C-STEM 9611-64-000Recalls & reported problems
Depuy (Ireland) · C-STEM Stem SIZE 4 9/10 TAPER CEMENTED · Class 2 · Implant
All models of C-STEM (30)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295235217), received between Jun 29, 2017 and Jul 19, 2022 — classified as 2 injuries, 1 malfunction.
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
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Insufficient Device Problem Information1
- Migration1
Patient problems
- Bone Fracture(s)1
- No Information1
- Unspecified Infection1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 19, 2022Migration; Migration
IT WAS REPORTED THAT ON (B)(6) 2015 THE PATIENT UNDERWENT THE PRIMARY SURGERY WITH THE PINNACLE, THE HEAD, AND THE SUMMIT POROCOAT. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. AFTER THE SURGERY, IT WAS CONFIRMED THAT CUP WAS LOOSENED. ADDITIONALLY, INFECTION WAS SUSPECTED. THEREFORE, ALL THE IMPLANTS WILL BE REMOVED. ON (B)(6) 2022 THE CUP AND THE STEM WILL BE REMOVED. ON (B)(6) 2022, IF THE PATIENT IS NOT INFECTED AND THERE IS NO PROBLEM, THE IMPLANTS WILL BE REPLACED WITH OTHER COMPANY¿S IMPLANTS. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Unspecified Infection
MAUDE report 15051649 ↗InjuryJul 10, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT WAS REVISED TO ADDRESS PERIPROSTHETIC FRACTURE. DOI: UNKNOWN; DOR: (B)(6) 2018; RIGHT HIP.
Patient problems: Bone Fracture(s)
MAUDE report 7674952 ↗InjuryJun 29, 2017Insufficient Device Problem Information; Insufficient Device Problem Information
ASR REVISION, ASR XL RIGHT, REASON(S) FOR REVISION: UNKNOWN.
Patient problems: No Information
MAUDE report 6678937 ↗
Other Prosthesis, hip, semi-constrained, metal/polymer, cemented devices
- NA 1365-51-000Depuy (Ireland) · Prosthesis, hip, semi-constrained, metal/polymer, cemented753 reports
- NA 1365-50-000Depuy (Ireland) · Prosthesis, hip, semi-constrained, metal/polymer, cemented412 reports
- ARTICUL/EZE 1365-21-000Depuy (Ireland) · Prosthesis, hip, semi-constrained, metal/polymer, cemented1 recall280 reports
- ARTICUL/EZE 1365-11-000Depuy (Ireland) · Prosthesis, hip, semi-constrained, metal/polymer, cemented1 death262 reports
- LFIT 6260-9-236Howmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, metal/polymer, cemented256 reports
- PINNACLE GRIPTION 1217-32-052Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/polymer, cemented2 deaths239 reports
- ELEOS™ 25002111EOnkos Surgical, Inc. · Prosthesis, hip, semi-constrained, metal/polymer, cemented3 deaths230 reports
- Novation 130-36-52Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented2 recalls124 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- 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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