C-STEM 1570-14-100Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10603295060321), received between Nov 12, 2020 and May 7, 2025 — classified as 4 injuries.

The most frequently reported specific device problem is “Malposition of Device” (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

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryMay 7, 2025Osseointegration Problem; Osseointegration Problem

  THAYER SCHOOL OF ENGINEERING AT DARTMOUTH FIRST REPORT OF RETRIEVALS FOR STATEMENT OF WORK 10 FOR Q1 OF 2025. DARTMOUTH IS THE RESEARCH LOCATION, AND NOT THE FACILITY OF PLACEMENT. A DEPUY SYNTHES IMPLANT WAS REVISED AND REVIEWED FOR ANALYSIS. REASON FOR REVISION: REVISION DUE A LOOSE FEMORAL STEM.

  Patient problems: Inadequate Osseointegration

  MAUDE report 21979758 ↗
• InjuryOct 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO FEMORAL FRACTURE. DOI: (B)(6) 2022. DOR: (B)(6) 2022. UNKNOWN HIP.

  Patient problems: Limb Fracture

  MAUDE report 15672967 ↗
• InjuryMay 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT SUSTAINED A PERI PROSTHETIC FRACTURE FROM A FALL. THIS PATIENT HAD A CSTEM/PINNACLE IMPLANTED (B)(6) 2011. STEM AND HEAD REQUIRED TO BE REVISED DUE TO THE LOCATION OF THE FRACTURE AND FAILURE OF CABLES AND A PERIPROSTHETIC PLATE FROM A PREVIOUS FALL AT THE BEGINNING OF 2022. DOI: (B)(6) 2011. DOR: (B)(6) 2022. UNKNOWN SIDE.

  Patient problems: Fall; Limb Fracture

  MAUDE report 14305150 ↗
• InjuryNov 12, 2020Malposition of Device; Malposition of Device

  REMOVAL OF C-STEM FEMORAL IMPLANT AND PINNACLE HEAD FROM A PATIENT FOLLOWING A FALL THAT RESULTED IN A LARGE SPIRAL FRACTURE OF THE FEMUR. THE FRACTURE OF THE FEMUR CAUSED A THE CEMENT MANTLE TO BE OPENED AND THE STEM TO BE MALALIGNED.

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

  MAUDE report 10831593 ↗