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
- ATTUNE 2544-01-014Depuy (Ireland) · TEMPLATE802 reports
- ATTUNE 2545-00-546Depuy (Ireland) · TEMPLATE1 recall301 reports
- 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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