Stryker Performance Series 6125127090Recalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 04546540501516), received between Aug 17, 2018 and Apr 22, 2026 — classified as 28 malfunctions.

The most frequently reported specific device problem is “Fracture” (20 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 25 most recent of 28 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 22, 2026Fracture

  THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. EVENTS OCCURRED BETWEEN JANUARY 1 ¿ MARCH 31 2026. THIS REPORT SUMMARIZES 4 EVENTS FOR THE FAILURE: FRACTURE. - 2 EVENTS HAD NO HEALTH CONSEQUENCES OR IMPACT. - 2 EVENTS HAD IMAGING REQUIRED.

  Patient problems: Device Embedded In Tissue or Plaque; Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24954376 ↗
• MalfunctionNov 7, 2025Fracture; Fracture

  NO NEW INFORMATION.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23496717 ↗
• MalfunctionOct 28, 2025Fracture; Fracture

  THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. EVENTS OCCURRED BETWEEN JULY 1 ¿ SEPTEMBER 30 2025. THIS REPORT SUMMARIZES 1 EVENT FOR THE FAILURE: FRACTURE. 1 EVENT HAD NO HEALTH CONSEQUENCES OR IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23399838 ↗
• MalfunctionJul 29, 2025Fracture; Fracture

  THIS REPORT SUMMARIZES 3 EVENTS FOR THE FAILURE: FRACTURE. - 3 EVENTS HAD NO HEALTH CONSEQUENCES OR IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22647261 ↗
• MalfunctionApr 21, 2025Fracture; Fracture

  THIS REPORT SUMMARIZES 2 MALFUNCTION EVENTS IN WHICH THE DEVICE OR CUTTING ACCESSORY FRACTURED. - 2 EVENTS HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21876851 ↗
• MalfunctionApr 21, 2025Delivered as Unsterile Product; Delivered as Unsterile Product

  THIS REPORT SUMMARIZES 5 MALFUNCTION EVENTS IN WHICH THE DEVICE WAS REPORTEDLY RECEIVED IN SUCH A MANNER TO INDICATE THAT ITS STERILITY HAD BEEN COMPROMISED. - 5 EVENTS HAD THE PROBLEM IDENTIFIED DURING A NON-CLINICAL PROCEDURE; THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21875914 ↗
• MalfunctionJan 21, 2025Fracture; Fracture

  THIS REPORT SUMMARIZES 2 MALFUNCTION EVENTS IN WHICH THE DEVICE OR CUTTING ACCESSORY FRACTURED. - 2 EVENTS HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21201193 ↗
• MalfunctionOct 21, 2024Fracture; Fracture

  THIS REPORT SUMMARIZES 2 MALFUNCTION EVENTS IN WHICH THE DEVICE OR CUTTING ACCESSORY FRACTURED. 1 EVENT HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT. 1 EVENT HAD INSUFFICIENT INFORMATION RECEIVED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20497852 ↗
• MalfunctionJul 24, 2024Fracture; Fracture

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE OR CUTTING ACCESSORY FRACTURED. - 1 EVENT HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19816759 ↗
• MalfunctionJan 22, 2024Fracture; Fracture

  THIS REPORT SUMMARIZES 4 MALFUNCTION EVENTS IN WHICH THE DEVICE OR CUTTING ACCESSORY FRACTURED. 4 EVENTS HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18557278 ↗
• MalfunctionOct 23, 2023Fracture; Fracture

  THIS REPORT SUMMARIZES 5 MALFUNCTION EVENTS IN WHICH THE DEVICE OR CUTTING ACCESSORY FRACTURED. - 2 EVENTS HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT. - 3 EVENTS HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17992801 ↗
• MalfunctionJul 26, 2023Fracture; Fracture

  THIS REPORT SUMMARIZES 4 MALFUNCTION EVENTS IN WHICH THE DEVICE OR CUTTING ACCESSORY FRACTURED. 4 EVENTS HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17398727 ↗
• MalfunctionMay 19, 2023Fracture; Fracture

  IT WAS REPORTED, THAT DURING A KNEE REPLACEMENT PROCEDURE. THE BLADE BROKE AT THE MOUNT. IT WAS ALSO REPORTED, THAT THERE WERE NO ADVERSE CONSEQUENCES, NO MEDICAL INTERVENTION 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 16962730 ↗
• MalfunctionApr 24, 2023Fracture; Fracture

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE OR CUTTING ACCESSORY FRACTURED. - 1 EVENT HAD INSUFFICIENT INFORMATION RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16801619 ↗
• MalfunctionJan 6, 2023Fracture; Fracture

  IT WAS REPORTED TO STRYKER VIA SWISS MEDIC VK_20221221_52 , THAT DURING A SURGICAL PROCEDURE, BOTH WINGS ON THE MOUNT OF THE BLADE BROKE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16113938 ↗
• MalfunctionNov 30, 2022Delivered as Unsterile Product; Delivered as Unsterile Product

  THE USER FACILITY REPORTED THAT A PUNCTURE WAS OBSERVED IN THE PACKAGING OF A BLADE PRIOR TO OPENING. THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15885995 ↗
• MalfunctionMay 11, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING A TOTAL KNEE PROCEDURE, THE SAW BLADE BROKE. IT WAS ALSO REPORTED THAT THERE WERE NO ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THERE WAS A DELAY IN MINUTES AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14365121 ↗
• MalfunctionAug 9, 2021Fracture; Fracture

  IT WAS REPORTED THAT DURING A TOTAL KNEE ARTHROPLASTY, THE BLADE BROKE AT CUTTING END AND 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 12297285 ↗
• MalfunctionJan 15, 2021Fracture

  IT WAS REPORTED THAT DURING A TOTAL KNEE ARTHROPLASTY PROCEDURE, THE BLADE BROKE. 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 11179700 ↗
• MalfunctionNov 16, 2020Fracture; Fracture

  IT WAS REPORTED THAT DURING A PROCEDURE THE CUTTING END OF THE BLADE BROKE. IT WAS ALSO REPORTED THAT AN X-RAY WAS PERFORMED TO CONFIRM THERE WERE NO FRAGMENTS REMAINING IN THE PATIENT. IT WAS ALSO REPORTED THAT THERE WAS A DELAY OF APPROXIMATELY ONE HOUR. IT WAS FURTHER REPORTED THERE WERE NO ADVERSE CONSEQUENCES AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10844211 ↗
• MalfunctionSep 8, 2020Fracture; Fracture

  IT WAS REPORTED THAT DURING A TOTAL KNEE REPLACEMENT PROCEDURE, THE BLADE BROKE IN THE MOUNT AND THE CUTTING END. IT WAS ALSO REPORTED THAT THERE WAS A FIFTEEN MINUTE DELAY DUE TO PERFORMING AN X-RAY ON THE PATIENT INTRAOPERATIVELY. IT WAS FURTHER REPORTED THAT THERE WERE NO ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT AND THE PROCEDURE WAS COMPLETE SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10503397 ↗
• MalfunctionJul 20, 2020Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT DURING INCOMING INSPECTION AT THE HOSPITAL, SMALL PUNCTURE HOLES WERE IDENTIFIED ON THE PACKAGING OF TWO DEVICES. IT WAS ALSO REPORTED THAT THIS EVENT DID NOT OCCUR DURING A SURGICAL PROCEDURE, AND THERE WAS NO DELAY OR ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT. THIS REPORT IS FOR THE SECOND PACKAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement

  MAUDE report 10295128 ↗
• MalfunctionJul 20, 2020Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT DURING INCOMING INSPECTION AT THE HOSPITAL, SMALL PUNCTURE HOLES WERE IDENTIFIED ON THE PACKAGING OF TWO DEVICES. IT WAS ALSO REPORTED THAT THIS EVENT DID NOT OCCUR DURING A SURGICAL PROCEDURE, AND THERE WAS NO DELAY OR ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT. THIS REPORT IS FOR THE FIRST PACKAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement

  MAUDE report 10295127 ↗
• MalfunctionMay 31, 2019Break; Break

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, THE BLADE BROKE. IT WAS ALSO REPORTED THAT THE BROKEN PIECE WAS RETRIEVED FROM THE PATIENT. IT WAS FURTHER REPORTED THAT THERE WERE WAS A 10 MINUTE DELAY AS A RESULT OF THIS EVENT. IT WAS ALSO REPORTED THAT THERE WAS NO ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8659624 ↗
• MalfunctionOct 19, 2018Break; Break

  IT WAS REPORTED THAT DURING A TOTAL KNEE PROCEDURE, 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 Consequences Or Impact To Patient

  MAUDE report 7986813 ↗