Stryker Performance Series 6113119090Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 04546540593290), received between Jun 9, 2021 and Apr 21, 2025 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Fracture” (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. 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 21, 2025Fracture; Fracture

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE OR CUTTING ACCESSORY FRACTURED. 1 EVENT REQUIRED IMAGING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21876042 ↗
• MalfunctionJan 24, 2025

  DURING THE PATIENT'S LEFT TOTAL KNEE ARTHROPLASTY, IT WAS NOTICED THERE WAS A SMALL, CRESCENT-SIZED PIECE OF METAL MISSING FROM A USED SAW BLADE. SEARCHES IN AND AROUND THE FIELD PRODUCED NO RESULTS. X-RAY WAS TAKEN, RADIOLOGIST STATED HE COULD NOT FIND ANY RADIOPAQUE FOREIGN BODY OF THE DESCRIPTION. REST OF THE SURGERY CONCLUDED WITH NO FURTHER INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21228610 ↗
• MalfunctionNov 9, 2022Fracture; Fracture

  IT WAS REPORTED VIA MEDWATCH 4900240000-2022-8099: THAT DURING A LEFT KNEE ARTHROPLASTY, THE BLADE BROKE AT THE TEETH. IT WAS ALSO REPORTED THAT THERE WERE NO ADVERSE CONSEQUENCES AND NO DELAYS AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15763915 ↗
• MalfunctionOct 14, 2022Break

  LEFT KNEE ARTHROPLASTY. NARROW SAGITTAL SAW BLADE BROKE WHILE DOCTOR WAS COMPLETING THE FEMORAL CUT.

  Patient problems: Insufficient Information

  MAUDE report 15612123 ↗
• MalfunctionApr 26, 2022Fracture; Fracture

  IT WAS REPORTED VIA MEDWATCH REPORT (B)(4), THAT DURING A TOTAL KNEE ARTHROPLASTY, THE BLADE BROKE AT THE MOUNT. IT WAS ALSO REPORTED THAT THERE WERE NO ADVERSE CONSEQUENCES AND NO DELAYS AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14210580 ↗
• MalfunctionMar 31, 2022Misconnection

  STRYKER SAGITTAL BLADE FAILED AT SMALL BATTERY CONNECTION SITE DURING TOTAL KNEE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13964516 ↗
• MalfunctionAug 10, 2021Fracture; Fracture

  IT WAS REPORTED VIA MEDWATCH REPORT # (B)(4), THAT THE BLADE BROKE DURING A RIGHT TOTAL KNEE ARTHROPLASTY AT THE CUTTING END. IT WAS ALSO REPORTED THAT THERE WERE NO ADVERSE CONSEQUENCES AND NO DELAYS AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12300848 ↗
• MalfunctionJun 9, 2021Break

  BLADE BROKE DURING USE OF SURGICAL PROCEDURE.

  Patient problems: Insufficient Information

  MAUDE report 11965050 ↗