C-STEM 9611-72-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295235279), received between Sep 29, 2017 and Apr 4, 2023 — classified as 3 injuries.

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

• InjuryApr 4, 2023Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PRIMARY SURGERY WAS PERFORMED WITH THE IMPLANTS IN QUESTION. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. ON (B)(6) 2023, IT WAS REPORTED THE REVISION SURGERY IS SCHEDULED ON UNKNOWN DATE DUE TO THE SUSPECTED METAL-ON-METAL. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Foreign Body Reaction

  MAUDE report 16673052 ↗
• InjuryApr 27, 2020Degraded; Mechanical Problem; Device Dislodged or Dislocated; Degraded; Mechanical Problem; Device Dislodged or Dislocated

  THE PRIMARY SURGERY WAS PERFORMED ABOUT 10 YEARS AGO (THE DATE WAS UNKNOWN) VIA THA WITH THE HEAD (P/N: 962711000), THE STEM (P/N: 961172000), THE LINER (P/N: 121887358) AND THE CUP (P/N: 121780058, KYOCERA'S PRODUCT). IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE DISLOCATION OF THE HEAD WAS OCCURRED. THE REVISION SURGERY WAS SCHEDULED ON (B)(6) 2020. THE REASON OF THE DISLOCATION WAS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE. THE REVISION SURGERY WAS PERFORMED ON (B)(6) 2020 BY REPLACING THE STEM, THE LINER AND THE HEAD (THE HEAD WAS DISLOCATED IN THE BODY). THE SURGEON COMMENTED THAT THE TRUNNION OF THE STEM WAS SEEMED BLACK CORROSION IN A WIDE SPHERE, AND THE CORROSION MIGHT CAUSED THE DISLOCATION OF THE HEAD. IT WAS CONFIRMED THAT THE SCREWS AND CUP (KYOCERA'S PRODUCT) WERE NOT RETURNED. THEY WERE REMAINED IN THE BODY.

  Patient problems: Injury; Joint Dislocation; Joint Disorder; No Code Available

  MAUDE report 10002475 ↗
• InjurySep 29, 2017Fracture; Fracture

  THE PATIENT WAS REVISED TO ADDRESS BROKEN STEM. IT WAS ALSO REPORTED THAT PATIENT HEARD CRACK AS THE FEMORAL NECK BROKE.

  Patient problems: Joint Disorder; No Information

  MAUDE report 6903966 ↗