DELTA XTEND 2307-87-005Recalls & reported problems

Summary

The FDA's MAUDE database contains 106 adverse event reports that list this exact device (DI 10603295116462), received between Aug 23, 2017 and Aug 6, 2026 — classified as 1 injury, 105 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (67 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 106 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 6, 2026Device-Device Incompatibility

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50164846 ↗
• MalfunctionJun 8, 2026Material Deformation

  IT WAS REPORTED THAT DURING A SHOULDER REPAIR SURGERY, THE GREEN DISK WAS BROKEN AND THROWN AWAY AFTER THE CASE. THE BLUE HANDLE SCREWDRIVER WAS STRIPPED. THE HUMERAL CUPS WERE ALSO BROKEN AND THROWN AWAY AFTER THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25429353 ↗
• MalfunctionJun 8, 2026Material Deformation

  IT WAS REPORTED THAT DURING A SHOULDER REPAIR SURGERY, THE GREEN DISK WAS BROKEN AND THROWN AWAY AFTER THE CASE. THE BLUE HANDLE SCREWDRIVER WAS STRIPPED. THE HUMERAL CUPS WERE ALSO BROKEN AND THROWN AWAY AFTER THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25428248 ↗
• MalfunctionJun 1, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, THE METAGLENE INNER COMPONENT COULD NOT BE PROPERLY SCREWED INTO THE HANDLE. CONSEQUENTLY, NEITHER THE TEMPLATE NOR, SUBSEQUENTLY, THE METAGLENE IMPLANT ITSELF COULD BE SECURED FOR PROPER POSITIONING AND IMPLANTATION. THIS RESULTED IN DELAYS TO THE SURGICAL PROCEDURE, THOUGH IT CAUSED NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25350790 ↗
• MalfunctionMay 13, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT DURING PRE-SURGERY TESTING IT WAS OBSERVED THAT THE METAGLENE HOLDER DEVICE WOULD NOT PROPERLY GRIP THE TARGET AND THE IMPLANT, CAUSING THEM TO HANG LOOSELY ON THE INSTRUMENT SET OR FALL OFF. IT WAS REPORTED THAT THERE WAS NO DELAY IN THE PROCEDURE DUE TO THE EVENT. IT WAS REPORTED THAT THERE WAS NO HARM TO THE PATIENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25159774 ↗
• MalfunctionFeb 5, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT THE BLUE HANDLE WOULD NOT HOLD THE METAGLENE OR IMPLANT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24272383 ↗
• MalfunctionFeb 5, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT THE HANDLE WILL NOT HOLD ON OR CONNECT CORRECTLY WITH METAGLENE GUIDE OR METAGLENE IMPLANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24270616 ↗
• MalfunctionDec 11, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THIS DURING A REVERSE SHOULDER ARTHROPLASTY (RSA) PERFORMED, THE USER ATTEMPTED TO ATTACH THE METAGLENE POSITIONING PLATE TO THE METAGLENE HOLDER, BUT IT DID NOT FIT THROUGH THE HOLE IN THE PLATE AND COULD NOT BE USED. IT WAS NOTED THAT ADDITIONAL ATTEMPTS WERE MADE TO FIT THE PLATE AND HOLDER BUT WERE UNABLE TO GET IT INTO THE HOLE IN THE PLATE. THEREFORE, IT WAS NOT POSSIBLE TO FIX THE METAGLENE. USING THE HOSPITAL'S EQUIPMENT, THE SURGEON MANAGED TO PLACE THE GUIDE PIN AND INSERT THE METAGLENE, COMPLETING THE 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 23783944 ↗
• MalfunctionNov 5, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE MOUNTING FOR THE METAGLENE DOES NOT REALLY WORK ANYMORE, ALTHOUGH THEY GOT COMPLETELY NEW SIEVES ABOUT 6 MONTHS AGO. IT NO LONGER GRIPS THE BASE PLATE AND IT CONSTANTLY DROPS OFF, INCLUDING THE IMPLANT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23480592 ↗
• MalfunctionOct 9, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT THE MODULE WAS OPENED IN THE STERILE UNIT AND STAFF REMOVED THE PLASTIC FROM THE MODULE. THEY OPENED THE CONTAINER AND TOOK OUT ALL LEVELS TO INSPECT THEM BEFORE WASHING THEM IN THE DISHWASHER. THEY FOUND BLOOD AND TISSUE ON 5 PLACES. THEY ALSO FOUND THAT THE CANNULATED PARTS HAD A BLACK COATING INSIDE THEM. THEY REMOVED THE TISSUE PIECES AND WASH THE INSTRUMENTS AND TRAYS IN THE DISHWASHER. THE BLACK COATING REMAINED AFTER THE FIRST WASH. THEY WASHED THESE INSTRUMENTS AGAIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23256019 ↗
• MalfunctionJun 5, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT PATIENT UNDERWENT ARTHROPLASTY ON (B)(6) 2025. THE BLUE METAGLENE HOLDER TIP WAS DAMAGED AND WAS UNABLE TO BE INSERTED INTO THE METAGLENE POSITIONER PLATE. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22149628 ↗
• MalfunctionMay 23, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE RIGHT REVERSE TSA, AFTER CASE IT WAS NOTED, THE HANDLE CAME OFF THE TIGHTENING ROD. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED FOR REPORTING. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22080591 ↗
• MalfunctionMay 17, 2025Break; Break

  IT WAS REPORTED THAT BEFORE THE CASE THAT THE METAGLENE HOLDER WAS BROKEN. ANOTHER METAGLENE HOLDER WAS LOCATED AND USED. THERE WAS NO NEGATIVE IMPACT TO THE CASE, NOR WAS THERE A DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22041136 ↗
• MalfunctionMay 16, 2025Break; Break

  ADDITIONAL INFORMATION WAS RECEIVED AND STATES THAT, AS IT WAS FOUND DURING THE VISUAL EXAMINATION PERFORMED ON THAT THE SHAFT HAS FALLEN APART STILL ATTACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22035449 ↗
• MalfunctionMay 1, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT SCREW DRIVER WILL NOT THREAD ONTO BASEPLATE.

  Patient problems: Insufficient Information

  MAUDE report 21945831 ↗
• MalfunctionMay 1, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT SCREW DRIVER WILL NOT THREAD ONTO BASEPLATE.

  Patient problems: Insufficient Information

  MAUDE report 21945826 ↗
• MalfunctionApr 2, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE METAGLENE HOLDER AND INTERNAL ROD NOT HOLDING ONTO METAGLENE POSITIONING PLATES. THERE WAS A 4 MINUTES OF SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21752707 ↗
• MalfunctionFeb 20, 2025Device-Device Incompatibility; Unintended Movement; Device-Device Incompatibility; Unintended Movement

  IT WAS REPORTED THAT INTRAOPERATIVELY THERE WERE DIFFICULTIES ATTACHING THE METAGLENE TEMPLATE WITH THE INSTRUMENT´S BLUE HANDLE. IT KEPT COMING LOOSE. THERE WAS NO SURGICAL DELAY, AND NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21423200 ↗
• MalfunctionFeb 19, 2025Structural Problem; Unintended Movement; Structural Problem; Unintended Movement

  IT WAS REPORTED THAT THE BLUE SCREWDRIVER INNER DRIVER PLASTIC HAS COME LOOSE AND WOULDN'T LOCK ON TO METAGLENE POSITIONING PLATE. THERE WAS NO SURGICAL DELAY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21411629 ↗
• MalfunctionJan 3, 2025Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  IT WAS REPORTED THAT THE HANDLE IS BROKEN AND WILL NOT CONNECT TO GUIDE. UNKNOWN SURGICAL DELAY.

  Patient problems: Insufficient Information

  MAUDE report 21066836 ↗
• MalfunctionNov 21, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING THE SET UP PROCESS IT WAS DETERMINED THAT THE TIP OF THE INSERTION HANDLE WOULD NOT PROPERLY FIT INSIDE THE PIN GUIDE. ANOTHER SET OF INSTRUMENTS WAS OPENED AND USED. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20746550 ↗
• MalfunctionOct 15, 2024Device-Device Incompatibility; Unintended Movement; Device-Device Incompatibility; Unintended Movement

  IT WAS REPORTED THAT THE SURGEON WAS DOING A DELTA XTEND REVERSE SHOULDER REPLACEMENT TODAY AND REPORTED THAT THE METAGLENE HOLDER AND METAGLENE HOLDER INTERNAL ROD WERE NOT HOLDING THE METAGLENE GUIDE PLATE EFFECTIVELY AS IT WAS LOOSE. ALSO, THE SIZE 38 GLENOSPHERE TRIAL WAS DAMAGED BY INSTRUMENTS AND MISUSE. THE PLASTIC WAS SCRATCHED AND SHREDDED ON THE INNER ASPECT OF THE GLENOSPHERE. THERE WAS MINIMAL DELAY TO THE SURGERY WHILST REATTACHING METAGLENE PLATE. THERE WAS NO KNOW PATIENT ADVERSE EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20451671 ↗
• MalfunctionAug 29, 2024Device-Device Incompatibility; Material Deformation; Naturally Worn; Device-Device Incompatibility; Material Deformation; Naturally Worn

  ADDITIONAL INFORMATION RECEIVED AND STATING THAT: A. WHAT DO YOU MEAN BY DAMAGE? WAS IT BROKEN INTO TWO OR MORE PIECES, CRACKED, BENT OR ANY OTHER DEFICIENCY WITH THE DEVICE THAT WAS NOT FUNCTION AS INTENDED? - WORN B. WAS THERE A SURGICAL DELAY IN RELATION TO THE REPORTED EVENT? - NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20100624 ↗
• MalfunctionAug 26, 2024Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  IT WAS REPORTED THAT THE METAGLENE HOLDER WAS BROKEN AND NOT THREADING IN TOGETHER. THE PRODUCT DAMAGE DOCUMENTED IN THIS PC HAS BEEN IDENTIFIED DURING LOAN KIT INSPECTION, BY THE LOAN KIT TECHNICIAN. THE EVENT DATE AND ALERT DATE ARE THE DATE THAT THE INSPECTION TOOK PLACE. THERE IS NO SURGEON, PROCEDURE, OR PATIENT DETAILS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20064023 ↗
• MalfunctionAug 15, 2024Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  IT WAS REPORTED THAT THE BLUE SCREW DRIVER WAS NOT HOLDING GUIDE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19994385 ↗