DEPUY 2038-20-000Recalls & reported problems
Depuy (Ireland) · DEPUY TRIAL TAPER SPACER +5 12/14 TAPER · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This DePuy hip trial spacer is used during hip replacement surgery to size and test the implant before the real part goes in. The 39 reports mostly describe spacers that no longer fit properly, cracking, breaking, or wearing out — pieces warping or going in crooked during surgery. No deaths and no injuries were reported, and most cases ended with no effect on the patient. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 39
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 39 adverse event reports that list this exact device (DI 10603295084341), received between Sep 7, 2017 and Feb 2, 2026 — classified as 39 malfunctions.
The most frequently reported specific device problem is “Naturally Worn” (15 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
- Naturally Worn15
- Device-Device Incompatibility11
- Break7
- Material Deformation7
- Material Twisted/Bent5
- Crack4
- Component Missing2
- Scratched Material2
Patient problems
- No Consequences Or Impact To Patient19
- No Clinical Signs, Symptoms or Conditions17
- Insufficient Information2
- No Code Available1
- No Information1
Recent adverse event reports
The 25 most recent of 39 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 2, 2026Device-Device Incompatibility; Unintended Movement
IT WAS REPORTED THAT THE GREEN UNI POLAR +5 TRIAL WAS NOT ABLE TO FIT IN THE BLACK SHELL THE RUBBER WAS LOOSENING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24232730 ↗MalfunctionNov 18, 2025Device-Device Incompatibility; Device-Device Incompatibility
THIS IS REPORT 1 OF 2 FOR (B)(4). IT WAS REPORTED THAT DURING A TOTAL HIP REPLACEMENT SURGERY, THE TRIAL SPACER 12/14 +5 DID NOT SIT FLUSH WITH THE HEAD TRIAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23583444 ↗MalfunctionNov 10, 2025Material Deformation; Material Deformation
REPORT 3 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 23508321 ↗MalfunctionOct 27, 2025Material Deformation; Material Deformation
IT WAS REPORTED THAT THE CALCAR PLANER SEEMED WARPED AND DID NOT PLANE THE CUT SURFACE SMOOTHLY. FURTHER THE +5 TRIAL SPACER AND THE 45X28 HEADS WERE SEVERELY "SCUFFED AND BATTERED" IN THE SET. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23392083 ↗MalfunctionJun 24, 2024Crack; Crack
IT WAS REPORTED THAT THERE WAS A CRACKED MOD ENDO UNI SPACER 12/14 +5. SURGICAL DELAY WAS UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19593884 ↗MalfunctionMay 17, 2024Break; Break
IT WAS REPORTED THAT ITEM BROKE WHEN SURGEON WAS TRYING TO REDUCE HIP. ALL PARTS RETRIEVED FROM PATIENT.
Patient problems: Insufficient Information
MAUDE report 19339689 ↗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 16878337 ↗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 16878303 ↗MalfunctionApr 12, 2023Break; Break
IT WAS REPORTED THAT THE COLLAR OF UNIPOLAR TRIAL ADAPTER BROKE AT THE TRUNNION CONNECTION INTO TWO PIECES DURING TRIAL REDUCTION. THERE WAS NO SURGICAL DELAY. ALL PIECES WERE RETRIEVED. NO FURTHER INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16725750 ↗MalfunctionDec 22, 2021Break; Crack; Break; Crack
IT WAS REPORTED THAT DURING SURGERY, THE +5 UNIPOLAR ADAPTOR CRACKED AND BROKE WHILE INSERTING INTO THE TRIAL HEAD. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13060537 ↗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 13003508 ↗MalfunctionJul 9, 2021Device-Device Incompatibility; Material Twisted/Bent; Naturally Worn; Device-Device Incompatibility; Material Twisted/Bent; Naturally Worn
INSTRUMENTS WORN DUE TO FAIR WEAR AND TEAR AFTER 8 YEARS OF USE. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12144379 ↗MalfunctionJul 9, 2021Device-Device Incompatibility; Material Twisted/Bent; Naturally Worn; Device-Device Incompatibility; Material Twisted/Bent; Naturally Worn
INSTRUMENTS WORN DUE TO FAIR WEAR AND TEAR AFTER 8 YEARS OF USE. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12144378 ↗MalfunctionJul 9, 2021Device-Device Incompatibility; Material Twisted/Bent; Naturally Worn; Device-Device Incompatibility; Material Twisted/Bent; Naturally Worn
INSTRUMENTS WORN DUE TO FAIR WEAR AND TEAR AFTER 8 YEARS OF USE. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12144356 ↗MalfunctionJun 24, 2021Device-Device Incompatibility; Material Twisted/Bent; Naturally Worn; Device-Device Incompatibility; Material Twisted/Bent; Naturally Worn
IT WAS REPORTED THAT THE FOLLOWING INSTRUMENTS WERE REPORTED DUE TO WEAR. TR SPACER 12/14 +5 INC RINGS. TR SPACER 12/14 +0 INC RINGS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12058212 ↗MalfunctionJun 2, 2021Break; Break
IT WAS REPORTED THAT THE SPACER TRIAL BROKE. ALL PIECES WERE RETRIEVED. THERE WAS NO DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11922171 ↗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 11716662 ↗MalfunctionMar 21, 2021Break; Crack; Device-Device Incompatibility; Break; Crack; Device-Device Incompatibility
ADDITIONAL INFORMATION RECEIVED STATES THAT THE INSTRUMENT BROKE INTO TWO PIECES. ALL PIECES WERE RETRIEVED FROM THE PATIENT.
Patient problems: Insufficient Information
MAUDE report 11536861 ↗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 11059388 ↗MalfunctionSep 17, 2020Material Deformation; Material Deformation
INCIDENT HAPPENED IN A(B)(6) HOSPITAL ((B)(6)) 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 Code Available; No Consequences Or Impact To Patient
MAUDE report 10547565 ↗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 9856576 ↗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 9573194 ↗MalfunctionOct 10, 2019Loose or Intermittent Connection; Material Deformation; Scratched Material; Unintended Movement; Loose or Intermittent Connection; Material Deformation; Scratched Material; Unintended Movement
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 9176222 ↗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 9031700 ↗MalfunctionAug 15, 2019Component Missing; Component Missing
I NOTICED TODAY THAT THE RUBBER LOCKING RING IS MISSING FROM THE 3 CATHCART UNIPOLAR SLEEVE TRIALS. THESE WERE NOT USED FOR THE CASE, WE WERE USING ANOTHER INSTRUMENT ON THE TRAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8897380 ↗
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- 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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