PROSTALAC 2541-52-000Recalls & reported problems
Depuy Orthopaedics, Inc. · PROSTALAC MOLD SIZE 2 125mm · Class 2 · Implant
All models of PROSTALAC (21)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10603295129585), received between Oct 23, 2023 and Apr 2, 2026 — classified as 6 malfunctions.
The most frequently reported specific device problem is “Device-Device Incompatibility” (3 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Device-Device Incompatibility3
- Scratched Material2
- Break1
- Contamination /Decontamination Problem1
- Difficult to Open or Close1
- Material Deformation1
Patient problems
- No Clinical Signs, Symptoms or Conditions6
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 2, 2026Break; Scratched Material
IT WAS REPORTED THAT THE STERILE PROCESSING DEPARTMENT REFUSES TO RESTERILIZE THE INSTRUMENTS ANY LONGER DUE THE WEAR AND TEAR OF THE METAL. MANY CHIPS AND SCRATCHES ON THEM COMPROMISING PATIENT SAFETY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24767393 ↗MalfunctionApr 1, 2025Device-Device Incompatibility; Scratched Material; Device-Device Incompatibility; Scratched Material
IT WAS REPORTED THAT THE CEMENT STUCK TO PROSTALAC MOLD WHEN TRYING TO RELEASE THE STEM. AFTER CASE IT WAS NOTICED THAT INSIDE OF MOLD WAS PITTED AND NOT SMOOTH. THERE WAS NO DELAY OR EXTENDED SURGICAL TIME. CASE WAS COMPLETED WITHOUT FURTHER INCIDENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21739169 ↗MalfunctionOct 11, 2024Device-Device Incompatibility; Device-Device Incompatibility
ADDITIONAL INFORMATION RECEIVED STATES THAT THERE WAS NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20428083 ↗MalfunctionOct 7, 2024Material Deformation; Material Deformation
IT WAS REPORTED THAT THE MOLD HAS SHARP METAL BURR ON THE INSIDE. THE EVENT DID NOT HAPPEN DURING SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20383333 ↗MalfunctionJul 1, 2024Contamination /Decontamination Problem; Contamination /Decontamination Problem
IT WAS REPORTED STAFF WAS UNABLE TO REMOVE CEMENT AROUND BOLTS. MULTIPLE ATTEMPTS WERE MADE. NO LONGER ABLE TO STERILIZE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19643275 ↗MalfunctionOct 23, 2023Device-Device Incompatibility; Difficult to Open or Close; Device-Device Incompatibility; Difficult to Open or Close
IT WAS REPORTED THAT THE PROSTALAC MOLDS DON'T FIT TOGETHER PROPERLY AND THE PROSTALAC NUTS ARE STRIPPED. THE EVENT DID NOT HAPPEN DURING SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17988493 ↗
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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 13, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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