DELTA XTEND 2307-42-403Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10603295115885), received between Oct 25, 2018 and Dec 13, 2023 — classified as 1 injury, 8 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 13, 2023Break; Crack; Break; Crack

  IT WAS REPORTED THAT THE POLY TRIAL WAS CRACKED AND ENDED UP BREAKING NO PIECES WERE LEFT INSIDE THE PATIENT. UNKNOWN SURGICAL DELAY.

  Patient problems: Insufficient Information

  MAUDE report 18317799 ↗
• InjuryOct 4, 2023Entrapment of Device; Off-Label Use; Adverse Event Without Identified Device or Use Problem; Entrapment of Device; Off-Label Use; Adverse Event Without Identified Device or Use Problem

  VIA USER REPORT: THE AFFECTED PERSON WAS FIRST PROVIDED WITH OSTEOSYNTHESIS IN THE CASE OF A FOREARM FRACTURE AND THEN, IN THE SAME SESSION, WAS GIVEN THE SHOULDER PROSTHESIS USING THE MEDICAL DEVICE DESCRIBED ABOVE. 45 MINUTES BEFORE THE END OF THE OPERATION, AN EMERGENCY (ILEUS) HAD TO BE INTRODUCED AND THE PERSON WITH THE FUNCTION "OPSPRINGER" ADDITIONALLY HAD TO BE LOOKED AFTER IN A THIRD OPERATING ROOM. ALL THE INSTRUMENTS USED IN THE OPERATION WENT TO THE AEMP FOR PREPARATION IMMEDIATELY AFTER THE END OF THE OPERATION. THE AEMP'S ON-DUTY STERILE SPECIALIST IMMEDIATELY NOTICED THE MISSING TEST IMPLANT FOR THE XTEND HUMERUS-PE INLAY STD 42+3MM AND IMMEDIATE FEEDBACK WAS RECEIVED TO THE SURGEON AND THE SURGICAL TEAM. THE IMMEDIATE CONTROL OF ALL DISCHARGE CONTAINERS WAS UNSUCCESSFUL. THE SAMPLE IMPLANT WAS NOT FOUND. FINDINGS OF THE POSTOPERATIVE X-RAY INSPECTION OF THE SHOULDER: NO EVIDENCE FOR RADIOPAQUE FOREIGN BODIES FINDINGS OF THE CT-INSPECTION OF (B)(6): NO FOREIGN MATERIAL CAN BE DETECTED OR DETECTED INLAY IN CORRECT POSITION THE PATIENT WAS DISCHARGED FROM THE HOSPITAL AFTER TREATMENT WAS COMPLETED. POSTOPERATIVE ABNORMALITIES WERE NOT RECOGNIZABLE. THE AFFECTED PERSON

  Patient problems: Foreign Body In Patient; Loss of Range of Motion

  MAUDE report 17873378 ↗
• MalfunctionSep 21, 2021Device-Device Incompatibility; Scratched Material; Device-Device Incompatibility; Scratched Material

  DURING THE SURGERY OF SHOULDER PROSTHESIS WITH DELTA XTEND, THE SURGEON PERFORMED THE TRIAL WITH THE TRIAL CUP STANDARD SIZE 42 +3. AFTER PERFORMING IT WAS QUITE DIFFICULT TO REMOVE THE TRIAL CUP, AND DURING THE PROCEDURES OF REMOVING THIS TRIAL CUP WAS DAMAGED ON THE EDGES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12510900 ↗
• MalfunctionJan 9, 2020Device Damaged Prior to Use; Device Damaged Prior to Use

  IT WAS REPORTED THAT THE TRIAL WAS DAMAGED BEYOND REPAIR AND NEEDS TO BE REPLACED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9571474 ↗
• MalfunctionJan 22, 2019Break; Break

  IT WAS REPORTED THAT THE HUMERAL CUP TRIALS HAVE SHAVING OF PLASTIC COMING OFF OF THEM. HAD TO OPEN THREE DIFFERENT TRAYS FOR CASE. ALL WENT WELL AND NOTHING LEFT IN PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8269049 ↗
• MalfunctionJan 22, 2019Break; Break

  IT WAS REPORTED THAT THE HUMERAL CUP TRIALS HAVE SHAVING OF PLASTIC COMING OFF OF THEM. HAD TO OPEN THREE DIFFERENT TRAYS FOR CASE. ALL WENT WELL AND NOTHING LEFT IN PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8269048 ↗
• MalfunctionJan 22, 2019Break; Break

  IT WAS REPORTED THAT THE HUMERAL CUP TRIALS HAVE SHAVING OF PLASTIC COMING OFF OF THEM. HAD TO OPEN THREE DIFFERENT TRAYS FOR CASE. ALL WENT WELL AND NOTHING LEFT IN PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8269035 ↗
• MalfunctionDec 4, 2018Device Damaged by Another Device; Device Damaged by Another Device

  IT WAS REPORTED THAT THE DELTA 42+3 POLY WAS DAMAGED QUITE BAD DURING DISLOCATION OF THE POLY TRIAL. NEEDS TO BE REPLACED BEFORE NEXT USE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8129221 ↗
• MalfunctionOct 25, 2018Component Missing; Component Missing

  MISSING COMPONENTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8006706 ↗