CEMENTRALIZERRecalls & reported problems across all models
Depuy (Ireland) · 8 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 44
- Deaths reported
- 1
- Injuries reported
- 41
- Recalls
- 0
We found 8 models of CEMENTRALIZER by Depuy (Ireland) in the FDA's device registry (GUDID). Together they are named in 44 adverse event reports in the FDA's MAUDE database, received between Sep 19, 2017 and Dec 4, 2025 — classified as 1 death, 41 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported CEMENTRALIZER problems
Device problems
- Adverse Event Without Identified Device or Use Problem38
- Insufficient Device Problem Information2
- Loss of or Failure to Bond2
- Delivered as Unsterile Product1
- Device Disinfection Or Sterilization Issue1
- No Apparent Adverse Event1
Patient problems
- Unspecified Infection26
- No Code Available17
- Pain10
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available4
- Adhesion(s)3
- Joint Laxity3
- Loss of Range of Motion2
- No Consequences Or Impact To Patient2
CEMENTRALIZER models
8 models, most reported first. Each model has its own page with its reports, recalls and device details.
- CEMENTRALIZER 1376-21-000Prosthesis, hip, semi-constrained, metal/polymer, cemented1 death16 reports
- CEMENTRALIZER 1376-47-000Prosthesis, hip, semi-constrained, metal/polymer, cemented7 reports
- CEMENTRALIZER 1376-20-000Prosthesis, hip, semi-constrained, metal/polymer, cemented6 reports
- CEMENTRALIZER 1376-22-000Prosthesis, hip, semi-constrained, metal/polymer, cemented6 reports
- CEMENTRALIZER 1376-46-000Prosthesis, hip, semi-constrained, metal/polymer, cemented3 reports
- CEMENTRALIZER 1376-48-000Prosthesis, hip, semi-constrained, metal/polymer, cemented3 reports
- CEMENTRALIZER 1376-38-000Prosthesis, hip, semi-constrained, metal/polymer, cemented2 reports
- CEMENTRALIZER 1376-37-000Prosthesis, hip, semi-constrained, metal/polymer, cemented1 report
Recent CEMENTRALIZER adverse event reports
The 15 most recent reports across all models, 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 ↗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 ↗InjuryJun 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION IN THEIR HIP. SURGEON REMOVED EXISTING IMPLANTS AND PUT IN A PROSTALAC HIP SPACER. DOI: (B)(6) 2022. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.
Patient problems: Unspecified Infection
MAUDE report 22215137 ↗InjuryJun 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE STAGE 2 REVISION DUE TO INFECTION. THERE WAS NO ISSUE WITH PRODUCTS AND NO TIME WASTED DUE TO PRODUCTS. DOI: (B)(6) 2024. DOR: UNKNOWN. AFFECTED SIDE: RIGHT HIP.
Patient problems: Unspecified Infection
MAUDE report 22122110 ↗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 ↗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 ↗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 ↗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 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 ↗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 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 ↗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 ↗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 ↗
Other Depuy (Ireland) products
All Depuy (Ireland) devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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