DELTA XTEND 1307-61-138Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10603295502555), received between Jan 28, 2021 and May 27, 2026 — classified as 8 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Difficult to Insert” (8 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 27, 2026Difficult to Insert

  IT WAS REPORTED THE GLENOSPHERE COULD NOT BE IMPLANTED. THERE WAS AN ISSUE WITH THE SCREW ART. SURGERY WAS DELAYED 15 MINUTES. A NEW GLENOSPHERE WAS USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25304500 ↗
• InjuryJan 23, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO LOOSENING OF SHOULDER. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Joint Laxity

  MAUDE report 24162153 ↗
• InjuryAug 19, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT UNFORTUNATELY THE PATIENT DISLOCATED AGAIN. THE DOCTOR FELT THE PATIENT WOULD BENEFIT FROM A CHANGE OF THE POLY AND GLENOSPHERE. THE DOCTOR CHANGED THE 38+0 GLENOSPHERE TO A 42+6 GLENOSPHERE. THEN A 42+6 RETENTIVE POLY WAS TRIALED AND FOUND TO BE STABLE. THE REAL POLY WAS OPENED AND IMPLANTED AND STABILITY WAS CONFIRMED. NO ADDITIONAL DELAYS OR ADVERSE EVENTS TOOK PLACE. CLOSING PROCESS BEGAN.

  Patient problems: Joint Dislocation

  MAUDE report 22840745 ↗
• InjurySep 6, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE RIGHT SHOULDER PAIN OVER LAST SEVERAL MONTHS. PATIENT HAD A REVERSE SHOULDER IMPLANTED ABOUT 10 YEARS AGO. GLENOSPHERE DISSOCIATED FROM BASE PLATE. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Pain

  MAUDE report 20157793 ↗
• MalfunctionMar 12, 2024Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT DELTA EXTEND GLENOSPHERE WOULD NOT SCREW INTO METAGLENES. THE STAR 20 SCREW DRIVER GOT STUCK INTO CENTRAL POST. DOE: ON (B)(6) 2024 AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Insufficient Information

  MAUDE report 18884477 ↗
• MalfunctionJan 2, 2024Difficult to Insert; Difficult to Insert

  IN A CASE THIS AFTERNOON THE UPPER LIMB SURGEON WAS UNABLE TO SCREW IN THE LATERALISED GLENOSPHERE + 0MM 38MM STANDARD TO THE METAGLENE BASE PLATE. HE ADVISED THAT THE SCREWS SIMPLY WOULD NOT ENGAGE. HE THEN OPTED TO IMPLANT A 38MM ECCENTRIC GLENOSPHERE WHICH HE WAS ABLE TO SCREW INTO THE METAGLENE BASE PLATE.

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

  MAUDE report 18424956 ↗
• MalfunctionNov 13, 2023Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT UPON SCREWING THE GLENOSPHERE INTO THE COLLET AND METAGLENE, THE SURGEON GOT THE TACTILE FEEL THAT THE SCREW WOULD TIGHTEN AND THEN ONCE IT REACHED A CERTAIN TIGHTNESS WOULD RELEASE AND FEEL AS IF NOT THREADED AT ALL. SURGICAL DELAY UNKNOWN. DOE: (B)(6) 2023. AFFECTED SIDE: UNKNOWN SHOULDER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18118375 ↗
• MalfunctionSep 28, 2023Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE SURGEON TRIED TO PUT IN A NEW GLENOSHERE 38+0 STANDARD BUT COULD NEVER GET THE THREADS TO ENGAGE. SURGEON TRIED IT FOR OVER 20 MINUTES. SURGEON PUT IN THE OLD GLENOSHERE AND IT WENT RIGHT IN THE FIRST TIME THREADS ENGAGED. THERE WAS NO DAMAGE ON THE THREADS OF THE NEW ONE THAT WOULD NOT GO IN AND DID NOT KNOW WHY THE THREADS DID NOT ENGAGE. DOE: (B)(6) 2023. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Insufficient Information

  MAUDE report 17832719 ↗
• InjurySep 14, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE SURGEON BELIEVED THE PATIENT HAD A FALL AND DISLOCATED HER SHOULDER. HE DECIDED TO REMOVE THE CURRENT CUP AND REPLACE WITH A THICKER ONE FOR STABILITY. TIME WAS NOT DELAYED AND NOTHING SEEMED TO BE WRONG WITH ANY OF OUR IMPLANTS. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Joint Dislocation

  MAUDE report 17743692 ↗
• InjuryAug 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD HER SHOULDER REPLACED APPROPRIATELY A YEAR AGO BY THE SURGEON WHERE A DELTA RSA CONSTRUCT WAS USED. SHE DID WELL FOR A FEW MONTHS AND BEGAN EXPERIENCING SOME PAIN AND DISCOMFORT IN HER SHOULDER. THE DECISION WAS MADE TO REVISE HER SHOULDER WITH THE SUSPICION OF INFECTION AND A LOOSE COMPONENT. DURING THE REVISION SURGERY, THE METAGLENE COMPONENT WITH THE SCREWS WERE FOUND TO BE LOOSE. CULTURES WERE TAKEN FOR TESTING FOR INFECTION WHICH THE SURGEON IS SUSPICIOUS OF. THE LAB RESULTS ARE NOT AVAILABLE TO CONFIRM IF AN INFECTION IS PRESENT. THE METAGLENE, 4 SCREWS, GLENOSPHERE, AND HUMERAL POLY WERE EXPLANTED AND A DELTA CTA HUMERAL HEAD WAS IMPLANTED ON THE EPIPHYSYS AND STEM THAT WAS LEFT IN SITU. THIS PATIENT NOW HAS A HEMI CONSTRUCT. THE CAT # AND LOT # WERE UNABLE TO BE RECORDED. IT WAS UNKNOWN IF THERE WAS ANY SURGICAL DELAY. THE LOOSENING INTERFACE AND CEMENT MANUFACTURER WERE UNKNOWN. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT SHOULDER.

  Patient problems: Discomfort; Pain; Unspecified Infection

  MAUDE report 17583764 ↗
• InjuryMar 13, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ADDITIONAL INFORMATION RECEIVED INDICATES THAT THERE WAS NO SURGICAL DELAY.

  Patient problems: Joint Dislocation

  MAUDE report 16529007 ↗
• MalfunctionSep 8, 2022Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE GLENOSPHERE WOULD NOT SEAT ONTO METAGLENE. THERE WAS NO LOOSENING. THERE WAS SURGICAL DELAY OF 1 HOUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15380191 ↗
• InjuryAug 17, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT REMOVAL OF GLENOSPHERE, POLY AND EPI WAS PERFORMED DUE TO DISLOCATION. CHANGED VERSION WITH IMPLANTING NEW IMPLANTS. NOTHING MORE TO REPORT. DOI: (B)(6) 2022; DOR: (B)(6) 2022; AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Joint Dislocation

  MAUDE report 15239709 ↗
• MalfunctionNov 23, 2021Difficult to Insert; Device Damaged Prior to Use; Difficult to Insert; Device Damaged Prior to Use

  SURGEON HAD TROUBLE GETTING GLENOSPHERE IMPLANT (1307-61-138) TO ENGAGE IN METAGLENE. HE TRIED TO GET THE IMPLANT SEATED AND THREAD DOWN THE SCREW BUT IT WOULDN'T ENGAGE. EVENTUALLY HE PULLED OUT THE IMPLANT AND FOUND THE THREADS HAD BEEN DAMAGED. HE ENDED UP IMPLANTING THE ORIGINAL GLENOSPHERE VERSION (1307-60-138) AND SUGGESTED THAT THE LONGER THREADS ON THAT VERSION MAY HAVE HELPED IT TO ENGAGE. THIS WAS VERY SIMILAR TO WHAT HAPPENED IN THE LAST REVERSE SHOULDER CASE HE DID. HE SUGGESTED ALSO THAT THE SHOULDER WAS VERY SMALL AND DIFFICULT TO EXPOSE. SEE (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12863379 ↗
• MalfunctionMar 9, 2021Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE END OF THE GLENOSPHERE THREADS EASILY STRIPPED AND WERE NOT ABLE TO INTRODUCE INTO THE METAGLENE AND ENGAGE. THIS WAS DUE TO KNOW ERROR OF THE SURGEON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11445747 ↗
• InjuryJan 28, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT WAS REVISED TO ADDRESS DISLOCATION. MECHANISM UNKNOWN. DOI: (B)(6) 2020, DOR: (B)(6) 2021, LEFT SHOULDER.

  Patient problems: Joint Dislocation

  MAUDE report 11243827 ↗