C-STEM 1570-04-090Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10603295059615), received between Aug 2, 2017 and Dec 4, 2025 — classified as 6 injuries, 1 malfunction.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (3 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• InjuryApr 9, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

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

  Patient problems: Insufficient Information

  MAUDE report 19072397 ↗
• InjuryMar 21, 2024Migration; Migration

  PATIENT HAD PRIMARY HIP REPLACEMENT ON (B)(6) 2008. PATIENT COMPLAINS OF LEG LENGTH DISCREPANCY AND ONCE HIP WAS X-RAYED SHOWED THAT THE C-STEM IMPLANT HAD SUBSIDED DOWN THE FEMUR. THE PATIENT HADN¿T COMPLAINED OF ANY PAIN. ONCE THE HIP WAS EXPOSED THE FEMORAL IMPLANT WAS REMOVED AND POLYETHYLENE LINER IN THE ACETABULUM WAS REPLACED FROM A 32MM TO A 36MM AND THE CEMENT WAS REMOVED FROM THE FEMUR. THE FEMUR WAS THEN PREPARED TO ACCEPT A RECLAIM STEM AND PROXIMAL BODY. CASE WENT STRAIGHT FORWARD WITH NO ISSUES. REVISED STEM AND ACETABULUM WAS VERY STABLE AT THE END OF THE CASE. ACETABULUM SHELL WAS NOT REVISED.

  Patient problems: Physical Asymmetry

  MAUDE report 18956351 ↗
• InjuryApr 17, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

  C-STEM WAS IMPLANTED ON (B)(6) 2020 AT WAKEFIELD HOSPITAL, THIS WAS TO REVISE A DHS WHICH HAD BEEN IMPLANTED A YEAR EARLIER, THE PATIENT HAD PRESENTED WITH AVN OF THE FEMORAL HEAD. IMPLANT WAS LOOSE, APPEARED TO BE INFECTED. ALL IMPLANTS AND CEMENT WAS REMOVED AND REVISION IMPLANTS REPLACED.

  Patient problems: Unspecified Infection

  MAUDE report 16751877 ↗
• InjuryJan 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE COMPONENTS WERE REMOVED DUE TO INFECTION. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2021, DOR: (B)(6) 2021, AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 13257901 ↗
• MalfunctionAug 2, 2017Loss of Osseointegration; Loss of Osseointegration

  SYNERGRY INDICATES THAT THE PATIENT HAS SINCE FALLEN AND SUFFERED A PERIPROSTHETIC FRACTURE OF THE FEMUR RESULTING IN A LOOSE FEMORAL STEM.

  Patient problems: No Information

  MAUDE report 6759653 ↗