DEPUY 2038-16-000Recalls & reported problems
Depuy (Ireland) · DEPUY TRIAL TAPER SPACER -3 12/14 TAPER · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This DePuy trial taper spacer is a sizing tool used during surgery to fit an implant. All 129 reports are malfunctions, with no deaths or injuries; many describe parts breaking, worn or cracked rims, and debris in the locking mechanism found during cleaning. Reports rose to 13 in the last 12 months from 8 in the 12 months before. 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
- 129
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 129 adverse event reports that list this exact device (DI 10603295084327), received between Aug 25, 2017 and Feb 13, 2026 — classified as 129 malfunctions.
The most frequently reported specific device problem is “Break” (64 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
- Break64
- Device-Device Incompatibility31
- Naturally Worn21
- Scratched Material11
- Crack10
- Material Twisted/Bent7
- Material Deformation5
- Material Integrity Problem5
Patient problems
- No Clinical Signs, Symptoms or Conditions65
- No Consequences Or Impact To Patient51
- Insufficient Information8
- No Code Available4
- No Information3
- Not Applicable2
- No Patient Involvement1
Recent adverse event reports
The 25 most recent of 129 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 13, 2026Contamination /Decontamination Problem
IT WAS REPORTED THAT IT DID NOT HAPPEN IN SURGERY, SPD FOUND DEBRIS COMING OUT OF THE LOCKING MECHANISM AND CANNOT BE CLEANED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24333519 ↗MalfunctionJan 16, 2026Break; Device-Device Incompatibility
IT WAS REPORTED THAT DURING ROUTINE MEDICAL DEVICE REPROCESSING, IT WAS NOTICED THAT THE RIMS OF THE TRIAL SPACERS WERE WORN CHIPPED AND COULD NO LONGER CONNECT TO THE MONOPOLAR HEAD TRIALS PROPERLY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24094943 ↗MalfunctionJan 16, 2026Break; Device-Device Incompatibility
IT WAS REPORTED THAT DURING ROUTINE MEDICAL DEVICE REPROCESSING, IT WAS NOTICED THAT THE RIMS OF THE TRIAL SPACERS WERE WORN CHIPPED AND COULD NO LONGER CONNECT TO THE MONOPOLAR HEAD TRIALS PROPERLY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24094828 ↗MalfunctionJan 16, 2026Break; Device-Device Incompatibility
IT WAS REPORTED THAT DURING ROUTINE MEDICAL DEVICE REPROCESSING, IT WAS NOTICED THAT THE RIMS OF THE TRIAL SPACERS WERE WORN CHIPPED AND COULD NO LONGER CONNECT TO THE MONOPOLAR HEAD TRIALS PROPERLY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24094630 ↗MalfunctionDec 24, 2025Break; Break
IT WAS REPORTED THAT THE TAPERED TRIALS WERE BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23888887 ↗MalfunctionDec 24, 2025Break; Break
BROKEN TAPERED SPACER TRIALS. BROKEN INTO MULTIPLE PIECES. WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? --> UNKNOWN, WAS PROCEDURE SUCCESSFULLY COMPLETED? --> UNKNOWN, WERE FRAGMENTS GENERATED? --> UNKNOWN, IF YES, WERE THEY REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION? --> UNKNOWN, PATIENT STATUS/ OUTCOME / CONSEQUENCES --> NO PATIENT INVOLVEMENT, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: --> UNKNOWN, IS THE PATIENT PART OF A CLINICAL STUDY --> UNKNOWN, (B)(4). DEVICE PROPERTY OF -->NONE, DEVICE IN POSSESSION OF -->NONE, (B)(4) DEVICE PROPERTY OF -->NONE, DEVICE IN POSSESSION OF -->NONE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23888135 ↗MalfunctionDec 24, 2025Break; Break
BROKEN TAPERED SPACER TRIALS. BROKEN INTO MULTIPLE PIECES. WAS SURGERY DELAYED DUE TO THE REPORTED EVENT?: UNKNOWN, WAS PROCEDURE SUCCESSFULLY COMPLETED?: UNKNOWN, WERE FRAGMENTS GENERATED?: UNKNOWN, IF YES, WERE THEY REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION?: UNKNOWN, PATIENT STATUS/ OUTCOME / CONSEQUENCES: NO PATIENT INVOLVEMENT, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: UNKNOWN, IS THE PATIENT PART OF A CLINICAL STUDY: UNKNOWN, (B)(6). DEVICE PROPERTY OF: NONE, DEVICE IN POSSESSION OF: NONE, (B)(6). DEVICE PROPERTY OF: NONE, DEVICE IN POSSESSION OF: NONE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23888134 ↗MalfunctionDec 15, 2025Break; Crack; Break; Crack
IT WAS REPORTED THAT DURING ROUTINE MEDICAL DEVICE PROCESSING, STAFF FOUND TRIAL SPACERS BROKEN AND NO LONGER ATTACHED TO TRIAL BED SEGMENTS. CRACKS IN THE TRIAL SLEEVE'S INNER PLASTIC HOLE PREVENTED THE SPACERS FROM MAINTAINING THEIR SHAPE. THERE WERE NO PATIENT CONSEQUENCES. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23806966 ↗MalfunctionDec 15, 2025Break; Crack; Break; Crack
IT WAS REPORTED THAT DURING ROUTINE MEDICAL DEVICE PROCESSING, STAFF FOUND TRIAL SPACERS BROKEN AND NO LONGER ATTACHED TO TRIAL BED SEGMENTS. CRACKS IN THE TRIAL SLEEVE'S INNER PLASTIC HOLE PREVENTED THE SPACERS FROM MAINTAINING THEIR SHAPE. THERE WERE NO PATIENT CONSEQUENCES. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23806910 ↗MalfunctionDec 15, 2025Break; Crack; Break; Crack
IT WAS REPORTED THAT DURING ROUTINE MEDICAL DEVICE PROCESSING, STAFF FOUND TRIAL SPACERS BROKEN AND NO LONGER ATTACHED TO TRIAL BED SEGMENTS. CRACKS IN THE TRIAL SLEEVE'S INNER PLASTIC HOLE PREVENTED THE SPACERS FROM MAINTAINING THEIR SHAPE. THERE WERE NO PATIENT CONSEQUENCES. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23806857 ↗MalfunctionDec 9, 2025Break; Break
IT WAS REPORTED THAT PART OF THE BOTTOM OF THE -3 TAPERED SPACER WAS CHIPPED OFF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23760398 ↗MalfunctionNov 18, 2025Break; Break
IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, THE SURGEON BROKE PART WHEN REMOVING THE INSTRUMENT. ALL BROKEN PARTS WERE RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23586445 ↗MalfunctionNov 10, 2025Material Deformation; Material Deformation
REPORT 1 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 23508317 ↗MalfunctionJul 29, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE STERILIZATION WAS UNABLE TO GET THE 48MM SHELL AND THE -3 SPACER APART.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22641474 ↗MalfunctionJul 28, 2025Break; Break
IT WAS REPORTED THAT THESE ITEMS BECAME BROKEN WHEN TRYING TO REMOVE TRIALS ON BACK TABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22633134 ↗MalfunctionJul 9, 2025Break; Break
IT WAS REPORTED THAT THE TRIAL BROKE AFTER CASE AFTER COMING THROUGH THE WASH.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22463604 ↗MalfunctionJun 13, 2025Break; Break
IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL HIP REPLACEMENT ON (B)(6) 2025. A PIECE OF THE -3 TRIAL BROKE OFF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22205916 ↗MalfunctionJun 2, 2025Break; Break
IT WAS REPORTED THAT PATIENT UNDERWENT HIP SURGERY ON (B)(6) 2025. AFTER TRIALING FOR HIP STABILITY, THEY REMOVED THE TRIAL AND THEY NEEDED TO REMOVE THE -3 SPACER TRIAL FROM THE HEAD TRIAL. UPON EXTRACTION FROM THE HEAD TRIAL, THE DISC PART OF THE -3 SPACER TRIAL BROKE. ALL PIECES WERE CONFIRMED REMOVED FROM THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22124049 ↗MalfunctionApr 24, 2025Break; Break
IT WAS REPORTED THAT TRIAL BROKE ON BACK TABLE WHEN REMOVING FROM TRIAL STEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21899005 ↗MalfunctionDec 5, 2024Device-Device Incompatibility; Scratched Material; Device-Device Incompatibility; Scratched Material
IT WAS REPORTED THAT THE -3MM UNIPOLAR SPACER TRIAL WAS VERY SCRATCHED UP AND WAS HARD TO GET TO SIT ON THE NECK TRIAL. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: Insufficient Information
MAUDE report 20855320 ↗MalfunctionNov 5, 2024Break; Break
IT WAS REPORTED THAT TRIAL SPACER BROKEN DURING REMOVAL. ALL PIECES WERE RETRIEVED.
Patient problems: Insufficient Information
MAUDE report 20614236 ↗MalfunctionOct 2, 2024Break; Break
IT WAS REPORTED THAT DURING HEMI HIP SURGERY, ONE ITEM BROKE. DOCTORS HAD BACKUPS AVAILABLE, SO THERE WERE NO DELAY IN SURGERY.
Patient problems: Insufficient Information
MAUDE report 20353520 ↗MalfunctionJul 10, 2024Crack; Device-Device Incompatibility; Crack; Device-Device Incompatibility
ADDITIONAL INFORMATION RECEIVED: A. WAS THERE ANY PATIENT HARM/CONSEQUENCE RELATED TO THE EVENT? NO HARM. B. WAS THERE ANY SURGICAL DELAY RELATED TO THE EVENT? IF YES, WHAT IS THE DURATION OF THE DELAY? NO DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19714977 ↗MalfunctionJun 21, 2024Break; Crack; Break; Crack
IT WAS REPORTED THAT THE -3 TAPERED SPACER TRIAL CRACKED AND BROKE INTO 3 PIECES WHILE ATTEMPTING TO REMOVE IT FROM THE NECK TRIAL. ALL PIECES WERE RETRIEVED AND SURGICAL TIME WAS NOT EXTENDED. NO ADVERSE CONSEQUENCES FOR THE PATIENT OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19582154 ↗MalfunctionJun 1, 2024Break; Break
ADDITIONAL INFORMATION RECEIVED STATES THAT THERE WAS NO DELAY AND NO ADVERSE CONSEQUENCES THAT AFFECTED THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19442745 ↗
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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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