PROSTALAC 2541-83-215Recalls & reported problems
Depuy Orthopaedics, Inc. · PROSTALAC LONG STEM MOLD - INSERT 215mm · Class 2
All models of PROSTALAC (21)
Data updated Oct 18, 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 10603295129646), received between May 6, 2025 and Apr 2, 2026 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Device-Device Incompatibility” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Device-Device Incompatibility2
- Material Deformation2
- Break1
- Contamination /Decontamination Problem1
- 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.
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 MANY CHIPS AND SCRATCHES ON THEM, WHICH COMPROMISED PATIENT SAFETY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24767956 ↗MalfunctionJul 28, 2025Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation
IT WAS REPORTED THAT THE BULLET WARPED AND WILL NOT FIT IN MOLD. IT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22631984 ↗MalfunctionJul 28, 2025Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation
IT WAS REPORTED THAT BULLET WARPED AND WILL NOT FIT IN MOLD. IT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22629747 ↗MalfunctionMay 6, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem
IT WAS REPORTED THAT INSERT INDENT HAS BECOME FILLED WITH CEMENT THAT WAS UNABLE TO BE REMOVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21969272 ↗
Other Prosthesis, hip, hemi-, femoral, metal devices
- UHR UH1-48-28Howmedica Osteonics Corp. · Prosthesis, hip, hemi-, femoral, metal2 recalls3 reports
- "UNITED" USTAR II Knee System 2515-3111United Orthopedic Corp. · Prosthesis, Hip, Hemi-, Femoral, Metal2 recalls0 reports
- "UNITED" USTAR II Knee System 2515-3213United Orthopedic Corp. · Prosthesis, Hip, Hemi-, Femoral, Metal2 recalls0 reports
- STAGEONE 431207Biomet Orthopedics, LLC · Prosthesis, hip, hemi-, femoral, metal2 recalls0 reports
- "UNITED" USTAR II Knee System 2515-3115United Orthopedic Corp. · Prosthesis, Hip, Hemi-, Femoral, Metal2 recalls0 reports
- ACTIS 101011050Depuy (Ireland) · Prosthesis, hip, hemi-, femoral, metal73 reports
- UHR UH1-46-26Howmedica Osteonics Corp. · Prosthesis, hip, hemi-, femoral, metal1 recall11 reports
- UHR UH1-45-26Howmedica Osteonics Corp. · Prosthesis, hip, hemi-, femoral, metal1 recall11 reports
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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