DELTA XTEND 2307-38-403Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 10603295115816), received between Jan 22, 2019 and Jun 27, 2025 — classified as 21 malfunctions.

The most frequently reported specific device problem is “Break” (10 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• 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 22345224 ↗
• 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 22345185 ↗
• 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 22344979 ↗
• 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 22344710 ↗
• 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 20075302 ↗
• MalfunctionSep 19, 2023Break; Break

  IT WAS REPORTED THAT 38 +3 HUMERAL POLY TRIAL IS BROKEN. WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? NO. WAS PROCEDURE SUCCESSFULLY COMPLETED? YES. WERE FRAGMENTS GENERATED? NO. IF YES, WERE THEY REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION? UNKNOWN, PATIENT STATUS/ OUTCOME / CONSEQUENCES NO, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: UNKNOWN, IS THE PATIENT PART OF A CLINICAL STUDY UNKNOWN, IP-01830074. DEVICE PROPERTY OF NONE, DEVICE IN POSSESSION OF NONE. BY CHECKING THIS BOX I CERTIFY THAT ALL INFORMATION THAT ARE KNOWN/AVAILABLE HAS BEEN DISCLOSED. IF ANY NEW INFORMATION WILL BE MADE AVAILABLE, THE ADDITIONAL INFORMATION WILL BE SUBMITTED THROUGH CST. TRUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17774575 ↗
• 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 17728137 ↗
• MalfunctionJul 10, 2023Break; Naturally Worn; Scratched Material; Break; Naturally Worn; Scratched Material

  IT WAS REPORTED THAT THE STANDARD HUMERAL CUP TRIAL 38+3 IS VERY NOTCHED, FRAGMENTS OF POLY COULD DISPLACE INTO THE JOINT SPACE. AFFECTS ACCURATE TRIAL REDUCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17295223 ↗
• MalfunctionJul 10, 2023Break; Naturally Worn; Scratched Material; Break; Naturally Worn; Scratched Material

  IT WAS REPORTED THAT THE STANDARD HUMERAL CUP TRIAL 38+3 IS VERY NOTCHED, FRAGMENTS OF POLY COULD DISPLACE INTO THE JOINT SPACE. AFFECTS ACCURATE TRIAL REDUCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17295205 ↗
• MalfunctionMar 21, 2023Break; Scratched Material; Break; Scratched Material

  IT WAS REPORTED THAT DEVICE WAS GOUGED AND CHIPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16583088 ↗
• MalfunctionSep 16, 2022Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT THE POLY TRIAL WAS DEFORMED AND WOULDN T EASILY FIT IN EPIPHYSIS. SURGICAL DELAY WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15438140 ↗
• MalfunctionAug 22, 2022Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn

  IT WAS REPORTED THAT THE POLY TRIAL IS STRIPPED AND WON'T SCREW IN CORRECTLY. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15264820 ↗
• MalfunctionSep 15, 2021Break; Break

  COMPASS CASE (B)(4) REPORTS: IT WAS REPORTED THAT THE 38MM +3 POLY TRIAL SPLIT DURING TRIALING. ALL PIECES WERE FOUND AND DISCARDED. NO SURGICAL DELAY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12475888 ↗
• MalfunctionFeb 4, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE" 38 +3 HUMERAL CUP TRIAL GOT STUCK AND WAS DAMAGED DURING EXTRACTION. NO ADDITIONAL INFORMATION". TWO MINUTES SURGICAL DELAY.

  Patient problems: Insufficient Information

  MAUDE report 11282079 ↗
• 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 10314348 ↗
• 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 10314344 ↗
• 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 10314306 ↗
• MalfunctionMar 27, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE TRIAL IMPLANT WOULD NOT SIT FLUSH. A SURGICAL DELAY OF FIVE MINUTES.

  Patient problems: No Code Available

  MAUDE report 9890812 ↗
• 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 8268982 ↗
• 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 8268978 ↗
• 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 8268961 ↗