PROSTALACRecalls & reported problems across all models

We found 21 models of PROSTALAC by Depuy Orthopaedics, Inc. in the FDA's device registry (GUDID). Together they are named in 79 adverse event reports in the FDA's MAUDE database, received between Sep 13, 2017 and Jul 30, 2026 — classified as 20 injuries, 59 malfunctions.

The most frequently reported specific device problem is “Break” (23 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported PROSTALAC problems

PROSTALAC models

21 models, most reported first. Each model has its own page with its reports, recalls and device details.

• PROSTALAC 2541-43-000

  ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
  11 reports
• PROSTALAC 1541-42-320

  BONE CEMENT
  8 reports
• PROSTALAC 1541-06-000

  Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented
  7 reports
• PROSTALAC 2541-83-165

  BONE CEMENT
  7 reports
• PROSTALAC 2541-52-000

  BONE CEMENT, ANTIBIOTIC
  6 reports
• PROSTALAC 2541-88-000

  BONE CEMENT, ANTIBIOTIC
  5 reports
• PROSTALAC 2541-53-000

  BONE CEMENT, ANTIBIOTIC
  4 reports
• PROSTALAC 2541-83-000

  BONE CEMENT
  4 reports
• PROSTALAC 2541-83-215

  Prosthesis, hip, hemi-, femoral, metal
  4 reports
• PROSTALAC 2541-41-000

  ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
  3 reports
• PROSTALAC 2541-44-000

  ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
  3 reports
• PROSTALAC 2541-91-320

  TEMPLATE
  3 reports
• PROSTALAC 1541-18-000

  Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented
  2 reports
• PROSTALAC 1541-38-000

  Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented
  2 reports
• PROSTALAC 2541-51-000

  Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented
  2 reports
• PROSTALAC 2541-54-000

  Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented
  2 reports
• PROSTALAC 2541-55-000

  BONE CEMENT, ANTIBIOTIC
  2 reports
• PROSTALAC 1541-01-000

  Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented
  1 report
• PROSTALAC 1541-23-000

  Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented
  1 report
• PROSTALAC 2541-23-000

  TEMPLATE
  1 report
• PROSTALAC 2541-42-000

  ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
  1 report

Recent PROSTALAC adverse event reports

The 15 most recent reports across all models, 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 ↗
• MalfunctionJul 2, 2026Crack; Material Deformation

  IT WAS REPORTED THE PROSTALAC HEAD IS CRACKED AND STRIPPED AND NEEDS TO BE REPLACED. IT WAS NOTED THE DEVICE IS STILL IN ONE PIECE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25690433 ↗
• InjuryApr 13, 2026Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED: WHAT IS THE AFFECTED SIDE INVOLVED IN THIS EVENT? LEFT OR RIGHT? RIGHT SIDE.

  Patient problems: Insufficient Information

  MAUDE report 24861454 ↗
• InjuryApr 10, 2026Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED AND STATES THAT THERE WAS NO ALLEGATIONS AGAINST THE PRODUCT.

  Patient problems: Fluid Discharge

  MAUDE report 24845076 ↗
• InjuryApr 10, 2026Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED AND STATES THAT THERE WAS NO ALLEGATION AGAINST THE PRODUCT.

  Patient problems: Fluid Discharge

  MAUDE report 24844738 ↗
• 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 ↗
• 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 24778815 ↗
• 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 ↗
• 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 ↗
• 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 24767432 ↗
• 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 24767405 ↗
• 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 ↗
• 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 ↗
• 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 24767398 ↗
• 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 24767396 ↗

Other Depuy Orthopaedics, Inc. products

• PINNACLE ALTRX98 models · 5,631 reports
• BIOLOX DELTA40 models · 4,995 reports · 1 recall
• PINNACLE182 models · 4,587 reports
• QUICKSET7 models · 3,790 reports
• PINNACLE POROCOAT38 models · 2,112 reports
• SUMMIT POROCOAT20 models · 1,646 reports
• PINNACLE GRIPTION57 models · 1,608 reports
• DURALOC93 models · 1,262 reports