Stryker Performance Series 6125089090Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04546540501479), received between May 21, 2019 and Oct 29, 2019 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 29, 2019Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT THE BLADE BROKE AT THE MOUNT DURING A SURGICAL PROCEDURE. IT WAS ALSO REPORTED THAT THERE WERE NO DELAYS AND NO ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9251723 ↗
• MalfunctionOct 22, 2019Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT DURING TWO SEPARATE SURGICAL PROCEDURES, IT WAS NOTED THAT THE BLADE BROKE WHERE IT FITS INTO THE HANDPIECE. IT WAS ALSO REPORTED THERE WERE NO ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT A MINOR DELAY OCCURRED AS A RESULT OF THE EVENT. IT WAS ALSO REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9220426 ↗
• MalfunctionOct 22, 2019Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT DURING TWO SEPARATE SURGICAL PROCEDURES, IT WAS NOTED THAT THE BLADE BROKE WHERE IT FITS INTO THE HANDPIECE. IT WAS ALSO REPORTED THERE WERE NO ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT A MINOR DELAY OCCURRED AS A RESULT OF THE EVENT. IT WAS ALSO REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9220420 ↗
• MalfunctionMay 21, 2019Break; Break

  IT WAS REPORTED THAT THE BLADE BROKE OFF IN THE SAW AT THE MOUNT DURING A TOTAL KNEE ARTHROPLASTY PROCEDURE. IT WAS ALSO REPORTED THAT THERE WERE NO DELAYS AND NO ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8627721 ↗