CEMENTRALIZER 1376-20-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10603295034445), received between Dec 18, 2017 and Sep 11, 2025 — classified as 6 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjurySep 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. DOI: UNKNOWN, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Pain

  MAUDE report 23030726 ↗
• InjuryFeb 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY NO: (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR INFECTION - SUPERFICIAL. EVENT IS SERIOUS AND IS CONSIDERED MILD. EVENT IS POSSIBLY RELATED TO PROCEDURE. EVENT IS NOT RELATED TO DEVICE. DATE OF IMPLANT: (B)(6) 2023 DATE OF EVENT: (B)(6) 2024 (RIGHT HIP) TREATMENT: IRRIGATION AND DEBRIDEMENT

  Patient problems: Unspecified Infection

  MAUDE report 18694400 ↗
• InjuryDec 4, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PFS, PPF, IMPLANT RECORD AND MEDICAL RECORDS RECEIVED. PFS HAS NO ALLEGATION PPF ALLEGES INFECTION. AFTER REVIEW OF MEDICAL RECORDS, PATIENT WAS REVISED TO ADDRESS INFECTED RIGHT HIP ARTHROPLASTY. OPERATIVE NOTES REPORTED OF SOME SUPERFICIAL FLUID AND NECROTIC DEBRIS. THE CUP CAME OUT WITHOUT ANY DIFFICULTY AND THE STEM WAS GROSSLY LOOSE. DOI: (B)(6) 2015 (HEAD & LINER). DOI: (B)(6) 2004 (STEM, CUP, SCREWS, CENTRALIZER, CEMENT, ELIMINATOR). DOR: (B)(6) 2016 RIGHT HIP 7TH REVISION. PLEASE SEE PC-(B)(4) RIGHT HIP 1ST REVISION. PC-(B)(4) RIGHT HIP 2ND REVISION. PC-(B)(4) RIGHT HIP 3RD REVISION. PC-(B)(4) RIGHT HIP 4TH REVISION. PC-(B)(4) RIGHT HIP 5TH REVISION. PC-(B)(4) RIGHT HIP 6TH REVISION.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9410804 ↗
• InjuryNov 19, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION DUE TO INFECTION. DOI: UNKNOWN - DOR: UNKNOWN (RIGHT HIP).

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9342463 ↗
• InjuryMar 6, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS INFECTION AND LOOSENING OF THE STEM AT CEMENT TO IMPLANT INTERFACE. ALL PARTS WHERE REMOVED. COMPETITOR STEM WAS USED. DOI: (B)(6) 2018. DOR: (B)(6) 2019. RIGHT HIP.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8394635 ↗
• InjuryDec 18, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  DER STATES PT HAD ORIGINAL SURGERY (B)(6) 2017. ON (B)(6) 2017 PATIENT HAD HEAD AND LINER EXCHANGE FOR INFECTION. PATIENT STILL INFECTED SO SURGEON REMOVED ALL COMPONENTS AND PUT IN ANTIBIOTIC SPACER. IT ALSO STATE THAT PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE FEMORAL STEM AT THE CEMENT TO IMPLANT INTERFACE. UNKNOWN CEMENT IS USED. DOI: (B)(6) 2017; DOR: (B)(6) 2017; HEAD AND LINER: (B)(6) 2017; LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 7125127 ↗