CEMENTRALIZER 1376-22-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10603295034469), received between Jun 10, 2019 and Aug 23, 2024 — classified as 6 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 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.

• InjuryAug 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  STUDY NO: (B)(6). CLINICAL ADVERSE EVENTS RECEIVED FOR INFECTION: DEEP, DEVICE AND PROCEDURE (RELATEDNESS). DEVICE RELATED: REMOTE POSSIBILITY. PROCEDURE RELATED: PROBABLY. DATE OF IMPLANT: (B)(6) 2024, DATE OF REVISION: (B)(6) 2024, DEVICE LOCATION: LEFT. TREATMENT/IMPACT: REVISION.

  Patient problems: Adhesion(s); Impaired Healing; Pain; Post Operative Wound Infection; Unspecified Infection

  MAUDE report 20052135 ↗
• InjuryJun 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  STUDY NO: DOTS CLINICAL ADVERSE EVENT RECEIVED FOR INFECTION. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2024. DATE REVISION: UNK (B)(6) 2024. DATE OF EVENT: (B)(6) 2024. (LEFT HIP), TREATMENT: REVISION; PRODUCTS REVISED UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 19537814 ↗
• InjurySep 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INSTABILITY, AND THE STEM, HEAD, AND LINER WERE REMOVED. IT WAS UNKNOWN IF THERE WAS ANY SURGICAL DELAY. DOI: (B)(6) 2012, DOR: (B)(6) 2023, AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Laxity

  MAUDE report 17817055 ↗
• InjuryMay 20, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAS NOW BEEN REVISED TO ADDRESS A CONFIRMED INFECTION WITH EXPLANTATION OF ALL PRODUCTS. THIS INCLUDING THE USE OF AN OPENING FEMORAL OSTEOTOMY TO FACILITATE REMOVAL OF THE FEMORAL STEM. AN ANTIBIOTIC SPACER WAS RE-IMPLANTED TO ADDRESS THE INFECTION. ALL DEVICES ARE CONSIDERED REPORTABLE, GIVEN THAT IT IS NOT POSSIBLE TO RULE-OUT THEIR POSSIBLE CONTRIBUTION, GIVEN THAT THEY PRESENT A SAFE HARBOR FOR INFECTIOUS MICROORGANISMS TO TAKE HOLD.

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

  MAUDE report 11855012 ↗
• InjuryNov 6, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INFECTION AND LOOSENING OF THE FEMORAL STEM AT THE CEMENT TO IMPLANT INTERFACE. COMPETITOR BONE CEMENT WAS USED. IT WAS CONVERTED FROM A HEMI TO A TOTAL HIP REPLACEMENT. NO SURGICAL DELAY NOTED. DOI: (B)(6) 2020, DOR: (B)(6) 2020, LEFT HIP.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10803625 ↗
• InjuryJun 10, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR DVTS BILATERALLY: VASCULAR - DVT. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS DEFINITELY NOT RELATED TO DEVICE AND POSSIBLY RELATED TO PROCEDURE. DOI: (B)(6) 2019; DOR: (B)(6) 2019 (PELVIC FRACTURE: CUP, LINER, AND HEAD REVISED); DOE: (B)(6) 2019; (RIGHT HIP). DEPUY HIP COMPONENTS PRESENT AT THE TIME OF THE AE: CATALOG ID: 101185000, LOT: 348034, DESCRIPTION: PROTRUSIO CAGE 48MM X 45MM RT. CATALOG ID: 122132048, LOT: J19U80, DESCRIPTION: PINNACLE ALTRX POLYETHYLENE ACETABULAR LINER NEUTRAL 32MM ID 48MM OD. CATALOG ID: 136521000, LOT: D18122792, DESCRIPTION: ARTICUL/EZE HEAD COCR 32MM +1. CATALOG ID: 545032500, LOT: 8719593, DESCRIPTION: DEPUY CMW 2 GENTAMICIN BONE CEMENT. CATALOG ID: 545032500, LOT: 8939042, DESCRIPTION: DEPUY CMW 2 GENTAMICIN BONE CEMENT. CATALOG ID: 3322020, LOT: 8885300, DESCRIPTION: SMART SET BONE CEMENT 20G. CATALOG ID: 101140020, LOT: J30C19, DESCRIPTION: SELF TAPPING SCREW 20MM. CATALOG ID: 101140020, LOT: J30C19, DESCRIPTION: SELF TAPPING SCREW 20MM. CATALOG ID: 101140015, LOT: 371070, DESCRIPTION: ROOF PILE SCREW 15MM. CATALOG ID: 101140025, LOT: HD7680, DESCRIPTION: ROOF PILE SCREW 25MM. CATALOG ID: 10

  Patient problems: Thrombosis

  MAUDE report 8682603 ↗