C-STEM 9611-62-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10603295235194), received between Dec 6, 2018 and Jun 12, 2025 — classified as 5 injuries.

The most frequently reported specific device problem is “Fracture” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJun 12, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION OF CSTEM DUE TO BREAK IN STEM. A PREVIOUS CEMENT ON CEMENT REVISION WAS PERFORMED USING A SMALLER STEM IN A LARGER PATIENT. SURGEON STATED THAT THE REASON HE BELIEVED THE STEM HAD BROKEN WAS BECAUSE IT WAS TOO SMALL TO SUPPORT THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 22194562 ↗
• InjuryApr 5, 2022Loss of or Failure to Bond; Fracture; Noise, Audible; Loss of or Failure to Bond; Fracture; Noise, Audible

  REVISION HIP - GROSS FEMORAL LOOSENING & PROSTHETIC FRACTURE OF CSTEM 9/10 TAPER. IMPLANT HAD BEEN INSITU FOR APPROX. 18-20 YEARS. PATIENT HAD PAIN FOR APPROX. LAST 2 YEARS THEN HEARD A POPPING NOISE. PROXIMAL CEMENT MANTLE WAS LOOSE & STEM WAS LOOSE WITHIN THE MANTLE. DISTAL FRAGMENT OF STEM WAS ALSO LOOSE WITHIN THE CEMENT MANTLE. ALSO NON UNION OF PROXIMAL TROCHANTERIC OSTEOTOMY. DOI: UNKNOWN; DOR: (B)(6) 2022; UNKNOWN HIP.

  Patient problems: Pain

  MAUDE report 14014559 ↗
• InjuryMar 23, 2020Corroded; Degraded; Corroded; Degraded

  THE PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2004 VIA THA. IT WAS REPORTED THAT THE REVISION SURGERY WAS PERFORMED ON (B)(6) 2020 BY REPLACING THE C-STEM (P/N: UNKNOWN) AND THE CUP (P/N: UNKNOWN) DUE TO A PAIN WHICH THE PATIENT HAD LEFT AND RIGHT SIDE OF HIS HIP JOINTS AT THE SAME TIME IN AUTUMN 2019 (THE DATE WAS UNKNOWN). THE REVISION SURGERY WAS COMPLETED SUCCESSFULLY, AND IT WAS UNKNOWN WHETHER THERE WAS SURGICAL DELAY OR NOT. THE CONDITION AFTER SURGERY WAS GOOD. THE SURGEON FOUND THAT THERE WAS SOMETHING LIKE A CORROSION FROM THE MIDDLE POINT TO DISTAL PART OF THE EXPLANTED STEM. HE THOUGHT THAT THIS CAUSED THE PAIN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Code Available; Pain

  MAUDE report 9868038 ↗
• InjuryAug 16, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ASR REVISION; ASR XL; LEFT HIP. REASON FOR REVISION: PAIN. DOI: (B)(6) 2008 - DOR: (B)(6) 2019, (LEFT HIP).

  Patient problems: No Code Available; Pain

  MAUDE report 8902872 ↗
• InjuryDec 6, 2018Fracture; Fracture

  PATIENT WAS REVISED DUE TO ADDRESS FRACTURE OF STEM AND PAIN.

  Patient problems: No Code Available; Pain

  MAUDE report 8139831 ↗