PROSTALAC 1541-06-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10603295057789), received between Nov 5, 2024 and May 8, 2025 — classified as 6 injuries, 1 malfunction.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 8, 2025Corroded; Corroded

  THAYER SCHOOL OF ENGINEERING AT DARTMOUTH FIRST REPORT OF RETRIEVALS FOR STATEMENT OF WORK 10 FOR Q1 OF 2025. DARTMOUTH IS THE RESEARCH LOCATION, AND NOT THE FACILITY OF PLACEMENT. A DEPUY SYNTHES IMPLANT WAS REVISED AND REVIEWED FOR ANALYSIS. REASON FOR REVISION: REMOVAL OF PROSTALAC SPACER AFTER INFECTION TREATMENT. REIMPLANTATION OF FINAL IMPLANTS. AT REMOVAL THE FEMORAL HEAD SHOWED CORROSION. AT REMOVAL THE ACETABULAR LINER SHOWED MINOR YELLOWING.

  Patient problems: Unspecified Infection

  MAUDE report 21987161 ↗
• InjuryMay 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THAYER SCHOOL OF ENGINEERING AT DARTMOUTH FIRST REPORT OF RETRIEVALS FOR STATEMENT OF WORK 10 FOR Q1 OF 2025. DARTMOUTH IS THE RESEARCH LOCATION, AND NOT THE FACILITY OF PLACEMENT. A DEPUY SYNTHES IMPLANT WAS REVISED AND REVIEWED FOR ANALYSIS REASON FOR REVISION: REVISION DUE TO PERIPROSTHETIC FEMUR FRACTURE.

  Patient problems: Limb Fracture

  MAUDE report 21981444 ↗
• InjuryMay 7, 2025Loss of or Failure to Bond; Migration; Loss of or Failure to Bond; Migration

  "THAYER SCHOOL OF ENGINEERING AT DARTMOUTH FIRST REPORT OF RETRIEVALS FOR STATEMENT OF WORK 10 FOR Q1 OF 2025. DARTHMOUTH IS THE RESEARCH LOCATION, AND NOT THE FACILITY OF PLACEMENT. A DEPUY SYNTHES IMPLANT WAS REVISED AND REVIEWED FOR ANALYSIS. REASON FOR REVISION: REVISION DUE TO LOOSE AND MIGRATED PROSTALAC STEM AND PAIN.

  Patient problems: Pain

  MAUDE report 21978294 ↗
• InjuryFeb 10, 2025Adverse 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 PERI PROSTHETIC FRACTURE. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED FOR REPORTING. NO FURTHER INFORMATION WAS PROVIDED. DOI; UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT HIP.

  Patient problems: Limb Fracture

  MAUDE report 21343836 ↗
• InjuryJan 23, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT PATIENT FELL AND NEEDED REVISION OF A PROSTALAC STEM/LINER AND PLACEMENT OF ANOTHER PROSTALAC. THE FALL FRACTURED BONE AND LOOSENED THE CUP AND STEM. THE PRODUCTS NEEDED TO BE REVISED FOR STABILITY PURPOSES. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Fall; Joint Laxity; Limb Fracture

  MAUDE report 21217499 ↗
• InjuryJan 15, 2025Loss of or Failure to Bond; Migration; Loss of or Failure to Bond; Migration

  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: Inadequate Osseointegration; Joint Laxity; Limb Fracture

  MAUDE report 21162036 ↗
• InjuryNov 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO PERIO PROSTHETIC FRACTURE. THERE WAS NO DELAY IN CASE. DOI: UNKNOWN DOR: (B)(6) 2024 AFFECTED SIDE: UNKNOWN DOI: UNKNOWN DOR: (B)(6) 2024 AFFECTED SIDE: UNKNOWN.

  Patient problems: Limb Fracture

  MAUDE report 20611160 ↗