PROSTALAC 2541-53-000Recalls & reported problems
Depuy Orthopaedics, Inc. · PROSTALAC MOLD SIZE 3 130mm · Class 2 · Implant
All models of PROSTALAC (21)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10603295129592), received between Jun 28, 2024 and Jul 30, 2026 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Contamination /Decontamination Problem” (2 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
- Contamination /Decontamination Problem2
- Break1
- Device-Device Incompatibility1
- Naturally Worn1
- Scratched Material1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 30, 2026Contamination /Decontamination Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50085606 ↗MalfunctionApr 3, 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 24778817 ↗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 19643285 ↗MalfunctionJun 28, 2024Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn
IT WAS REPORTED THAT PROSTALAC MOLDS WERE VERY WORN AND THE THREADS WERE STRIPPED, SO THE NUTS WERE UNABLE TO BE SCREWED ON. IT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19639187 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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