DELTA XTEND 2307-38-409Recalls & reported problems
Depuy (Ireland) · DELTA Xtend STANDARD HUMERAL CUP TRIAL DIA 38 +9MM · Class 1
All models of DELTA XTEND (194)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 13
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10603295115830), received between Jan 22, 2019 and Jun 8, 2026 — classified as 13 malfunctions.
The most frequently reported specific device problem is “Scratched Material” (7 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.
Reports received per month
Most reported problems
Device problems
- Scratched Material7
- Break6
- Device-Device Incompatibility4
- Use of Device Problem3
- Naturally Worn2
Patient problems
- No Clinical Signs, Symptoms or Conditions6
- No Consequences Or Impact To Patient6
- No Code Available3
- Insufficient Information1
Recent adverse event reports
The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 8, 2026Break
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 25429356 ↗MalfunctionJun 27, 2025Device-Device Incompatibility; Scratched Material; Device-Device Incompatibility; Scratched Material
IT WAS REPORTED THAT SURGEON WANTS ALL THE TRIALS REPLACED BECAUSE OF CUTS AND GOUGES AND SAID THEY DIDN'T FIT WELL WHEN TRIALING DUE TO AGE OF TRIALS. THIS COMPLAINT IS LINKED TO PC-(B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22349539 ↗MalfunctionJun 27, 2025Device-Device Incompatibility; Scratched Material; Device-Device Incompatibility; Scratched Material
IT WAS REPORTED THAT SURGEON WANTS ALL THE TRIALS REPLACED BECAUSE OF CUTS AND GOUGES AND SAID THEY DIDN'T FIT WELL WHEN TRIALING DUE TO AGE OF TRIALS. THIS COMPLAINT IS LINKED TO (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22349476 ↗MalfunctionJun 27, 2025Device-Device Incompatibility; Scratched Material; Device-Device Incompatibility; Scratched Material
IT WAS REPORTED THAT SURGEON WANTS ALL THE TRIALS REPLACED BECAUSE OF CUTS AND GOUGES AND SAID THEY DIDN'T FIT WELL WHEN TRAILING DUE TO AGE OF TRIALS. THIS COMPLAINT IS LINKED TO (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22345615 ↗MalfunctionJun 27, 2025Device-Device Incompatibility; Scratched Material; Device-Device Incompatibility; Scratched Material
IT WAS REPORTED THAT SURGEON WANTS ALL THE TRIALS REPLACED BECAUSE OF CUTS AND GOUGES AND SAID THEY DIDN'T FIT WELL WHEN TRAILING DUE TO AGE OF TRIALS. THIS COMPLAINT IS LINKED TO (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22344912 ↗MalfunctionAug 27, 2024Break; Naturally Worn; Break; Naturally Worn
IT WAS REPORTED THAT INSTRUMENTS ARE SHOWING SIGNIFICANT WEAR FROM EXCESSIVE USE. BEAT UP TRIALS.
Patient problems: Insufficient Information
MAUDE report 20075306 ↗MalfunctionSep 12, 2023Break; Naturally Worn; Break; Naturally Worn
IT WAS REPORTED THAT THE PLASTIC TRIALS HAVE BECOME SO WORN FROM REDUCING AND BEING USED OVER THE YEARS THAT THEY HAVE STARTED DEVELOPING DEEP ABRASIONS AND CUTS INTO THE PLASTIC. PIECES OF THESE CUTS HAVE BEGUN SEPARATING FROM THE TRIAL. DURING SURGERY, ONE SMALL PIECE CAME OFF IN THE PATIENT BUT WAS IMMEDIATELY RETRIEVED. NO ADVERSE AFFECTS WERE EXPERIENCED BY THE PATIENT. ALL PIECES WERE RETRIEVED AND SURGERY WAS DELAYED BY APPROXIMATELY 17 SECONDS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17728133 ↗MalfunctionJul 23, 2020Use of Device Problem; Scratched Material; Use of Device Problem; Scratched Material
IT WAS REPORTED THAT THE 38 POLY TRIALS ARE DAMAGED WITH SCARS AND MISSING PLASTIC IN AREAS SURGEON AND SPD WANTED THEM REPLACED. PROTECTIVE PLATE IS BENT AND WON¿T SIT FLUSH ON THE BONE. THE REAMERS ARE DULLED AND HAVE BURRS . THESE ITEMS WERE PULLED OUT OF THE SETS AND NOT USED IN A CASE.
Patient problems: No Code Available; No Consequences Or Impact To Patient
MAUDE report 10314361 ↗MalfunctionJul 23, 2020Use of Device Problem; Scratched Material; Use of Device Problem; Scratched Material
IT WAS REPORTED THAT THE 38 POLY TRIALS ARE DAMAGED WITH SCARS AND MISSING PLASTIC IN AREAS SURGEON AND SPD WANTED THEM REPLACED. PROTECTIVE PLATE IS BENT AND WON¿T SIT FLUSH ON THE BONE. THE REAMERS ARE DULLED AND HAVE BURRS . THESE ITEMS WERE PULLED OUT OF THE SETS AND NOT USED IN A CASE.
Patient problems: No Code Available; No Consequences Or Impact To Patient
MAUDE report 10314338 ↗MalfunctionJul 23, 2020Use of Device Problem; Scratched Material; Use of Device Problem; Scratched Material
IT WAS REPORTED THAT THE 38 POLY TRIALS ARE DAMAGED WITH SCARS AND MISSING PLASTIC IN AREAS SURGEON AND SPD WANTED THEM REPLACED. PROTECTIVE PLATE IS BENT AND WON¿T SIT FLUSH ON THE BONE. THE REAMERS ARE DULLED AND HAVE BURRS . THESE ITEMS WERE PULLED OUT OF THE SETS AND NOT USED IN A CASE.
Patient problems: No Code Available; No Consequences Or Impact To Patient
MAUDE report 10314332 ↗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 8269028 ↗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 8269022 ↗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 8269019 ↗
Other TEMPLATE devices
- ATTUNE 2544-01-014Depuy (Ireland) · TEMPLATE802 reports
- ATTUNE 2545-00-546Depuy (Ireland) · TEMPLATE1 recall301 reports
- ARTICUL/EZE 2531-51-000Depuy (Ireland) · TEMPLATE323 reports
- DELTA XTEND 2307-95-000Depuy (Ireland) · TEMPLATE315 reports
- ATTUNE 2545-00-547Depuy (Ireland) · TEMPLATE1 recall231 reports
- ATTUNE 2544-00-520Depuy (Ireland) · TEMPLATE279 reports
- ATTUNE 2545-00-545Depuy (Ireland) · TEMPLATE1 recall221 reports
- ARTICUL/EZE 2530-91-000Depuy (Ireland) · TEMPLATE271 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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