C-STEM 1570-04-070Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10603295059592), received between Jan 8, 2018 and Jan 21, 2026 — classified as 12 injuries.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (5 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, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• InjuryJun 24, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE CEMENTED C-STEM LOOSE CAUSING PATIENT PAIN. LOOSENING INTERFACE: CEMENT TO IMPLANT . CEMENT MANUFACTURER: UNKNOWN. DOI: (B)(6) 2024. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT HIP.

  Patient problems: Pain

  MAUDE report 22321198 ↗
• InjuryApr 8, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  THE PATIENT WAS REVISED DUE TO ASEPTIC LOOSENING OF FEMORAL STEM AT THE CEMENT TO IMPLANT INTERFACE. THE CEMENT MANUFACTURER WAS UNKNOWN. UNKNOWN SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Insufficient Information

  MAUDE report 19067070 ↗
• InjuryJan 20, 2023Difficult to Remove; Difficult to Remove

  REVISION OF A C-STEM. FEMALE. LEFT SIDE. THE REASON FOR REVISION WAS DUE TO A PERIPROSTHETIC FRACTURE. PATIENT HAD A FALL. THE C-STEM AND HEAD WERE REMOVED, AND RECLAIM WAS IMPLANTED. DURALOC CUP AND LINER WERE LEFT IN SITU. STRYKER (DALL-MILES) CABLES WERE USED FOR CLOSURE OF PROXIMAL BONE. IT WAS ALSO CHALLENGING TO REMOVE THE POLY TAPER PROTECTOR FROM THE RECLAIM STEM 1977-20-190 LOT: 651324. THIS ADDED A 5MIN DELAY TO REMOVE. THE PATIENT HAD A REVISION ON (B)(6) 2022 WHERE THE CHARNLEY ELITE STEM, HEAD, AND DURALOC LINER WERE REMOVED. THE REASON FOR THIS REVISION WAS DUE TO POLY WEAR WHICH HAD CAUSED THE STEM TO LOOSEN, AND CAUSED SIGNIFICANT BONE LOSS. A C-STEM WAS IMPLANTED, AND POLY WAS REPLACED WITH A MARATHON POLY. STRYKER CABLES (DALL-MILES) WERE ALSO USED.

  Patient problems: Fall; Limb Fracture

  MAUDE report 16213848 ↗
• InjuryOct 6, 2021Fracture; Fracture

  I ATTENDED SURGERY TODAY FOR A REVISION HIP CASE WHERE A C-STEM AMT PRIMARY WAS REPLACED (DUE TO STEM FRACTURE) WITH A RECLAIM. THIS WAS SCHEDULED REVISION SURGERY SO NO IMPLICATIONS FOR EXTENDED SURGERY TIME. PRIMARY SURGERY DETAILS - SURGERY DATE: (B)(6) 2015; REVISION SURGERY DETAILS - SURGERY DATE: (B)(6) 2021.

  Patient problems: Joint Laxity

  MAUDE report 12582624 ↗
• InjuryAug 19, 2021Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS EXPLANTED DUE TO INFECTION. IMPLANTS ARE UNAVAILABLE FOR RETURN AND SOME PART NUMBERS WERE ILLEGIBLE. IT WAS ALSO INDICATED THAT THERE WAS LOOSENING OF UNKNOWN COMPONENT AT THE CEMENT TO IMPLANT INTERFACE. CEMENTED C STEM WAS LOOSE IN CEMENT MANTLE. DOI: UNKNOWN; DOR: (B)(6) 2021; AFFECTED SIDE: LEFT HIP.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12342299 ↗
• InjuryMay 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT REVISED FOR INSTABILITY. STEM AND HEAD EXCHANGED AND CONSTRAINED LINER USED. DOI: UNKNOWN; DOR: (B)(6) 2021; LEFT HIP.

  Patient problems: Joint Laxity

  MAUDE report 11869658 ↗
• InjuryFeb 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  3 WEEKS POST OP AFTER CEMENTED HEMI ARTHROPLASTY FOR FRACTURED NECK OF FEMUR. PATIENT WAS AT HOME AND FELL WHILE USING FRAME TO AMBULATE AND FRACTURED HER FEMUR.

  Patient problems: Bone Fracture(s); No Code Available

  MAUDE report 9706672 ↗
• InjuryFeb 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT TRIPPED WHILST CROSSING THE ROAD AT A PEDESTRIAN CROSSING. LANDED ON HER RIGHT SIDE WHICH RESULTED IN A PERI PROSTHETIC FRACTURE OF HER RIGHT TOTAL HIP JOINT REPLACEMENT.

  Patient problems: Bone Fracture(s); No Code Available

  MAUDE report 9706616 ↗
• InjuryJul 23, 2019Loss of or Failure to Bond; Loss of or Failure to Bond

  REVISION THR: (B)(6) HOSPITAL, (B)(6) 2019. THE PATIENT WAS COMPLAINING OF HIP PAIN, THE FEMORAL STEM WAS LOOSE. THE SURGEON WORKED ON GETTING THE STEM OUT PROXIMALLY FOR 15 MINUTES. EVENTUALLY, THE CEMENTED STEM CAME OUT VIA SLAP HAMMER WITH THE ENTIRE CEMENT MANTLE INTACT ON THE STEM. HAVE ATTACHED A PHOTO TO THE EMAIL. CORAIL STD SIZE 16 WITH 36MM/+1.5MM CERAMIC HEAD IMPLANTED. AS THE CEMENTED IMPLANT CAME OUT INTACT THERE WAS VERY LITTLE DAMAGE TO THE BONE SO A PRIMARY PROSTHESIS WAS IMPLANTED, EVENTUALLY GOOD RESULT FOR THE PATIENT. THE SURGEON WAS UNSURE WHY THE STEM HAD LOOSENED AND HAD NOT SEEN AN IMPLANT COME OUT WITH THE CEMENT MANTLE STUCK TO THE STEM BEFORE. NO AE REPORTED, NO DELAY IN THE SURGERY. MALE PATIENT, (B)(6) YEARS OLD.

  Patient problems: No Code Available; Pain

  MAUDE report 8816816 ↗
• InjuryMar 29, 2019Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT DURING THE CONVERSION FROM A HEMI TO A TOTAL, THE STEM WAS DISASSOCIATED FROM THE CEMENT DURING SEPARATION OF THE HEAD FROM STEM. ANOTHER STEM OF THE SAME SIZE WAS CEMENTED BACK IN THE EXISTING MANTLE. IT WAS ALSO REPORTED THAT THERE WAS LOOSENING OF THE STEM AT THE CEMENT TO IMPLANT INTERFACE. CEMENT USED WAS A COMPETITOR. DOI: (B)(6) 2019. DOR: (B)(6) 2019. LEFT HIP.

  Patient problems: No Code Available

  MAUDE report 8465531 ↗
• InjuryJan 8, 2018Migration or Expulsion of Device; Migration or Expulsion of Device

  SURGEON- (B)(6); OP DATE FOR REVISION - (B)(6); PREVIOUS OP DATE: (B)(6) 2017; OPERATION FOR PRIMARY HIP WAS AVN OF FEMORAL HEAD. CEMENT/CEMENT HIP (STICKERS ATTACHED) RETURNED WITH PAIN POST HIP REPLACEMENT. X-RAY SHOWS CEMENTED STEM SUBSIDED 2CM IMPLANTS AND CEMENT REMOVED. PINNACLE CUP WITH SCREWS INSERTED CORAIL STEM + 36 HEAD OUTCOME AT TIME OF SURGERY = SATISFACTORY PATIENT CONSEQUENCE? :UNKNOWN IS THE INFORMATION BEING SUBMITTED FOR THIS COMPLAINT ALL THE DETAILS THAT ARE KNOWN/AVAILABLE REGARDING THIS EVENT? : YES DOI: (B)(6) 2017, DOR: (B)(6) 2017.

  Patient problems: Pain

  MAUDE report 7171137 ↗