Novation Ceramic AHS 140-36-13Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10885862025524), received between Aug 17, 2020 and Aug 17, 2020 — classified as 1 injury.

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

Most reported problems

Recent adverse event reports

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

• InjuryAug 17, 2020Fracture; Fracture

  ONE YEAR AGO, APPROXIMATELY (B)(6) OF 2019, THE PATIENT PRESENTED WITH A SQUEAKING IN HER OPERATIVE HIP. THE INITIAL LEFT THA WAS COMPLETED APPROXIMATELY 5 YEARS PRIOR. THE (B)(6) Y/O FEMALE PATIENT HAS A ¿HIGH BMI¿ AND WAS IN PAIN LEADING UP TO THE REVISION. THE CERAMIC LINER FRACTURED. THE CERAMIC HEAD LODGED INTO A HOLE IN THE CUP AND BORE THROUGH. THE CUP, SCREWS, AND LINER FRAGMENTS WERE REMOVED. THE CERAMIC HEAD WAS REMOVED AS WELL AND REVISED TO A COMPETITIVE CUP WITH A CERAMIC OPTION HEAD. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. DEVICES WAS DISPOSED OF BY THE FACILITY.

  Patient problems: Failure of Implant

  MAUDE report 10417700 ↗