C-STEM 1570-14-070Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 10603295060284), received between Aug 7, 2017 and Jan 7, 2026 — classified as 17 injuries.

The most frequently reported specific device problem is “Fracture” (7 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• InjuryMar 25, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THERE WAS A REVISION OF A C-STEM PINNACLE. THE REASON FOR REVISION WAS BECAUSE THE STEM WAS LOOSE, AND THE HIP WAS UNSTABLE. NO ALLEGATION WAS MADE BY THE SURGEON IN RELATION TO THE LOOSE STEM. THE CEMENT/STEM INTERFACE WAS LOOSE. CEMENT BONE/BONE INTERFACE WAS SOUND. THE SURGEON NOTED THAT IT WAS A VERY DIFFICULT PRIMARY. IT WAS DONE BY A DIFFERENT SURGEON AND THEY STRUGGLED TO GET A SZ 1HO C-STEM IN. THE X-RAY SHOWED THAT DUE TO THE ANTERIOR-LATERAL APPROACH, THE STEM WAS PUT IN VARUS. THE HIP WAS UNSTABLE BECAUSE AT THE PRIMARY SURGERY, THE CUP WAS PLACED AT THE WRONG VERSION. THE CUP WAS EXPLANTED. IT WAS EXTREMELY WELL FIXED. THE LINER WAS EXPLANTED WITH THE SHELL, BUT THE LOT NUMBER IS UNREADABLE AS THE LINER WAS DAMAGED WHEN EXPLANTED. RECLAIM BIMENTUM WAS IMPLANTED. AFFECTED SIDE: RIGHT SIDE.

  Patient problems: Joint Laxity

  MAUDE report 21687924 ↗
• InjuryDec 4, 2024Fracture; Fracture

  IT WAS REPORTED THE SURGEON REVIEWED A CASE OF A PATIENT WITH RHEUMATOID ARTHRITIS WHO HAD PREVIOUSLY UNDERGONE BILATERAL SURGERY AT ANOTHER HOSPITAL, AND THE FEMORAL STEM HAD FRACTURED.

  Patient problems: Insufficient Information

  MAUDE report 20845050 ↗
• InjurySep 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 17725732 ↗
• InjuryAug 23, 2023Fracture; Fracture

  C-STEM THAT SNAPPED INSIDE A PATIENT IT SNAPPED AT THE NECK. POSSIBLY TOO SMALL FOR THE SIZE OF THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 17602475 ↗
• InjuryAug 17, 2023Fracture; Fracture

  IT WAS REPORTED THAT THE SIZE 1 C-STEM AMT HIGH OFFSET BROKE IN HALF AND WE ARE REVISING THE HIP TODAY. THE IMPLANT WAS IMPLANTED 1 YEAR AGO. DOI: 1 YEAR AGO. DOE: (B)(6) 2023. AFFECTED SIDE: UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 17564115 ↗
• InjuryMay 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED HIP BECAUSE OF PERIPROSTHETIC FRACTURE. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2021; DOR: (B)(6) 2022; AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Limb Fracture

  MAUDE report 14468677 ↗
• InjuryJan 6, 2022Off-Label Use; Off-Label Use

  PT HAD A HEMI ARTHROPLASTY 7 WEEKS AGO AND HAS A STRONG LINK TO SUBSTANCE ABUSE & HAD A FALL & FRACTURED. DR JENKINS REPLACED THE COMPONENTS & RE-CEMENTED THE STEM. DOI: UNKNOWN; DOR: (B)(6) 2021; UNKNOWN SIDE.

  Patient problems: Fall; Limb Fracture

  MAUDE report 13175934 ↗
• InjuryOct 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED STATES THAT THE CEMENT WAS NOT DEPUY, SIMPLEX WAS THE PRODUCT USED, UNSURE OF THE VOLUME. THE AFFECTED SIDE OF THE PATIENT WAS THE LEFT HIP.

  Patient problems: Fall; Limb Fracture

  MAUDE report 12697530 ↗
• InjurySep 13, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION OF A CSTEM/PROSTALAC AND CEMENTED MARATHON CUP FROM A FIRST STAGE REVISION ORIGINALLY DONE ON THE (B)(6) 201 AT FLINDERS PRIVATE HOSPITAL WITH SURGEON FOR INFECTION. REMOVAL OF IMPLANTS AND INSERTION OF CORAIL REVISION STEM WITH ACETABULAR COMPONENTS IMPLANTED.

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

  MAUDE report 12460164 ↗
• InjuryJul 23, 2021Osseointegration Problem; Osseointegration Problem

  PATIENT HAD A FALL AND SUFFERED A PERIPROSTHETIC FRACTURE WHICH RESULTED IN THE STEM BECOMING LOOSE. SURGEON REVISED THE STEM AND HEAD AND LEFT THE CUP AND LINER INSITU AS IT WAS INTACT WITH NO DAMAGED TO THE CERAMIC LINER HAD OCCURRED. AS THIS WAS A REVISION PROCEDURE, THERE WAS NO EXTENSION TO THE SURGICAL TIME.

  Patient problems: Fall; Inadequate Osseointegration; Limb Fracture

  MAUDE report 12217398 ↗
• InjuryJun 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO PERIPROSTHETIC FRACTURE FROM MULTIPLE FALLS. DOI: (B)(6) 2021, DOR: (B)(6) 2021, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Fall; Limb Fracture

  MAUDE report 12089655 ↗
• InjuryMay 5, 2021Fracture; Fracture

  IT WAS REPORTED THAT THERE WAS A PLANNED REVISION OF A C STEM IMPLANT DUE TO A NECK FRACTURE ON THE STEM. PATIENT UNDERGONE SURGERY TO REMOVE STEM. NO COMPLICATIONS ARISEN FROM THIS AT TIME OF THIS EMAIL.

  Patient problems: Insufficient Information

  MAUDE report 11777045 ↗
• InjuryMar 30, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS FEMORAL COMPONENT REVISION DUE TO PREPROSTHETIC FRACTURE SUSTAINED DURING A FALL. CSTEM FEMUR WAS REMOVED AND REPLACED WITH A RECLAIM REVISION STEM CONSTRUCT AND LUQUE WIRES. DOI: (B)(6) 2019. DOR: (B)(6) ) 2020. AFFECTED SIDE: LEFT HIP.

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

  MAUDE report 9898371 ↗
• InjuryMar 17, 2020Fracture; Fracture

  IT WAS REPORTED THAT THE DEVICE BROKEN IN TWO PIECES.

  Patient problems: No Code Available

  MAUDE report 9842943 ↗
• InjuryJan 8, 2018Fracture; Fracture

  PATIENT PRESENTED WITH A FRACTURED STEM. DOI: (B)(6) 2015; DOR: (B)(6) 2017. LEFT HIP.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7171222 ↗
• InjuryAug 7, 2017Fracture; Fracture

  THE PATIENT WILL BE REVISED TO ADDRESS FRACTURE OF THE C-STEM.

  Patient problems: No Information

  MAUDE report 6770719 ↗