNOWN SHOULDER SIDE.

  Patient problems: Joint Dislocation

  MAUDE report 12820439 ↗
• InjuryMay 3, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INSTABILITY. DOI: (B)(6) 2019 DOR: (B)(6) 2021 LEFT SHOULDER.

  Patient problems: Joint Laxity

  MAUDE report 11761726 ↗
• InjuryApr 13, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A DEPUY SYNTHES SALES CONSULTANT WAS NOTIFIED PRIOR TO THE CASE BY A SURGEON THAT THE PATIENT HAD FALLEN THE PREVIOUS WEEK AND RE-INJURED THE OPERATIVE SHOULDER. SURGEON ADVISED THAT HE PLANNED TO REVISE THE PATIENT'S INJURED SHOULDER AND TREAT FOR POSSIBLE INFECTION. UPON FURTHER INTRAOPERATIVE EVALUATION, SURGEON DISCOVERED THAT THE METAGLENE, 4 LOCKING SCREWS AND THE GLENOSPHERE HAD ALL BECOME DISLODGED FROM THE PATIENT'S GLENOID. SURGEON WAS ABLE TO EXTRACT ALL OF THESE IMPLANTS AS ON UNIT COMPLETELY PUT TOGETHER AND UNDAMAGED. AT THIS POINT, SURGEON CHECKED THE HUMERAL STEM AND EPIPHYSIS WAS DETERMINED THAT THOSE IMPLANTS REMAINED WELL FIXED AND UNDAMAGED. SURGEON REPLACED THE HUMERAL CUP POLY AND FORMED AN ANTIBIOTIC CEMENT SPACER TO SERVE AS A TEMPORARY FIT PROSTHESIS WHILE THE PATIENT'S INFECTION WILL BE TREATED. DUE TO QUESTIONS ABOUT THE STABILITY AND HEALTH OF THE PATIENT'S GLENOID, SURGEON ASKED FOR ASSISTANCE FROM THE DEPUY SYNTHES TRUMATCH SHOULDER SOLUTIONS TEAM TO EVALUATE OPTIONS AND RECOMMENDATIONS FOR THE PATIENT'S GLENOID FOLLOWING TREATMENT OF THE INFECTION. DOI: (B)(6) 2017 DOR: (B)(6) 2021 LEFT SHOULDER.

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

  MAUDE report 11659416 ↗
• InjuryApr 5, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT SHOULDER WAS REVISED TO ADDRESS DISLOCATION FROM REVERSE TSA, AFTER WORKING WITH HIS HORSES. WAS REVISED FROM A +0 TO +2 GLENOSPHERE AND A +6 TO +9 POLY. NO DELAY IN SURGERY. DOI: UNKNOWN, DOR: (B)(6) 2021, RIGHT SHOULDER.

  Patient problems: Joint Dislocation

  MAUDE report 11613125 ↗
• InjuryMar 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION. DOI: (B)(6) 2017; DOR: (B)(6) 2021; LEFT SHOULDER.

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

  MAUDE report 11497615 ↗
• 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 11486218 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K062250, K120174, 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
• 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-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-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-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-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.
• 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.