CEMENTRALIZER 1376-47-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10603295034551), received between Dec 20, 2017 and Dec 4, 2025 — classified as 6 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Disinfection Or Sterilization Issue” (1 report).

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.

• InjuryDec 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT BIPOLAR REMOVED BECAUSE OF INFECTION. AFFECTED SIDE-LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 23716269 ↗
• InjuryMar 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RIGHT HEMI-ARTHROPLASTY REVISION TO PROSTALAC BECAUSE OF INFECTION. NO ADVERSE EFFECTS OR SURGICAL DELAYS. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 21576733 ↗
• InjuryJan 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE HIP REVISION OF CEMENTED BIPOLAR CONSTRUCT DUE TO INSTABILITY AND DISLOCATION. STEM WAS REMOVED AND A NEW STEM WAS CEMENTED IN PLACE. THIS WAS IMPLANTED WITH A COMPETITORS DUAL MOBILITY CUP CONSTRUCT. DOI: (B)(6) 2020 - DOR: (B)(6) 2021 (LEFT HIP).

  Patient problems: Joint Laxity

  MAUDE report 11237935 ↗
• InjuryJan 2, 2020Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  IT WAS REPORTED THAT THE PATIENTS LEFT HIP WAS REVISED DUE TO INFECTION AND AN ANTIBIOTIC SPACER WAS PLACED.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9538080 ↗
• InjuryNov 19, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION DUE TO INFECTION.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9343015 ↗
• InjuryMay 13, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION AND LOOSENING AT THE CEMENT TO IMPLANT INTERFACE. THERE WAS ALSO REMOVAL OF IMPLANTS, WASH OUT AND RE-IMPLANTATION. DOI: (B)(6) 2019; DOR: (B)(6) 2019, LEFT HIP.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8604796 ↗
• MalfunctionDec 20, 2017Device Disinfection Or Sterilization Issue; Device Disinfection Or Sterilization Issue

  IT WAS STATED THAT STERILIZATION WAS COMPROMISED DUE TO HAIR BEING FOUND ON IMPLANTS. DID NOT NOTICE WHICH PACKAGE AT CAME FROM BECAUSE IMPLANTS HAD BEEN ASSEMBLED.

  Patient problems: No Consequences Or Impact To Patient; Not Applicable

  MAUDE report 7135316 ↗