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DEPUY 2055-18-000Recalls & reported problems

Depuy (Ireland) · DEPUY FEMORAL HEAD SIZER 41/46mm · Class 1

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
8
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10603295084525), received between Sep 10, 2018 and May 18, 2023 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (4 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

Device problems

  • Material Deformation4
  • Naturally Worn2
  • Scratched Material2
  • Illegible Information1

Patient problems

  • No Clinical Signs, Symptoms or Conditions4
  • No Consequences Or Impact To Patient4

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

  • MalfunctionMay 18, 2023Scratched Material; Scratched Material

    IT WAS REPORTED THAT HEAD SIZERS PITTED NEED TO BE REPLACED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16952440 ↗
  • MalfunctionMay 18, 2023Scratched Material; Scratched Material

    IT WAS REPORTED THAT HEAD SIZERS PITTED NEED TO BE REPLACED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16952380 ↗
  • MalfunctionApr 18, 2022Naturally Worn; Illegible Information; Naturally Worn; Illegible Information

    IT WAS REPORTED THAT SIZERS FOR THE FEMORAL HEADS ARE FADED AND YOU CANNOT READ THEM. INSTRUMENTS ABOUT 10 YEARS OLD. WEAR AND TEAR.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 14137707 ↗
  • MalfunctionNov 4, 2021Naturally Worn; Naturally Worn

    IT WAS REPORTED THAT THE WRITING HAS FADED OFF. NO SURGICAL DELAY REPORTED. NO FURTHER INFORMATION RECEIVED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12751774 ↗
  • MalfunctionSep 10, 2018Material Deformation; Material Deformation

    MDR STAFF HAS INDICATED THAT PRODUCT IS WORN AND DAMAGED. PRODUCT IS NO LONGER FUNCTIONAL AND A REPLACEMENT IS REQUIRED. NO FURTHER INFORMATION IS AVAILABLE. PLEASE SEND REPLACEMENT DIRECT TO THE FOLLOWING ADDRESS: (B)(6). N/C PO TO FOLLOW. PC WILL BE UPDATED ACCORDINGLY. 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 7862518 ↗
  • MalfunctionSep 10, 2018Material Deformation; Material Deformation

    MDR STAFF HAS INDICATED THAT PRODUCT IS WORN AND DAMAGED. PRODUCT IS NO LONGER FUNCTIONAL AND A REPLACEMENT IS REQUIRED. NO FURTHER INFORMATION IS AVAILABLE. PLEASE SEND REPLACEMENT DIRECT TO THE FOLLOWING ADDRESS: (B)(4). (B)(4). N/C PO TO FOLLOW. PC WILL BE UPDATED ACCORDINGLY. 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 7862407 ↗
  • MalfunctionSep 10, 2018Material Deformation; Material Deformation

    MDR STAFF HAS INDICATED THAT PRODUCT IS WORN AND DAMAGED. PRODUCT IS NO LONGER FUNCTIONAL AND A REPLACEMENT IS REQUIRED. NO FURTHER INFORMATION IS AVAILABLE. PLEASE SEND REPLACEMENT DIRECT TO THE FOLLOWING ADDRESS: (B)(6). N/C PO TO FOLLOW. PC WILL BE UPDATED ACCORDINGLY. 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 7862338 ↗
  • MalfunctionSep 10, 2018Material Deformation; Material Deformation

    MDR STAFF HAS INDICATED THAT PRODUCT IS WORN AND DAMAGED. PRODUCT IS NO LONGER FUNCTIONAL AND A REPLACEMENT IS REQUIRED. NO FURTHER INFORMATION IS AVAILABLE. PLEASE SEND REPLACEMENT DIRECT TO THE FOLLOWING ADDRESS: (B)(6). 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 7862321 ↗

Other TEMPLATE devices

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Sources and updates

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