PROSTALAC 2541-88-000Recalls & reported problems
Depuy Orthopaedics, Inc. · PROSTALAC LONG STEM MOLD - RIGHT SIZE 3 240mm · Class 2 · Implant
All models of PROSTALAC (21)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10603295129653), received between Oct 23, 2023 and Apr 2, 2026 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Break” (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
- Break3
- Device-Device Incompatibility1
- Difficult to Open or Close1
- Mechanical Jam1
- Mechanical Problem1
- Naturally Worn1
- Scratched Material1
Patient problems
- No Clinical Signs, Symptoms or Conditions5
Recent adverse event reports
The 5 most recent of 5 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 REFUSED TO RESTERILIZE THE INSTRUMENTS ANY LONGER DUE THE WEAR AND TEAR OF THE METAL. THERE WERE MANY CHIPS AND SCRATCHES ON THEM, WHICH COMPROMISED PATIENT SAFETY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24767996 ↗MalfunctionJan 28, 2026Break
IT WAS REPORTED THAT THE EVENT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24199439 ↗MalfunctionJan 20, 2026Break; Mechanical Jam
IT WAS REPORTED THAT THE PROSTALAC MOLD BOLT CAME OFF AND THE POSITIONERS FOR CENTERING WERE NOT ON.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24117623 ↗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 19691207 ↗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 17989196 ↗
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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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