DEPUY 2038-22-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 10603295084358), received between Sep 7, 2017 and Apr 24, 2026 — classified as 26 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (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.

Most reported problems

Recent adverse event reports

The 25 most recent of 26 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 24, 2026Crack; Illegible Information

  IT WAS REPORTED THAT THE LITTLE CRACKS APPEAR ON THE PRODUCTS AND LOT NUMBERS ARE UNREADABLE ON THE PRODUCTS. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24988084 ↗
• MalfunctionNov 10, 2025Material Deformation; Material Deformation

  REPORT 4 OF 4 FOR (B)(4). IT WAS REPORTED THAT THE UNIPOLAR TRIAL SPACERS WERE GOING INTO THE TRIAL HEAD CROOKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23508324 ↗
• MalfunctionMay 5, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE TRIALS FOR THE UNIPOLAR SPACERS WERE GETTING STUCK AND NOT FITTING THE TRIAL HEAD CORRECTLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16878319 ↗
• MalfunctionMay 5, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE TRIALS FOR THE UNIPOLAR SPACERS WERE GETTING STUCK AND NOT FITTING THE TRIAL HEAD CORRECTLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16878295 ↗
• MalfunctionFeb 8, 2023Break; Break

  IT WAS REPORTED THAT THE HANDLE WILL NOT ACCEPT HEAD TRIALS. METAL LOCKING BALL WILL NOT BUDGE. TRIAL SPACERS HAVE BROKEN BROWN LOCKING RINGS. BROACH HANDLE WILL NOT OPEN. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16323108 ↗
• MalfunctionDec 14, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT SPACER TRIALS ARE WARPED AND WON¿T FIT IN HEAD TRIALS AND NEED REPLACED. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13003458 ↗
• MalfunctionSep 27, 2021Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE ITEMS WERE WORN OUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12533945 ↗
• MalfunctionSep 9, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE TRIAL SPACER FOR +10 IS MISSING THE BROWN RING. THE TRIAL SPACER FOR THE -3 IS NOT STAYING FIXATED CUP TRIAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12446233 ↗
• MalfunctionApr 23, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE INSTRUMENTS ARE HEAVILY WORN AND NEED TO BE REPLACED. NOTHING LEFT IN PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11716663 ↗
• MalfunctionDec 22, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE CURRENT DESIGN OF THE UNI POLAR TRIAL IS NOT WORKING. THE SPACER TRAILS GET STUCK IN THE TRAIL HEAD AND ON TRAIL NECKS. THEY ALSO HAVE THE POTENTIAL TO TEMPORARILY GET STUCK ON IMPLANTED STEM AND ARE DIFFICULT TO GET OFF. THIS IS NOT ISOLATED TO THESE SPECIFIC TRIALS LISTED ON THIS FORM. THIS IS A PROBLEM WITH DESIGN. I DO NOT NEED NEW ONES ORDERED OF THIS SAME DESIGN. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11059430 ↗
• MalfunctionSep 17, 2020Material Deformation; Material Deformation

  INCIDENT HAPPENED IN (B)(6) HOSPITAL (CSSD) DEPARTMENT WHILE AUTOCLAVING THE INSTRUMENTS. BELOW MENTIONED INSTRUMENTS HAS MELTED DURING STERILIZATION. 203818000, TRIAL SPACER (12/14 0MM); 203820000, TRIAL SPACER (12/14 5MM); 203822000, TRIAL SPACER (12/14 10MM); 205516000, BIPOLAR RETAINING CLIP (28MM). NO CONSEQUENCE ON PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Code Available; No Consequences Or Impact To Patient

  MAUDE report 10547570 ↗
• MalfunctionAug 12, 2020Break; Break

  IT WAS REPORTED THAT A TRIAL SPACER 12/14 +10 BROKE AROUND THE RING WHEN PUTTING INTO THE TRIAL HEAD. THERE WERE NO PIECES LEFT IN THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10396711 ↗
• MalfunctionMar 19, 2020Break; Component Missing; Break; Component Missing

  IT WAS REPORTED THAT IT WAS NOTICED THAT THE LOCKING RING ON TRIAL TAPER SPACER HAD BEEN REMOVED RENDERING INSTRUMENT USELESS. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9853521 ↗
• MalfunctionJan 9, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE FOUR UNIPOLAR TRIALS FROM THE MODULAR ENDO HEAD TRIAL INSTRUMENT SET DO NOT FIT INSIDE OF THE TRIAL HEADS IN THE CORRECT POSITION. THE WHITE HANDLE EXTRACTOR WILL NOT EXTRACT THE UNIPOLAR TRIALS FROM THE TRIAL HEAD. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9573192 ↗
• MalfunctionOct 10, 2019Loose or Intermittent Connection; Material Deformation; Scratched Material; Loose or Intermittent Connection; Material Deformation; Scratched Material

  IT WAS REPORTED THAT WHILE INSPECTING INSTRUMENTS PRIOR TO STERILIZATION, IT WAS NOTICED SCRATCH MARKS AND WEAR, AS WELL AS LOOSENING OF BROWN RING THAT COULD AFFECT THE SPACER STAYING IN THE TRIAL HEAD. THESE WERE NOT USED IN SURGERY AND SURGERY WAS NOT DELAYED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9176288 ↗
• MalfunctionSep 13, 2019Naturally Worn; Scratched Material; Naturally Worn; Scratched Material

  MDR STAFF INDICATED THAT THE FOLLOWING TRIAL SPACERS ARE WORN AND GOUGED AND REQUIRE REPLACEMENT. NO SURGICAL DELAY. NO PATIENT CONSEQUENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9031797 ↗
• MalfunctionSep 4, 2019Break; Break

  IT WAS REPORTED THAT THE UNIPOLAR TRIAL LOCKING RING BROKE. PLEASE SEND REPLACEMENT SOS TO (B)(6) OFFICE. NO ADDITIONAL INFORMATION. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8962032 ↗
• MalfunctionJul 1, 2019Material Deformation; Naturally Worn; Material Deformation; Naturally Worn

  MDR STAFF INDICATED THAT THE FOLLOWING INSTRUMENTS REQUIRE REPLACEMENT: 203816000 - TRIAL SPACER IS WORN AND GOUGED, 203818000 - TRIAL SPACER IS WORN AND GOUGED, 203820000 - TRIAL SPACER IS WORN AND GOUGED, 203822000 - TRIAL SPACER IS WORN AND GOUGED. IN SHORT THE TRAY HAS BEEN SUBJECTED TO A LOT OF USE AND THE TRIAL SPACERS ALL REQUIRE REPLACEMENT. NO PATIENT CONSEQUENCE. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8750448 ↗
• MalfunctionFeb 7, 2019Break; Break

  THE FOLLOWING UNI-POLAR ADAPTER TRIALS BROKE DURING SURGERY: +10.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8315574 ↗
• MalfunctionJul 20, 2018Material Deformation; Material Deformation

  ALL INSTRUMENTS HAVE NORMAL WEAR AND NEED TO BE REPLACED. PATIENT CONSEQUENCE? NO. IS THE INFORMATION BEING SUBMITTED FOR THIS COMPLAINT ALL THE DETAILS THAT ARE KNOWN/AVAILABLE REGARDING THIS EVENT? YES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7706660 ↗
• MalfunctionJul 20, 2018Material Deformation; Material Deformation

  ALL INSTRUMENTS HAVE NORMAL WEAR AND NEED TO BE REPLACED. PATIENT CONSEQUENCE? NO. IS THE INFORMATION BEING SUBMITTED FOR THIS COMPLAINT ALL THE DETAILS THAT ARE KNOWN/AVAILABLE REGARDING THIS EVENT? YES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7706154 ↗
• MalfunctionNov 29, 2017Naturally Worn; Naturally Worn

  HEMI ARTHROPLASTY SLEEVES WORN DUE TO USAGE NUMBERS WORN OFF.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7069807 ↗
• MalfunctionNov 27, 2017Naturally Worn; Naturally Worn

  HEMI ARTHROPLASTY SLEEVES WORN DUE TO USAGE. NUMBERS WORN OFF.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7062276 ↗
• MalfunctionNov 27, 2017Naturally Worn; Naturally Worn

  HEMI ARTHROPLASTY SLEEVES WORN DUE TO USAGE. NUMBERS WORN OFF.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7062266 ↗
• MalfunctionNov 27, 2017Naturally Worn; Naturally Worn

  ACETABULAR GRATERS DULL DUE TO NORMAL USAGE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7062129 ↗