PROSTALAC 1541-42-320Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10603295057857), received between Jul 12, 2024 and Apr 13, 2026 — classified as 8 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (4 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.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• 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 ALLEGATION AGAINST THE PRODUCT.

  Patient problems: Fluid Discharge

  MAUDE report 24844738 ↗
• InjuryJun 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED FOR A FRACTURE IN ACETABULUM. AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Bone Fracture(s)

  MAUDE report 22283816 ↗
• InjuryJan 15, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP HAD TO BE REVISED A SECOND TIME, WITHIN A TWENTY-FOUR HOUR PERIOD, BECAUSE IT HAD BECOME DISLOCATED. THE PATIENT'S HIP HAD BEEN INITIALLY REVISED THE PRIOR EVENING DUE TO INFECTION. DURING THAT SURGICAL PROCEDURE, THE PATIENT'S PRIMARY HIP IMPLANTS WERE REMOVED AND REPLACED BY PROSTALAC COMPONENTS (ANTIBIOTIC COATED STEM, POLYETHYLENE CUP, AND A METAL FEMORAL HEAD). UPON EXAMINATION OF THE PATIENT'S HIP DURING THE SECOND OPEN REVISION PROCEDURE, IT WAS DETERMINED THAT THE PROSTALAC STEM HAD ROTATED WITHIN THE PATIENT'S FEMUR, LIKELY CAUSED THE DISLOCATION. THE ROTATION OF THE STEM WAS DUE TO LOOSENESS, CAUSED BY AN UNRECOGNIZED FEMUR FRACTURE THAT LIKELY OCCURRED DURING THE INITIAL REVISION PROCEDURE. THE FRACTURE WAS REDUCED BY THE USE OF CABLES AND THE STEM WAS THEN FURTHER STABILIZED BY THE APPLICATION OF BONE CEMENT. A SHORTER FEMORAL HEAD, IN COMPARISON TO THE HEAD USED THE EVENING BEFORE. WAS APPLIED. THE HIP WAS THEN REDUCED AND PUT THROUGH A RANGE OF MOTION TO CHECK (VERIFY) ITS STABILITY. AFFECTED SIDE: RIGHT HIP. THIS REPORT CAPTURES PATIENT'S SECOND REVISION WHILE RELATED COMPLAINT (B)(4) CAPTURES THE 1ST REVISION DUE TO INFEC

  Patient problems: Joint Dislocation; Joint Laxity

  MAUDE report 21161679 ↗
• InjuryNov 20, 2024Loss of or Failure to Bond; Device Dislodged or Dislocated; Loss of or Failure to Bond; Device Dislodged or Dislocated

  ADDITIONAL INFORMATION WAS RECEIVED AND STATED NO SURGICAL DELAY.

  Patient problems: Joint Dislocation

  MAUDE report 20737920 ↗
• InjuryNov 1, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED DUE TO DISLOCATION. SURGEON REPLACED PROSTALAC CUP WITH A COMPETITOR CONSTRAINED CUP. HEAD WAS ALSO REPLACED. NO TIME LOST. DOI: ON (B)(6) 2024, DOR: ON (B)(6) 2024, AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 20591413 ↗
• InjuryOct 7, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY DUE TO DISLOCATION. CUP AND HEAD WERE EXPLANTED AND NEW CUP AND HEAD (WITH MODIFIED VERSION) WERE IMPLANTED. THERE WAS NO LOSS OF TIME.

  Patient problems: Joint Dislocation

  MAUDE report 20384840 ↗
• InjuryJul 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO PAIN. DOI: UNKNOWN, DOR: (B)(6) 2024, AFFECTED SIDE: RIGHT HIP SIDE.

  Patient problems: Pain

  MAUDE report 19733308 ↗