PROSTALAC 2541-55-000Recalls & reported problems
Depuy Orthopaedics, Inc. · PROSTALAC MOLD SIZE 5 145mm · Class 2 · Implant
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295129615), received between Jul 8, 2024 and Apr 2, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (1 report).
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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Break1
- Mechanical Problem1
- Naturally Worn1
- Scratched Material1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 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 24767400 ↗MalfunctionJul 8, 2024Mechanical Problem; Naturally Worn; Mechanical Problem; Naturally Worn
IT WAS REPORTED THAT THE EVENT DID NOT HAPPEN IN SURGERY. THE MOLDS WERE WORN AND THE THREADS WERE STRIPPED, SO THE NUTS WOULD NOT TIGHTEN ON.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19691105 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.