DELTA XTEND 1307-61-142Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 10603295502562), received between Sep 28, 2020 and Sep 25, 2026 — classified as 11 injuries, 16 malfunctions.

The most frequently reported specific device problem is “Difficult to Insert” (17 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 25 most recent of 27 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2026Difficult to Insert

  It was reported that during an unknown surgery the Glenosphere could not be impacted onto the metaglene. There was no reported patient or user harm. There was no significant delay. The affected side was left. All available information has been disclosed.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50897719 ↗
• InjuryJun 9, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD DISCOMFORT, REVISED THE GLENOSPHERE AND POLY. AFFECTED SIDE-UNKNOWN SHOULDER.

  Patient problems: Discomfort

  MAUDE report 25446744 ↗
• MalfunctionMay 22, 2026Difficult to Insert

  IT WAS REPORTED IT WAS NOT POSSIBLE TO SCREW THE GLENOSPHERE INTO THE METAGLENE. SCREW THREADS ARE DAMAGED. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A 10 MINUTE SURGICAL DELAY. DEVICE WAS CHANGED TO A 38 ECC. NO REPORTED PATIENT HARM.

  Patient problems: Insufficient Information

  MAUDE report 25254117 ↗
• InjuryMay 1, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REMOVAL OF ALL GLENOID IMPLANTS AND IMPLANTATION OF A CTA HEAD ONTO THE STEM DUE TO INFECTION. DOI-UNKNOWN. DOR- (B)(6) 2026. AFFECTED SIDE-RIGHT SHOULDER.

  Patient problems: Unspecified Infection

  MAUDE report 25059196 ↗
• MalfunctionFeb 18, 2026Difficult to Insert; Material Deformation

  IT WAS REPORTED THAT DURING A REVERSE SHOULDER ARTHROPLASTY ON THE RIGHT SHOULDER, WHILE THE SURGEON WAS IMPLANTING THE FIRST SIZE 42 STANDARD GLENOSPHERE, THE HEAD COULD NOT BE SEATED. WHEN THE DEVICE WAS PULLED OUT AFTER USE, IT WAS OBSERVED THAT THE THREADS WERE STRIPPED/DAMAGED. THE USER DID THIS 2 MORE TIMES WITH ANOTHER SIZE 42 STANDARD, AND THEN WITH A 42 ECCENTRIC. THE SURGERY TIME WAS EXTENDED BY ANOTHER HOUR AND A HALF DUE TO THE EVENT.

  Patient problems: Insufficient Information

  MAUDE report 24377799 ↗
• MalfunctionFeb 18, 2026Difficult to Insert; Material Deformation

  IT WAS REPORTED THAT DURING A REVERSE SHOULDER ARTHROPLASTY ON THE RIGHT SHOULDER, WHILE THE SURGEON WAS IMPLANTING THE FIRST SIZE 42 STANDARD GLENOSPHERE, THE HEAD COULD NOT BE SEATED. WHEN THE DEVICE WAS PULLED OUT AFTER USE, IT WAS OBSERVED THAT THE THREADS WERE STRIPPED/DAMAGED. THE USER DID THIS 2 MORE TIMES WITH ANOTHER SIZE 42 STANDARD, AND THEN WITH A 42 ECCENTRIC. THE SURGERY TIME WAS EXTENDED BY ANOTHER HOUR AND A HALF DUE TO THE EVENT.

  Patient problems: Insufficient Information

  MAUDE report 24377790 ↗
• InjuryFeb 10, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO INFECTION. SURGEON REMOVED ALL COMPONENTS AND INSERTED ANTIBIOTIC SPACER. DOI: (B)(6) 2025. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Unspecified Infection

  MAUDE report 24307545 ↗
• InjuryOct 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY NO: (B)(4). CLINICAL ADVERSE EVENT RECEIVED FOR REVISION ¿ INFECTION. DATE OF IMPLANT: (B)(6) 2025. DEVICE LOCATION: LEFT. TREATMENT/IMPACT: REVISION. COMPONENTS REMOVED: HEAD/GLENOSPHERE. DEPUY SYNTHES PRODUCTS USED: CATALOG NUMBER: 130761142. LOT NUMBER ID: D25041453. COMPONENT TYPE: GLENOSPHERE. DEVICE DESCRIPTION: STANDARD GLENOSPHERE 42MM, +0 LATERALIZATION.

  Patient problems: Unspecified Infection

  MAUDE report 23312655 ↗
• InjuryMay 16, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE GLENOSPHERE PEG BROKE OFF INTO METAGLENE. THE BROKEN PIECE WAS RETRIEVED. IMPLANTED NEW GLENOSPHERE AND METAGLENE. DOI: (B)(6) 2021. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Insufficient Information

  MAUDE report 22039044 ↗
• InjuryApr 22, 2025Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY FOR THE LEFT SHOULDER. INITIALLY THE PATIENT UNDERWENT REVERSE SHOULDER REPLACEMENT DUE TO A FRACTURED LEFT HUMERUS. A COUPLE OF WEEKS LATER THE PATIENT'S JOINT HAD DISLOCATED. THE GLENOSPHERE CHANGED AT THAT TIME TO LATERALIZED +0 MM 42MM STANDARD GLENOSPHERE; AND PE CUP 42+6MM. FOLLOWING THIS SECOND OPERATION, THE SURGICAL WOUND DEHISCED AND LOOKS INFECTED. THE PATIENT WENT BACK TO THEATRE AND HAD SPECIMENS TAKEN AND THE JOINT WASHED OUT. THE GLENOSPHERE AND CUP WERE REMOVED. NEW GLENOSPHERE 42MM AND STANDARD 42 +6MM PE CUP IMPLANTED.

  Patient problems: Unspecified Infection; Wound Dehiscence

  MAUDE report 21880811 ↗
• MalfunctionMar 18, 2025Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT INTRAOPERATIVELY IT HAD NOT BEEN POSSIBLE TO INSERT THE GLENOSPHERE. ANOTHER GLENOSPHERE WAS USED; ALSO WITH THIS ONE THE INSERTION WAS DIFFICULT, BUT IT WORKED. SURGICAL DELAY OF TWENTY-FIVE MINUTES; NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21631829 ↗
• MalfunctionJan 2, 2025Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT INTRAOPERATIVELY IT WAS NOT POSSIBLE TO ENGAGE THE GLENOSPHERE WITH THE METAGLENE. TWO GLENOSHERES DID NOT ENGAGED WITH THE METAGLENE. NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO SURGICAL DELAY WAS REPORTED. TO COMPLETE THE SURGERY A GLENOSPHERE 42+4 WAS IMPLANTED TOGETHER WITH THE INITIAL METAGLENE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21058217 ↗
• MalfunctionJan 2, 2025Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT INTRAOPERATIVELY IT WAS NOT POSSIBLE TO ENGAGE THE GLENOSPHERE WITH THE METAGLENE. TWO GLENOSHERES DID NOT ENGAGED WITH THE METAGLENE. NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO SURGICAL DELAY WAS REPORTED. TO COMPLETE THE SURGERY A GLENOSPHERE 42+4 WAS IMPLANTED TOGETHER WITH THE INITIAL METAGLENE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21058146 ↗
• MalfunctionDec 30, 2024Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT INTRAOPERATIVE IT WAS NOT POSSIBLE TO ENGAGE THREE GLENOSPHERE WITH THE METAGLENE. IN THE END THE METAGLENE WAS ALSO REPLACED, AS IT WAS IT WAS NOT CLEAR WHY THE CONNECTION HAD FAILED. NO ADVERSE PATIENT CONSEQUENCES REPORTED. TO COMPLETE THE SURGERY A GLENOSPHERE 42+4 WAS IMPLANTED. THERE WAS NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21044049 ↗
• MalfunctionDec 30, 2024Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT INTRAOPERATIVE IT WAS NOT POSSIBLE TO ENGAGE THREE GLENOSPHERE WITH THE THE METAGLENE. IN THE END THE METAGLENE WAS ALSO REPLACED, AS IT WAS IT WAS NOT CLEAR WHY THE CONNECTION HAD FAILED. NO ADVERSE PATIENT CONSEQUENCES REPORTED. TO COMPLETE THE SURGERY A GLENOSPHERE 42+4 WAS IMPLANTED. THERE WAS NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21044041 ↗
• MalfunctionDec 30, 2024Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT INTRAOPERATIVE IT WAS NOT POSSIBLE TO ENGAGE THREE GLENOSPHERE WITH THE THE METAGLENE. IN THE END THE METAGLENE WAS ALSO REPLACED, AS IT WAS IT WAS NOT CLEAR WHY THE CONNECTION HAD FAILED. NO ADVERSE PATIENT CONSEQUENCES REPORTED. TO COMPLETE THE SURGERY A GLENOSPHERE 42+4 WAS IMPLANTED. THERE WAS NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21044024 ↗
• InjuryDec 12, 2024Difficult to Insert; Device Dislodged or Dislocated; Difficult to Insert; Device Dislodged or Dislocated

  IT WAS REPORTED THAT GLENOSPHERE (SHORT SCREW) CANNOT BE IMPLANTED. THE GLENOSPHERE SCREW CANNOT BE IN METAGLENE HOLE. SHORT SCREW PREVENTS VIEW AND FEEL OPTION. SOFT TISSUE FOLD IS NOT VISIBLE. THE PATIENT EXPERIENCED LUXATION OF SHOULDER JOINT SAME DAY POST OP AND REQUIRED REVISION SURGERY.

  Patient problems: Joint Dislocation

  MAUDE report 20914219 ↗
• MalfunctionDec 6, 2024Difficult to Insert; Difficult to Insert

  PATIENT UNDERWENT ARTHROPLASTY ON (B)(6) 2024. SURGEONS COMMENT: "CLEAR DETERIORATION WITH SHORTER CENTRAL SCREWS IN THE GLENOSPHERE. LONGER SCREWS MADE IT EASIER TO FIND THE CENTRAL HOLE IN THE METAGLENE PLATE. YOU COULD SEE THE SCREW TIP. SHORTER SCREW MAKE THE GLENOSPHERE OBSCURE SO YOU CAN'T SEE THE END OF THE SCREW. IN ADDITION, SHORTER SCREW CONTROL THE GLENOSPHERE LESS WELL, WHICH MAKES IT EASY TO GET A LITTLE CROOKED (HARDER TO ALIGN) AGAINST METAGLENE." THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: Insufficient Information

  MAUDE report 20867095 ↗
• InjuryMar 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A DEPUY SYNTHES IMPLANT WAS REVISED AND REVIEWED FOR ANALYSIS REASON FOR REVISION: INSTABILITY & PAIN.

  Patient problems: Joint Laxity; Pain

  MAUDE report 18961862 ↗
• MalfunctionMar 15, 2024Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT DURING SURGERY, THE SURGEON WAS UNABLE TO ENGAGE THE SCREW OF THE GLENOSPHERE DEVICE INTO THE METAGLENE, SO OPENED A 2ND GLENOSPHERE DEVICE AND IMPLANTED WITH NO FURTHER ISSUE OR COMPLAINT.

  Patient problems: Insufficient Information

  MAUDE report 18911564 ↗
• InjuryDec 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Unspecified Infection

  MAUDE report 18371599 ↗
• MalfunctionAug 10, 2023Difficult to Insert; Difficult to Insert

  ADDITIONAL INFORMATION RECEIVED. INDICATES, THAT THE SCREW DID NOT ENGAGE THE THREAD. AND SO, COULD NOT BE SCREWED IN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17502521 ↗
• InjuryNov 17, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT'S SHOULDER WAS REVISED DUE TO INSTABILITY. THERE WAS NO LOOSENING AND NO DELAY IN SURGERY REPORTED. DOI: (B)(6) 2021; DOR: (B)(6) 2021; RIGHT SHOULDER.

  Patient problems: Joint Laxity

  MAUDE report 12827983 ↗
• MalfunctionOct 8, 2021Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT AFTER SEVERAL ATTEMPTS, SURGEON COULD NOT ENGAGE THE GLENOSPHERE TO THE METAGLENE BASE PLATE - WE OPENED ANOTHER IMPLANT AND WASTED THIS ONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12598705 ↗
• InjuryDec 22, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT WAS REVISED TO ADDRESS SHOULDER DISLOCATION. REASON FOR DISLOCATION IS UNDETERMINED AS PER SURGEON. NO DELAY TO SURGERY REPORTED. NO ADDITIONAL INFORMATION AVAILABLE. DOI: (B)(6) 2020, DOR: (B)(6) 2020, LEFT SHOULDER.

  Patient problems: Joint Dislocation

  MAUDE report 11057504 ↗