Stryker Performance Series 6118127110Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 04546540593382), received between May 28, 2019 and Oct 28, 2025 — classified as 2 injuries, 5 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 18, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• 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 IMAGING REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23399865 ↗
• MalfunctionAug 7, 2025Break; Material Fragmentation

  WHILE DOING A TOTAL KNEE SURGERY, A STRYKER BLADE WAS BROKEN AT THE BLADE INSERTION POINT. THIS WAS OBSERVED BY OPERATING ROOM TECH ON THE FIELD. SURGEON WAS NOTIFIED AND THE BROKEN PIECE WAS IDENTIFIED AND BOTH THE BLADE AND THE BLADE FRAGMENT WERE DELIVERED TO MANAGEMENT. A POST OP X-RAY WAS ORDERED BY SURGEON.

  Patient problems: Insufficient Information

  MAUDE report 22736778 ↗
• MalfunctionJul 29, 2025Fracture; Fracture

  THIS REPORT SUMMARIZES 1 EVENT FOR THE FAILURE: FRACTURE. 1 EVENT HAD IMAGING REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22647067 ↗
• InjuryFeb 20, 2025Fracture; Fracture

  IT WAS REPORTED THAT A PIECE OF THE DEVICE WAS RETAINED IN THE PATIENT AFTER A PROCEDURE. THE PATIENT RECEIVED A SECOND PROCEDURE AND THE FRAGMENT WAS SUCCESSFULLY REMOVED. THERE WERE NO ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21425968 ↗
• MalfunctionJan 31, 2020Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT THERE WAS A PIN HOLE IN THE PACKAGING. 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.

  Patient problems: No Patient Involvement

  MAUDE report 9653981 ↗
• InjuryDec 13, 2019Fracture; Fracture

  IT WAS REPORTED THAT DURING A TOTAL KNEE ARTHROPLASTY(TKA) SURGICAL PROCEDURE, THE BLADE BROKE. IT WAS ALSO REPORTED THAT THE PATIENT REQUIRED ADDITIONAL SURGERY TO REMOVE THE BLADE FRAGMENT. IT WAS FURTHER REPORTED THAT THERE WERE NO ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: Foreign Body In Patient

  MAUDE report 9469016 ↗
• MalfunctionMay 28, 2019Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT THERE WAS A POTENTIAL STERILITY BREACH ON THE PACKAGING OF THE DEVICE. 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.

  Patient problems: No Patient Involvement

  MAUDE report 8646525 ↗