CEMENTRALIZER 1376-21-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10603295034452), received between Sep 19, 2017 and Sep 20, 2024 — classified as 1 death, 15 injuries.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (2 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• InjurySep 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION SURGEON PULLED IMPLANTS AND PUT SPACER IN. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 20270813 ↗
• InjuryDec 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS INFECTED AND BOARDED FOR A HIP IRRIGATION AND DEBRIDEMENT (I&D) WITH HEAD SWAP. WHILE DISLOCATING THE FEMUR THE DOCTOR NOTICED THE STEM MOVING. THE STEM WAS LOOSE. CEMENT MANTEL WAS REMOVED AND A NEW HEMI WAS PUT IN AFTER A WASH OUT WAS PERFORMED. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 18277216 ↗
• InjuryNov 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD PAIN. BIPOLAR WAS CONVERTED TO TOTAL. IT WAS UNKNOWN ABOUT SURGICAL DELAY. DOI: (B)(6) 2021. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT.

  Patient problems: Pain

  MAUDE report 18097238 ↗
• InjuryMay 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A HEMI DONE IN (B)(6) 2021, PATIENT IS INFECTED. REMOVED IMPLANTS AND CEMENTED IN ANOTHER HEMI WITH ANTIBIOTIC IMPREGNATED CEMENT. I HAVE NO OTHER INFORMATION. THERE IS NO REPORTED LOOSENING. NO SURGICAL DELAY REPORTED. DOI: (B)(6) 2021. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 14307258 ↗
• InjuryOct 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PPF AND MEDICAL RECORDS RECEIVED. PPF ALLEGED DISLOCATION WITH CLOSED REDUCTION. DOI: (B)(6) 2010. DOR: NOT REPORTED. (RIGHT HIP).

  Patient problems: Pain; Scar Tissue; Unspecified Infection

  MAUDE report 12597799 ↗
• InjuryAug 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS RECEIVED. AFTER REVIEW OF MEDICAL RECORDS, IT WAS DECIDED THAT A NEW COMPLAINT WILL BE CREATED IN ORDER TO CAPTURE THE REPORTED ACUTE BLOOD LOSS ANEMIA AND 2 UNITS PRBC THAT WAS GIVEN ON (B)(6) 2013. DOI: (B)(6) 2013, DOR: (B)(6) 2013, RIGHT HIP.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 12363701 ↗
• InjuryFeb 17, 2021Adverse Event Without Identified Device or Use Problem

  AD 29 JAN 2021: UNFILED CLAIM AND THE MEDICAL RECORD RECEIVED. AFTER REVIEW OF THE MEDICAL RECORDS, THE PATIENT WAS REVISED TO ADDRESS RIGHT HIP INFECTION AND SEVERE METALLOSIS WITH NONVIABLE INNOMINATE BONE, NONVIABLE PSOAS HIP ADDUCTORS, AND ABDUCTORS, AND STATUS POST OSTEOMYELITIS INCLUDING FUNGAL OSTEOMYELITIS. OPERATIVE NOTE REPORTED SEVERE SOFT TISSUE AND BONE NECROSIS. ON (B)(6) 2020, THE PATIENT UNDERWENT HIP REDUCTION DUE TO DISLOCATION, HIP PAIN, AND ATRIAL FIBRILLATION. THE PATIENT UNDERWENT A SECOND REVISION ON (B)(6) 2020, WITH THE NON-DEPUY PRODUCT INVOLVED. DOI: (B)(6) 2020. DOR: (B)(6) 2020. RIGHT HIP (THIRD REVISION). PLEASE SEE PC (B)(4) THAT CAPTURED THE FIRST REVISION.

  Patient problems: Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Arrhythmia; Distress; Foreign Body Reaction; Joint Laxity; Loss of Range of Motion; Necrosis; Pain; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 11339049 ↗
• InjuryMay 28, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR VASCULAR - PULMONARY EMBOLISM. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS DEFINITELY NOT RELATED TO DEVICE AND IS POSSIBLY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2020. DATE OF EVENT (ONSET): (B)(6) 2020; (RIGHT HIP).

  Patient problems: No Code Available; Pulmonary Embolism

  MAUDE report 10096474 ↗
• InjuryMar 27, 2020Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE PATIENT HAD DISLOCATION ISSUES, AFTER INCISION THE DOCTOR FOUND THE STEM TO BE LOOSE. ORIGINAL IMPLANT DATE UNKNOWN. DOI: UNKNOWN. DOR: (B)(6) 2020, AFFECTED SITE: LEFT HIP.

  Patient problems: No Code Available

  MAUDE report 9890147 ↗
• 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 9342703 ↗
• InjuryApr 3, 2019Loss of or Failure to Bond; Loss of or Failure to Bond

  PPF ALLEGES DISLOCATION AND LOOSENING OF STEM AFTER FIRST REVISION. DOI: (B)(6) 2009, DOR: NONE REPORTED, (RIGHT HIP).

  Patient problems: Inadequate Osseointegration

  MAUDE report 8478283 ↗
• InjuryJan 24, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LITIGATION ALLEGES THAT THE PATIENT SUFFERS FROM PAIN, SWELLING, INFECTION, AND FRACTURE. UPDATE AD 06 JUN 2018: RECEIPT OF PPF AND STICKER SHEETS. IN ADDITION TO WHAT WAS PREVIOUSLY ALLEGED, PPF ALLEGES DISLOCATION. PATIENT IS DECEASED HOWEVER THERE IS NO INFORMATION PROVIDED ABOUT THE REASON AND DATE OF DEATH.

  Patient problems: No Code Available; Pain; Swelling; Unspecified Infection

  MAUDE report 8273282 ↗
• InjuryDec 5, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR FOOT DROP.

  Patient problems: No Code Available

  MAUDE report 8132959 ↗
• InjuryOct 9, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS HIP PAIN.

  Patient problems: No Code Available; Pain

  MAUDE report 7946384 ↗
• InjurySep 28, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PENDING PRODUCT LIABILITY, CUSTOMER ALLEGES INFECTION AFTER FIRST REVISION.

  Patient problems: Adhesion(s); Chills; Diaphoresis; Loss of Range of Motion; No Code Available; Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 7919773 ↗
• DeathSep 19, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT AFTER IMPLANTING THE REVISION PRODUCTS, THE PATIENT WAS CLOSED UP AND BEGAN EXPERIENCING PROBLEMS. THE PATIENT DIED IN ROOM. THE SURGEON LATER STATED THAT IT WAS PROBABLY DUE TO FAT EMBOLISM. COMPETITOR CEMENT WAS REPORTED TO BE USED DURING THE REVISION.

  Patient problems: Death; Embolism

  MAUDE report 6876365 ↗