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C-STEM 9613-07-000Recalls & reported problems

Depuy (Ireland) · C-STEM Revision Stem - Length 200mm SIZE 4 9/10 TAPER CEMENTED · Class 2 · Implant

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10603295236757), received between Apr 4, 2018 and Apr 4, 2018 — classified as 1 injury.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Insufficient Device Problem Information1

Patient problems

  • Not Applicable1
  • Pain1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryApr 4, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

    THE PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2009 VIA THA. IT WAS REPORTED THAT THE REVISION SURGERY WAS PERFORMED (DATE OF THE REVISION WAS UNKNOWN) BY REPLACING THE CUP AND HEAD DUE TO THE PAIN. NO FURTHER INFORMATION WAS PROVIDED BY THE HOSPITAL. DOI: (B)(6) 2009; DOR:UNKNOWN; UNKNOWN HIP.

    Patient problems: Not Applicable; Pain

    MAUDE report 7395253 ↗

Other Prosthesis, hip, semi-constrained, metal/polymer, cemented devices

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.