NA 52856BRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00885556909393), received between May 7, 2024 and Jan 15, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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. How this data works · Data updated Oct 13, 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.

• MalfunctionJan 15, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A THA, WHILE THE PATIENT WAS UNDER ANESTHESIA, THE BOTTOM PLATE OF A CUP IMPACTOR - OFFSET POPPED OFF, LETTING THE SPRINGS AND PEGS COME OUT AS WELL. ALL PIECES RETAINED AND NOT MISSING. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24079278 ↗
• MalfunctionNov 18, 2025Break; Break

  IT WAS REPORTED THAT, DURING A CORI ASSISTED THA SURGERY, THE LOCKING MECHANISM OF A CUP IMPACTOR - OFFSET BROKE. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23586448 ↗
• MalfunctionNov 18, 2025Break; Break

  IT WAS REPORTED THAT, DURING A REAL INTELLIGENCE CORI ASSISTED THA SURGERY, THE LOCKING MECHANISM OF A CUP IMPACTOR - OFFSET BROKE AND WILL NOT LOCK ON THE IMPLANT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23586292 ↗
• MalfunctionFeb 4, 2025Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING A REAL INTELLIGENCE CORI ASSISTED THA SURGERY, WHILE IMPACTING, IT WAS NOTICED THAT A SILVER PLATE CAME OFF. AFTER FURTHER INVESTIGATION, IT WAS FOUND THAT IT CAME FROM ONE (1) BL OFFSET CUP IMPACTOR UNIVERSAL. IT WAS THE SMALL PLATE THAT IS UNDERNEATH THE IMPACTOR. A SPRING, AND WHAT APPEARED TO BE A NUT, WERE ALSO FOUND TO BE DETACHED FROM THE IMPACTOR. NO BROKEN PIECES FELL INTO OR WERE LEFT IN PATIENT. THE PROCEDURE WAS RESUMED WITHOUT DELAY CAUTIOUSLY USING THE SAME DEVICE, AND NO INJURIES WERE REPORTED AS A RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21307031 ↗
• MalfunctionMay 7, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING CORI ASSISTED THA SURGERY, AFTER IMPACTING THE CUP AND REMOVING THE BL OFFSET CUP IMPACTOR UNIVERSAL, THE LATCH ON THE FLAT SURFACE FELL OFF ALONG WITH THE SCREW AND SPRING. TECH WAS UNABLE TO PUT IT BACK TOGETHER. THIS OCCURRED AFTER THE CUP HAD BEEN PLACED AND WASN¿T NEEDED ANYMORE. THERE WERE NO PIECES THAT ENDED UP IN THE PATIENT AS A RESULT OF THIS BREAK. SURGERY WAS RESUMED WITHOUT ANY DELAY. NO INJURIES TO THE PATIENT WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19258203 ↗