PROSTALAC 2541-83-165Recalls & reported problems
Depuy Orthopaedics, Inc. · PROSTALAC LONG STEM MOLD - INSERT 165mm · Class 2
All models of PROSTALAC (21)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10603295129639), received between Sep 30, 2024 and Apr 2, 2026 — classified as 7 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 Incompatibility2
- Material Deformation2
- Naturally Worn1
- No Apparent Adverse Event1
- Scratched Material1
Patient problems
- No Clinical Signs, Symptoms or Conditions7
Recent adverse event reports
The 7 most recent of 7 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 24767403 ↗MalfunctionJan 15, 2026Break
IT WAS REPORTED THAT THE LONG INSERT BULLET FOR THE PROSTALAC MOLD WAS DAMAGED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24087570 ↗MalfunctionNov 17, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT PROSTALAC LONG STEM MOLD INSERT DOES NOT FIT PROPERTY IN MOLD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23572201 ↗MalfunctionJul 30, 2025Break; Break
IT WAS REPORTED THAT THE BULLET TIP WAS CHIPPED WITH SHARP EDGES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22663472 ↗MalfunctionJul 29, 2025Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation
IT WAS REPORTED THAT THE BULLET WARPED AND WILL NOT FIT IN THE MOLD. THE EVENT DID NOT HAPPEN DURING A SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22641572 ↗MalfunctionMar 5, 2025No Apparent Adverse Event; No Apparent Adverse Event
THE DEVICES WERE REPORTED FOR AN UNKNOWN REASON/MALFUNCTION. IT DIDNT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21525944 ↗MalfunctionSep 30, 2024Material Deformation; Naturally Worn; Material Deformation; Naturally Worn
IT WAS REPORTED THAT ON (B)(6) 2024, THE LONG INSERT FOR MOLD IS WORN AND HAS METAL BURRS ON IT. THE EVENT DID NOT HAPPEN DURING A SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20334602 ↗
Other BONE CEMENT devices
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- NA 3312-040Depuy (Ireland) · BONE CEMENT4 deaths258 reports
- NA 3332-040Depuy (Ireland) · BONE CEMENT4 deaths197 reports
- NA 5450-31-500Depuy (Ireland) · BONE CEMENT2 deaths168 reports
- NA 5450-32-500Depuy (Ireland) · BONE CEMENT1 death150 reports
- PALACOS® MV pro 80Heraeus Medical GmbH · Bone Cement2 recalls1 report
- PALACOS® R pro 80Heraeus Medical GmbH · Bone Cement2 recalls1 report
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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