DELTA XTEND 1307-64-138Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 10603295502456), received between Nov 8, 2019 and Sep 21, 2026 — classified as 14 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Difficult to Insert” (9 reports).

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 18, 2026.

Most reported problems

Recent adverse event reports

The 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 21, 2026Difficult to Insert

  It was reported that intraoperatively it was not possible to fix both glenospheres in the metaglene. Another glenosphere and another metaglene were used, and the surgery was completed. The surgical delay was about 30 minutes. All available information has been disclosed.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50841570 ↗
• MalfunctionSep 21, 2026Difficult to Insert

  It was reported that intraoperatively it was not possible to fix both glenospheres in the metaglene. Another glenosphere and another metaglene were used, and the surgery was completed. The surgical delay was about 30 minutes. All available information has been disclosed.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50841567 ↗
• InjuryOct 15, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO DISLOCATION. DOI: (B)(6) 2024, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Joint Dislocation

  MAUDE report 23296194 ↗
• InjuryMar 24, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DISLOCATION RIGHT SHOULDER FOLLOWING IMPLANTATION OF REVERSE TOTAL SHOULDER. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Joint Dislocation

  MAUDE report 21677693 ↗
• 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 21306988 ↗
• InjuryDec 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE GLENOID HAD LOOSENED, THERE WAS BROKEN 36MM LOCKING SCREW. THE PATIENT HAD A SUSPECTED INFECTION. UNKNOWN SURGICAL DELAY. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Unspecified Infection

  MAUDE report 20914828 ↗
• InjuryOct 14, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED PATIENT LEFT SHOULDER WAS REVISED POLY FOR DISLOCATION ON (B)(6) 2024. DATE OF IMPLANT IS UNKNOWN.

  Patient problems: Joint Dislocation

  MAUDE report 20438846 ↗
• InjuryJul 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED: A. WHAT WAS THE PRIMARY REASON FOR REVISION? WAS IT PAIN OR INFECTION OR INSTABILITY? B. WAS THE PATIENT REVISED FOR PAIN AND INFECTION FOUND UPON REVISION? OR INFECTION WAS FOUND EARLIER? "IT WAS REVISED FOR PAIN AND FOUND INTRAOPERATIVELY TO BE GROSSLY INFECTED."

  Patient problems: Joint Laxity; Pain; Unspecified Infection

  MAUDE report 19781839 ↗
• 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: ON (B)(6) 2023, DOR: ON (B)(6) 2024, AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Unspecified Infection

  MAUDE report 19446612 ↗
• InjurySep 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INSTABILITY. THE GLENOSPHERE AND POLY INSERT WERE REMOVED AND LARGER SIZES WERE USED. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: UNKNOWN.

  Patient problems: Joint Laxity

  MAUDE report 17743623 ↗
• InjuryJul 18, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE INITIAL SURGERY ON (B)(6) CONVERTED A UNITE ANATOMIC TSA TO A REVERSE TSA. THE PATIENT BECAME UNSTABLE AND DISLOCATED IN LAST FEW WEEKS. DURING REVISION IT WAS DISCOVERED THE EPI WAS NOT COMPLETELY LOCKED DOWN AND HAD ROTATED. SURGEON REMOVED ALL DEPUY COMPONENTS AND WENT BACK WITH ARTHREX WHICH HE USES REGULARLY. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Joint Dislocation; Joint Laxity

  MAUDE report 17343795 ↗
• InjuryMay 10, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT WAS REVISED DUE TO DISLOCATION OF A REVERSE TOTAL SHOULDER. UNKNOWN SURGICAL DELAY. DOI: (B)(6) 2023, DOR: (B)(6) 2023, AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Joint Dislocation

  MAUDE report 16902441 ↗
• MalfunctionDec 14, 2022Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT INTRAOPERATIVELY THE GLENOSPHERE WAS NOT POSSIBLE TO SCREW ONTO THE METAGLENE. THE GLENOSPHERE´S RECENTLY NEW DESIGNED SHORTER SCREW MADE IT DIFFICULT TO HANDLE. ANOTHER GLENOSHERE AVAILABLE AND SURGERY WAS COMPLETED AS INTENDED. SURGERY PROLONGATION ABOUT 5 MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15983782 ↗
• MalfunctionDec 6, 2022Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE COLLET AND THE GLENOSPHERE SCREW WOULD NOT PROPERLY ENGAGE. THE SCREW WOULD ONLY TURN BUT WILL NOT LOCK. NO SURGICAL DELAY IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15925096 ↗
• InjuryDec 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL NOTIFICATION RECEIVED FOR REVISION DUE TO PAIN AND STIFFNESS. DATE OF IMPLANT: ON (B)(6) 2022. DATE OF REVISION: ON (B)(6) 2022. (RIGHT SHOULDER). TREATMENT: CUP, GLENOSPHERE, AND EPIPHYSIS WERE REVISED. DEPUY PRODUCTS USED: CATALOG ID:130760000. LOT NUMBER/PRODUCT IDENTIFIER: 3630411. COMPONENT TYPE: METAGLENE. DESCRIPTION: DELTA XTEND METAGLENE STD. CATALOG ID: 130790030. LOT NUMBER/PRODUCT IDENTIFIER: 5393537. COMPONENT TYPE: SCREW. DESCRIPTION: DELTA XTEND LOCKING SCREW 4.5 X 30. CATALOG ID: 130790036. LOT NUMBER/PRODUCT IDENTIFIER: 5385561. COMPONENT TYPE: SCREW. DESCRIPTION: DELTA XTEND LOCKING SCREW 4.5 X 36. CATALOG ID: 130764138. LOT NUMBER/PRODUCT IDENTIFIER: D21081277. COMPONENT TYPE: GLENOSPHERE. DESCRIPTION: STANDARD GLENOSPHERE 38MM, +4MM LATERALIZATION. CATALOG ID: 110014100. LOT NUMBER/PRODUCT IDENTIFIER: 3650214. COMPONENT TYPE: STEM. DESCRIPTION: GLOBAL UNITE STD. STEM SZ 14. CATALOG ID: 130720113. LOT NUMBER/PRODUCT IDENTIFIER: 9704331. COMPONENT TYPE: EPIPHYSIS. DESCRIPTION: DELTA XTEND MODULAR ECCENTRIC 145 EPI POROCOAT SIZE 1 RIGHT. CATALOG ID: 130738206. LOT NUMBER/PRODUCT IDENTIFIER: 5381463. COMPONENT TYPE: SHELL. DESCRIPTION: DELTA XTEND HUMERAL C

  Patient problems: Muscular Rigidity; Pain

  MAUDE report 15892819 ↗
• InjuryAug 29, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT HAS HAD MULTIPLE OPERATIONS ON THE OPERATIVE SHOULDER, ALONG WITH AN INFECTION. THE PATIENT DISLOCATED HIS REVERSE SHOULDER SEVERAL TIMES POST OP. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2022. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Joint Dislocation; Joint Laxity; Unspecified Tissue Injury

  MAUDE report 15312223 ↗
• MalfunctionFeb 10, 2021Difficult to Insert; Difficult to Insert

  INTRAOPERATIVELY DURING A PRIMARY SHOULDER-TEP RIGHT SIDE IT WAS NOT POSSIBLE TO CONNECT THE GLENOSPHERE TO METAGLENE. NO SURGICAL, NO ADVERSE PATIENT CONSEQUENCES. PROCEDURE WAS FINISHED SUCCESSFULLY AS ANOTHER GLENOSPHERE WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11311242 ↗
• InjurySep 29, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ADDITIONAL INFORMATION RECEIVED STATES THAT SURGEON FELT THAT HE COULD NOT GET THE PATIENTS SHOULDER STABLE ENOUGH TO NOT DISLOCATE AGAIN. THERE WAS SIGNIFICANT BONE LOSS ON THE GLENOID BEFORE THE INITIAL SURGERY. HE FELT IT WAS BEST IN THE LONG RUN TO REMOVE THE HEAD AND METAGLENE AND PUT IN A CTA HEAD HEMI-ARTHROPLASTY .

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 10601105 ↗
• MalfunctionFeb 19, 2020Difficult to Insert; Device-Device Incompatibility; Difficult to Insert; Device-Device Incompatibility

  IT WAS REPORTED THAT THE LATERALIZED GLENOID WAS NOT ENGAGING INTO BASEPLATE. DOE: (B)(6) 2020; LEFT SHOULDER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9728839 ↗
• MalfunctionJan 2, 2020Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT GLENOSPHERE THREADS WOULD NOT ENGAGE INTO THE METAGLENE. WASTE 3 GLENOSPHERE UNTIL THE METAGLENE WAS REVISED. THREADS APPEARED TO BE DAMAGED. SURGEON SUGGESTED THAT PERHAPS THE THREADS IN THE METAGLENE WERE NOT SPEC. 30 MINUTES OF SURGICAL DELAY.

  Patient problems: Not Applicable

  MAUDE report 9538901 ↗
• MalfunctionJan 2, 2020Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT GLENOSPHERE THREADS WOULD NOT ENGAGE INTO THE METAGLENE. WASTE 3 GLENOSPHERE UNTIL THE METAGLENE WAS REVISED. THREADS APPEARED TO BE DAMAGED. SURGEON SUGGESTED THAT PERHAPS THE THREADS IN THE METAGLENE WERE NOT SPEC. 30 MINUTES OF SURGICAL DELAY.

  Patient problems: Not Applicable

  MAUDE report 9538898 ↗
• MalfunctionNov 26, 2019Difficult to Insert; Inadequacy of Device Shape and/or Size; Difficult to Insert; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT THE GLENOSPHERE 38+4 IS NOT ENGAGING INTO METAGLENE BASE PLATE. THE SURGEON DOES NOT EXPRESS MUCH CONCERN ABOUT MECHANISM NOT ENGAGING PROPERLY. DOE: (B)(6) 2019.

  Patient problems: Not Applicable

  MAUDE report 9378988 ↗
• InjuryNov 8, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED TO ADDRESS DISLOCATION. DOI: (B)(6) 2019, DOR: (B)(6) 2019 UNKNOWN SIDE.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 9296038 ↗