DELTA XTEND 2307-76-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10603295116196), received between Sep 17, 2018 and Aug 6, 2024 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (2 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 6, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING A PRIMARY REVERSE TOTAL SHOULDER ARTHROPLASTY, THE CENTERED EPI1/2 BULLET WOULD NOT PROPERLY FIT ONTO THE PROXIMAL REAMING GUIDE. THERE WERE NO BROKEN PIECES. THERE WERE NO DELAYS OR COMPLICATIONS TO THE SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19922232 ↗
• MalfunctionJun 7, 2024Break; Break

  IT WAS REPORTED THAT THE REAMING ADAPTOR WAS BROKEN.

  Patient problems: Insufficient Information

  MAUDE report 19488658 ↗
• MalfunctionMay 3, 2023Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE DELTA XTENC CUP TRIAL AND CENTRAL ADAPTOR FOR REAMING WERE BOTH DAMAGED THROUGH NORMAL WEAR AND TEAR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16859384 ↗
• MalfunctionFeb 23, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT THIS WAS AN UNKNOWN PROCEDURE PERFORMED ON (B)(6) 2022. WHEN THE SURGEON APPLIED REAMING, SHE FOUND SOME IRON POWDER. THEY POSTOPERATIVELY FOUND GROUND TRACES ON THE REAMING ADAPTER. THERE WAS NO HARM TO THE PATIENT. THE SURGEON WONDERED IF THE INNER DIAMETER OF THE REAMER AND OUTER DIAMETER OF THE ADAPTER MIGHT HAVE FALLEN INTO SPECIFICATION RANGES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13583605 ↗
• MalfunctionSep 20, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE REAMING ADAPTOR WAS BROKEN WHEN IT CAME TO THE CUSTOMER. IT WAS NOTICED DURING THE SURGERY THAT THIS ITEM WELDS TOGETHER (GETS STUCK) WITH THIS REAMER. THIS MIGHT CAUSE A HUMERUS FRACTURE; LUCKILY THIS WAS AVOIDED THIS TIME DUE TO A VERY EXPERIENCED SURGEON. THE LOAN SET WILL BE RETURNED LATER THIS WEEK AND IT´S VERY IMPORTANT THAT THIS INSTRUMENT WILL BE REPLACED. THE REAMER MIGHT BE DAMAGED AS WELL DUE TO THE DEFECT INSTRUMENT SO PLEASE CHECK THAT AS WELL. THERE WAS A TEN-MINUTE SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12497293 ↗
• MalfunctionSep 17, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  COMPLAINT DESCRIPTION: IT WAS REPORTED THAT THE EPI 1 TOP HAT WOULD NOT FILL OVER THE SLEEVES AND GOT STUCK DURING SURGERY. INVESTIGATION METHOD: (B)(6) 2017: COMPLAINT SAMPLE DEVICES SHIPPED BY (B)(6). AWB# TO BE DETERMINED. (B)(6). INVESTIGATION SUMMARY: IT WAS REPORTED THAT THE EPI 1 TOP HAT WOULD NOT FILL OVER THE SLEEVES AND GOT STUCK DURING SURGERY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7882450 ↗