DEPUY 2038-18-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 145 adverse event reports that list this exact device (DI 10603295084334), received between Sep 6, 2017 and Sep 10, 2026 — classified as 145 malfunctions.

The most frequently reported specific device problem is “Break” (87 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 145 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 10, 2026Break

  It was reported that during a surgical procedure of the hip it was observed that the scrub tech broke the device on the back table trying to remove from the head trial. All parts retrieved.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50722613 ↗
• MalfunctionJun 5, 2026Break

  IT WAS REPORTED THAT THE SHELL AND THE SPACER BROKE WHEN TRYING TO DISASSEMBLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25414370 ↗
• MalfunctionMay 20, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT UNIPOLAR ADAPTER TRIAL WAS COMPLETELY STUCK IN 52 MOD ENDO TRIAL. CANNOT PRY IT OUT WHATSOEVER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25230679 ↗
• MalfunctionApr 16, 2026Crack; Fracture; Difficult to Insert; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING ROUTINE MEDICAL DEVICE REPROCESSING, IT WAS OBSERVED THAT THE LOCKING RING AROUND THE EDGE OF THE TAPERED SPACER DEVICE HAD BECOME CRACKED AND WOULD NO LONGER SUCCESSFULLY CONNECT WITH THE MODULAR HEADS AS THE INSTRUMENT WAS DESIGNED TO. IT WAS REPORTED THAT THE DEVICE WAS NO LONGER FUNCTIONAL, AND WAS SUBSEQUENTLY DISCARDED. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24895327 ↗
• 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 24094941 ↗
• 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 24094696 ↗
• 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 24094674 ↗
• MalfunctionDec 24, 2025Break; Break

  IT WAS REPORTED THAT THE TAPERED TRIALS WERE BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23888936 ↗
• 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, IP-02608988. DEVICE PROPERTY OF: NONE, DEVICE IN POSSESSION OF: NONE, IP-02608989. DEVICE PROPERTY OF: NONE, DEVICE IN POSSESSION OF: NONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23888095 ↗
• 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 23888092 ↗
• 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 23807738 ↗
• 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 23807697 ↗
• 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 23807677 ↗
• MalfunctionDec 2, 2025Break; Break

  IT WAS REPORTED THAT THE DEVICE BROKE WHILE PUTTING TRIAL ON STEM. SURGEON USED A HEAD BALL PUSHER AND A MALLET TO IMPACT THE TRIAL AND IT BROKE. ALL PARTS RETRIEVED AND NO INJURIES OCCURRED. NO DELAYS EITHER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23691549 ↗
• MalfunctionNov 10, 2025Material Deformation; Material Deformation

  REPORT 2 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 23508318 ↗
• MalfunctionOct 15, 2025Break; Break

  IT WAS REPORTED THAT PIECE WAS BROKEN DUE TO OVER IMPACTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23280993 ↗
• MalfunctionMar 10, 2025Break; Break

  IT WAS REPORTED THAT A MODULAR CATHCART TAPERED SPACER TRIAL BROKE INTO TWO PIECES. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21561916 ↗
• MalfunctionJan 3, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED DURING A HIP SURGERY ON (B)(6) 2024, THE MOD ENDO TRIAL SPACER WOULDN¿T FIT FLUSH INSIDE THE HEAD TRIAL. THE SURGEON TRIED CHANGING RINGS AND A DIFFERENT SIZE, BUT IT STILL DIDN'T FIT FLUSH. OTHER SPACERS WOULD FIT FLUSH. THERE WAS NO SURGICAL DELAY IN SURGERY. ALSO, THERE WERE NO ADVERSE EFFECTS FOR PATIENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21069036 ↗
• MalfunctionDec 12, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT SURGEON COULD NOT GET THE +0 UNIPOLAR HEAD TRIAL OFF THE 4/5 STD NECK TRIAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20912333 ↗
• MalfunctionNov 5, 2024Break; Break

  IT WAS REPORTED THAT THE TRIAL SPACER BROKE WHILE REMOVING IT FROM THE TRIAL HEAD AFTER SURGERY. ALL PIECES WERE RETRIEVED.

  Patient problems: Insufficient Information

  MAUDE report 20615019 ↗
• MalfunctionSep 11, 2024Break; Break

  IT WAS REPORTED THAT THE INSTRUMENT BROKE.

  Patient problems: Insufficient Information

  MAUDE report 20194572 ↗
• MalfunctionSep 11, 2024Break; Break

  IT WAS REPORTED THAT THE INSTRUMENT BROKE.

  Patient problems: Insufficient Information

  MAUDE report 20194286 ↗
• MalfunctionAug 21, 2024Break; Break

  IT WAS REPORTED THAT THE TRIAL SPACER BROKE INTO 2 PIECES WHILE TRIALING A UNIPOLAR HEAD. ALL PIECES WERE RETRIEVED, NOTHING WAS LEFT BEHIND IN THE PATIENT. THERE WAS NO INDICATION THE TRIAL WAS GOING TO BREAK. THIS DID NOT CAUSE A TIME DELAY. THIS ITEM NEEDS TO BE REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20022085 ↗
• MalfunctionJul 2, 2024Break; Break

  IT WAS REPORTED THAT INSTRUMENTS BROKE DURING THE CASE.

  Patient problems: Insufficient Information

  MAUDE report 19656029 ↗
• MalfunctionJun 7, 2024Break; Break

  THE DEVICE WAS REPORTED THAT THE TOP OF THE INSTRUMENT BROKE OFF. IT DID NOT HAPPEN IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19492351 ↗