C-STEM 9611-61-000Recalls & reported problems
Depuy (Ireland) · C-STEM Stem SIZE 1 9/10 TAPER CEMENTED · Class 2 · Implant
All models of C-STEM (30)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10603295235187), received between Oct 23, 2017 and Oct 23, 2017 — classified as 1 injury.
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
Device problems
- Appropriate Device Problem Term/Code Not Available1
Patient problems
- Joint Disorder1
- No Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryOct 23, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
COMPLAINT DESCRIPTION: DER STATES THAT THE PATIENT HAD A DISLOCATION. THE PATIENT UNDERWENT THE FIRST REVISION SURGERY AND A PRESSURE POINT OF THE NECK OF THE FEMORAL STEM WAS NOTED ON ONE OF THE EDGES OF THE ACETABULUM. IT IS BELIEVED THAT THE POLYETHYLENE WAS WORN AND THE HEAD CAME OUT. IN THAT FIRST REVIEW SURGERY, THE SURGEON REMOVED PART OF THE POLYTHENE AND HAD TO CUT IN HALF THE REMAINED PART OF POLYETHYLENE, RAISED THE HEAD AND PLACED A NEW CONSTRICTED INSERT.
Patient problems: Joint Disorder; No Information
MAUDE report 6968146 ↗
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page