DELTA XTEND ETH001Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295256625), received between Aug 24, 2018 and Jul 23, 2024 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (3 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 23, 2024Break; Break

  ADDITIONAL INFORMATION WAS RECEIVED: THE INSTRUMENT BROKE INTO TWO DISTINCT PIECES. NOTHING OF ANY DESCRIPTION REMAINED IN THE PATIENT. THERE WAS PERHAPS A ONE MINUTE DELAY WHILST THE SECOND INSTRUMENT WAS FOUND AND OPENED. THE REVISION SURGERY WAS PLANNED BY THE SURGEON FROM THE MOMENT THE FIRST OPERATION TOOK PLACE YEARS AGO. A YOUNGER PATIENT REQUIRED A SHOULDER ARTHROPLASTY BUT WAS DEEMED TOO YOUNG FOR A REVERSE, BUT UNSUITED TO ANY ANATOMIC OPTION AS SHE WAS SEVERELY CUFF DEFICIENT. SO SHE WAS FITTED WITH A DELTA STEM AND CTA HEAD, WITH OPTION TO REVISE TO A REVERSE IN HER LATER YEARS, IE, RECENTLY. THE ORIGINAL PLAN WAS TO REMOVE THE CTA HEAD, REMOVE THE EPI COMPONENT FROM THE WELL FIXED STEM, ANTEVERT A NEW EPI COMPONENT AND COMPLETE THE GLENOID PART OF THE PROCEDURE. WHEN THIS WAS ATTEMPTED THOUGH, THE SURGEON REALISED THAT THE STEM WAS TOO HIGH, SO HE ELECTED TO REMOVE IT AND REPLACE IT WITH A NEW STEM, IMPLANTED AT THE CORRECT HEIGHT. UPON ATTEMPTING REMOVAL OF THE STEM, THE INSTRUMENT BROKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19804475 ↗
• MalfunctionOct 20, 2021Break; Break

  IT WAS REPORTED THAT THE INSTRUMENT HAS A BROKEN SCREW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12666421 ↗
• MalfunctionAug 24, 2018Break; Break

  IT WAS REPORTED THAT SURGEON WAS USING THE EXTRACTOR TO REMOVE AN IMPLANT. ONCE REMOVED, NOTICED THE THREADED SCREW ON EXTRACTOR WAS BROKEN IN TWO PIECES. INSTRUMENT FAILURE ONLY. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7813017 ↗