CEMENTRALIZER 1376-48-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295034568), received between Nov 13, 2020 and Mar 11, 2022 — classified as 3 injuries.

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMar 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SURGEON DID AN IMPLANT EXCHANGE DUE TO INFECTION. THE SURGEON IMPLANTED A PROSTALAC IMPLANT. DOI: (B)(6) 2021; DOR: (B)(6) 2022; AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 13731891 ↗
• InjuryApr 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED DUE TO INFECTION. ALL COMPONENTS WERE REMOVED AND A CEMENT SPACER WAS PLACED. THE PATIENT'S ORIGINAL TOTAL HIP WAS DONE (B)(6) 2020 AND HE HAD AN I&D WASHOUT, HEAD LINER EXCHANGE, ON (B)(6) 2020. DOI: (B)(6) 2020; DOR: (B)(6) 2021; AFFECTED SIDE: LEFT HIP.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11672343 ↗
• InjuryNov 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO PAIN. DOI: (B)(6) 2019. DOR: (B)(6) 2020; AFFECTED: RIGHT HIP.

  Patient problems: No Code Available; Pain

  MAUDE report 10836802 ↗