C-STEM 1570-04-100Recalls & reported problems
Depuy (Ireland) · C-STEM AMT Cemented Stem Standard Offset Size 4 12/14 TAPER · Class 2 · Implant
All models of C-STEM (30)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295059639), received between Sep 19, 2019 and Mar 15, 2022 — classified as 2 injuries.
The most frequently reported specific device problem is “Difficult to Remove” (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
- Difficult to Remove1
- Loss of or Failure to Bond1
Patient problems
- Bone Fracture(s)1
- No Clinical Signs, Symptoms or Conditions1
- No Code Available1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryMar 15, 2022Loss of or Failure to Bond; Difficult to Remove; Loss of or Failure to Bond; Difficult to Remove
TOTAL HIP REPLACEMENT REVISION DUE TO POSTERIOR DISLOCATION. PREVIOUS REVISION OF PRIMARY LINER TO CONSTRAINED LINER WAS ON (B)(6) 2021. ENTIRE CONSTRUCT, INCLUDING FEMUR, WAS REVISED AS WHEN THE HEAD WAS REMOVED THE STEM CAME OUT AT THE SAME TIME. REASON FOR REVISION WAS RECURRENT DISLOCATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13768971 ↗InjurySep 19, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PERIPROSTHETIC FRACTURE OCCURRED 1 WEEK AGO. REQUIRED REVISION OF FEMORAL STEM AND EXCHANGE OF ACETABULAR LINER FOR CONSTRAINED LINER, DUE TO PATIENT HAVING DEMENTIA AND TO HELP ENSURE STABILITY POST OP (LINER NOT WORN).
Patient problems: Bone Fracture(s); No Code Available
MAUDE report 9088292 ↗
Other Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented devices
- BIOLOX DELTA 1365-32-310Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented551 reports
- PINNACLE ALTRX 1221-36-052Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented481 reports
- BIOLOX DELTA 1365-32-320Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 death314 reports
- BIOLOX DELTA 1365-36-720Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 death189 reports
- DJO SURGICAL 400-03-362Encore Medical, L.P. · Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented187 reports
- Anthology 71365705Smith & Nephew, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented176 reports
- BIOLOX DELTA 1365-40-710Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented170 reports
- PINNACLE GRIPTION 1217-32-054Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented169 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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