C-STEMRecalls & reported problems across all models
Depuy (Ireland) · 30 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 130
- Deaths reported
- 1
- Injuries reported
- 113
- Recalls
- 0
We found 30 models of C-STEM by Depuy (Ireland) in the FDA's device registry (GUDID). Together they are named in 130 adverse event reports in the FDA's MAUDE database, received between Jun 29, 2017 and Sep 3, 2026 — classified as 1 death, 113 injuries, 16 malfunctions.
The most frequently reported specific device problem is “Fracture” (26 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 C-STEM problems
Device problems
- Adverse Event Without Identified Device or Use Problem51
- Fracture26
- Loss of or Failure to Bond16
- Insufficient Device Problem Information6
- Appropriate Device Problem Term/Code Not Available4
- Degraded4
- Corroded3
- Migration3
Patient problems
- No Code Available27
- Pain23
- Insufficient Information17
- Limb Fracture17
- Unspecified Infection17
- Fall16
- Bone Fracture(s)15
- Not Applicable9
C-STEM models
30 models, most reported first. Each model has its own page with its reports, recalls and device details.
- C-STEM 1570-14-070PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED17 reports
- C-STEM 1570-14-085Prosthesis, hip, semi-constrained, metal/polymer, cemented13 reports
- C-STEM 1570-04-070Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented12 reports
- C-STEM 1570-04-085Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented10 reports
- C-STEM 1570-14-090Prosthesis, hip, semi-constrained, metal/polymer, cemented9 reports
- C-STEM 1570-04-090Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented7 reports
- C-STEM 9612-12-500Prosthesis, hip, semi-constrained, metal/polymer, cemented1 death7 reports
- C-STEM 9613-15-000Prosthesis, hip, semi-constrained, metal/polymer, cemented7 reports
- C-STEM 9611-62-000Prosthesis, hip, semi-constrained, metal/polymer, cemented5 reports
- C-STEM 1570-14-100Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented4 reports
- C-STEM 9612-10-500Prosthesis, hip, semi-constrained, metal/polymer, cemented4 reports
- C-STEM 9611-63-000Prosthesis, hip, semi-constrained, metal/polymer, cemented3 reports
- C-STEM 9611-64-000Prosthesis, hip, semi-constrained, metal/polymer, cemented3 reports
- C-STEM 9611-72-000Prosthesis, hip, semi-constrained, metal/polymer, cemented3 reports
- C-STEM 9611-74-000Prosthesis, hip, semi-constrained, metal/polymer, cemented3 reports
- C-STEM 9612-14-500Prosthesis, hip, semi-constrained, metal/polymer, cemented3 reports
- C-STEM 1570-04-100Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented2 reports
- C-STEM 1570-04-110Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented2 reports
- C-STEM 1570-14-135Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented2 reports
- C-STEM 9611-67-000Prosthesis, hip, semi-constrained, metal/polymer, cemented2 reports
- C-STEM 9611-70-000Prosthesis, hip, semi-constrained, metal/polymer, cemented2 reports
- C-STEM 9612-46-000Prosthesis, hip, semi-constrained, metal/polymer, cemented2 reports
- C-STEM 1570-14-120Prosthesis, hip, semi-constrained, metal/polymer, cemented1 report
- C-STEM 9611-60-000Prosthesis, hip, semi-constrained, metal/polymer, cemented1 report
- C-STEM 9611-61-000Prosthesis, hip, semi-constrained, metal/polymer, cemented1 report
- C-STEM 9611-77-000REAMER1 report
- C-STEM 9612-16-500Prosthesis, hip, semi-constrained, metal/polymer, cemented1 report
- C-STEM 9613-07-000Prosthesis, hip, semi-constrained, metal/polymer, cemented1 report
- C-STEM 1570-24-092Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 report
- C-STEM 2580-00-115Instruments designed for press-fit osteochondral implants1 report
Recent C-STEM adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 3, 2026Loss of or Failure to Bond
Patient problems: Foreign Body Reaction; Pain
MAUDE report 50591646 ↗InjuryAug 11, 2026Fracture
It was reported that the distal part of the implant (stem) broke; periprosthetic fracture after two years in-situ. The hip was revised. All pieces were recovered. There was no surgical delay.
Patient problems: Limb Fracture
MAUDE report 50209588 ↗InjuryJul 30, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient had infection and needed to have everything removed to place an antibiotic spacer.DOI (b)(6) 2026.DOR (b)(6) 2026.Affected side-Right hip.
Patient problems: Unspecified Infection
MAUDE report 50093432 ↗InjuryJul 28, 2026Adverse Event Without Identified Device or Use Problem
It was reported that patient needed revision due to instabilityDOI: (b)(6), 2019DOR: (b)(6), 2026Affected side: Left hip
Patient problems: Joint Laxity
MAUDE report 50061391 ↗InjuryJul 28, 2026Adverse Event Without Identified Device or Use Problem
It was reported that patient needed revision due to instability.DOI: (b)(6) 2019.DOR: (b)(6) 2026.Affected side: Left hip.
Patient problems: Joint Laxity
MAUDE report 50061388 ↗InjuryJun 4, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO PAIN. DOI: (B)(6) 2026. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT HIP.
Patient problems: Pain
MAUDE report 25392851 ↗InjuryFeb 3, 2026Loss of or Failure to Bond
IT WAS REPORTED THAT THE PATIENT UNDERWENT THE HIP REVISION PROCEDURE DUE TO MIGRATION OF THE PINNACLE ACETABULAR CUP. THE STEM CAME OUT WHEN THE HEAD WAS REMOVED, THEREFORE THE STEM WAS REPLACED AS WELL. IMPLANTS WERE REPLACED WITH PINNACLE MULTIHOLE SZ 56, +4/10 LINER, 36 +12 CERAMIC HEAD AND C-STEM SZ 2 HIGH OFFSET.
Patient problems: Insufficient Information
MAUDE report 24247681 ↗InjuryJan 21, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT PATIENT REVISED FOR A PERIPROSTHETIC FRACTURE. NO DELAYS. NO BROKEN INSTRUMENTS. DOI: (B)(6) 2021. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT HIP.
Patient problems: Limb Fracture
MAUDE report 24130387 ↗InjuryJan 7, 2026Adverse Event Without Identified Device or Use Problem
PATIENT WAS INFECTED, ALL IMPLANTS WERE EXTRACTED AND A PROSTALAC SPACER WAS IMPLANTED. DOI: (B)(6) 2025, DOR: (B)(6) 2025 , AFFECTED SIDE: UNKNOWN HIP.
Patient problems: Unspecified Infection
MAUDE report 23997522 ↗InjuryDec 4, 2025Loss of or Failure to Bond; Loss of or Failure to Bond
IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE DUE TO INFECTION. THE STEM SEPARATED FROM THE CEMENT MANTLE WHEN DISSOCIATING THE TAPER. NO HARM TO THE PATIENT WAS REPORTED. THE PROCEDURE WAS DELAYED FOR ABOUT THIRTY (30) MINUTES WHILE THE NEW CEMENT HARDENED. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: UNKNOWN.
Patient problems: Unspecified Infection
MAUDE report 23716746 ↗InjuryNov 14, 2025Use of Device Problem; Use of Device Problem
FAILED TOTAL DUE TO POOR POSITIONING OF THE STEM. DOI: (B)(6) 2022. DOR: (B)(6) 2025. AFFECTED SIDE: UNKNOWN HIP.
Patient problems: Insufficient Information
MAUDE report 23554824 ↗InjuryNov 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT ON (B)(6) 2014, THE PATIENT UNDERWENT A THA SURGERY FOR OA WITH THE IMPLANTS IN QUESTION. AFTER THE SURGERY IN (B)(6) 2024, X-RAYS SHOWED NO ABNORMALITIES IN THE LINER IN QUESTION. IN (B)(6) 2025, CT SCAN REVEALED SOME WEAR (ECCENTRICITY OF THE HEAD) MOVEMENT BEHIND THE LINER. ON (B)(6) 2025, THE PATIENT VISITED THE HOSPITAL COMPLAINING OF ABNORMAL NOISE AND PAIN. AN X-RAY REVEALED SIGNIFICANT DISPLACEMENT OF THE FEMORAL HEAD CENTER. DISLOCATION AND WEAR WERE SUSPECTED, BUT THE X-RAY FINDINGS DID NOT REVEAL DISLOCATION. THE SURGEON DOUBTED THAT SUCH EXTENSIVE WEAR COULD OCCUR IN SUCH A SHORT PERIOD OF TIME, AND SUSPECTED LINER DISLOCATION. ON (B)(6) A REVISION WAS SCHEDULED FOR (B)(6) 2025. DURING THE SURGERY, A SALES REPRESENTATIVE CHECKED THE SITUATION FROM THE SURGICAL FIELD AND CONFIRMED THE FOLLOWING: THE LINER AT THE TOP OF THE CUP RIM WAS EMBEDDED INTO THE CUP, WITH THE ANTI-ROTATION TAB DESTROYED. THE DELTA HEAD HAD COLLIDED WITH THE CUP RIM AND THE TAPERED LOCKING PORTION OF THE CUP/LINER (DISCOLORED DUE TO FRICTION WITH THE HEAD), CAUSING SIGNIFICANT DAMAGE. THE SURGEON DETERMINED THAT RE-FIXING THE LINERS WOULD BE DIFFICULT, SO ALL IMPLANTS PLACED IN
Patient problems: Pain
MAUDE report 23450100 ↗InjuryOct 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THERE WAS REVISION SURGERY, HEMI HIP PROTHESIS WITH CATH CART HEAD. THERE WAS EXTREME BONE LOSS FEMORAL AND ACETABULAR SIDE, SIGNS OF METALLOSIS. PATIENT CONSEQUENCES INCLUDE POSSIBLE CAUSE OF DESTRUCTION, DISLOCATION AND REVISION. ACTION TAKEN TO RESOLVE THE ISSUE INCLUDED EXTRACTION OF THE PROSTHESIS. DEFINITE GIRDLESTONE DUE TO RECONSTRUCTABLE BONE DEFECT FEMORAL AND ACETABULAR SIDE.
Patient problems: Bone Notching; Foreign Body Reaction
MAUDE report 23434917 ↗InjurySep 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED A PERI-PROSTHETIC FRACTURE WAS DISCOVERED WITH C-STEM AMT IMPLANT. THE ORIGINAL PROCEDURE OCCURRED OVER FIVE (5) YEARS AGO. THE IMPLANTS WERE REVISED.
Patient problems: Limb Fracture
MAUDE report 22965498 ↗InjuryJul 22, 2025Material Deformation; Material Deformation
THIS PC IS RELATED TO (B)(4) WHICH REPORTS THE CAUSE OF THE REVISION SURGERY. THIS PC REPORTS THE POOR FIT OF THE STEM FOUND DURING THE REVISION SURGERY. IT WAS REPORTED THAT ON (B)(6) 2008, THE PATIENT UNDERWENT AN INITIAL SURGERY PERFORMED WITH THE IMPLANTS IN QUESTION. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. AFTER THE SURGERY ON (B)(6) 2025, A FEMORAL HEAD DISLOCATION WAS CONFIRMED. ON (B)(6) 2025, THE REVISION SURGERY WAS PERFORMED TO REPLACE THE LINER AND HEAD. DURING THE SURGERY, AN ACETABULAR CUP, POLO PRODUCT REPORTED ON (B)(4), LOOSENING WAS CONFIRMED AND THE CUP WAS REPLACED WITH A CEMENT CUP FROM OTHER COMPANY. WHEN THE HEAD WAS REPLACED WITH A NEW 9/10 TAPER HEAD, IT WAS FOUND THAT THE NECK TAPER WAS DISTORTED AND THERE WAS A POOR FIT, WHICH MAY HAVE BEEN THE CAUSE OF THE DISLOCATION, SO THE STEM WAS REMOVED AND REPLACED WITH A NEW CEMENTED STEM (C-STEM AMT). THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. AFTER THE SURGERY, THE SURGEON CONCLUDED THAT THE REASON FOR THE CUP REVISION WAS THAT BLACK TISSUE HAD FORMED AT THE BOUNDARY SURFACE, WHICH HAD CAUSED BONE DISSOLUTION AND LOOSENING. THE REASON FOR THE STEM REVISION WAS THAT, JU
Patient problems: Insufficient Information
MAUDE report 22564654 ↗
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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