Stryker Performance Series 6118097090Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 04546540501394), received between Jun 22, 2020 and Apr 17, 2026 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Delivered as Unsterile Product” (5 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 17, 2026Fracture

  THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. EVENTS OCCURRED BETWEEN (B)(6) 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 24911747 ↗
• MalfunctionJun 22, 2020Delivered as Unsterile Product; No Apparent Adverse Event; Delivered as Unsterile Product; No Apparent Adverse Event

  IT WAS REPORTED THAT DURING INCOMING INSPECTION, THE CUSTOMER NOTICED FOREIGN MATERIAL INSIDE THE PACKAGE. 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 10178554 ↗
• MalfunctionJun 22, 2020Delivered as Unsterile Product; No Apparent Adverse Event; Delivered as Unsterile Product; No Apparent Adverse Event

  IT WAS REPORTED THAT DURING INCOMING INSPECTION, THE CUSTOMER NOTICED FOREIGN MATERIAL INSIDE THE PACKAGE. 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 10178545 ↗
• MalfunctionJun 22, 2020Delivered as Unsterile Product; No Apparent Adverse Event; Delivered as Unsterile Product; No Apparent Adverse Event

  IT WAS REPORTED THAT DURING INCOMING INSPECTION, THE CUSTOMER NOTICED FOREIGN MATERIAL INSIDE THE PACKAGE. 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 10178544 ↗
• MalfunctionJun 22, 2020Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT DURING INCOMING INSPECTION, THE CUSTOMER NOTICED FOREIGN MATERIAL INSIDE THE PACKAGE. 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 10178541 ↗
• MalfunctionJun 22, 2020Delivered as Unsterile Product; No Apparent Adverse Event; Delivered as Unsterile Product; No Apparent Adverse Event

  IT WAS REPORTED THAT DURING INCOMING INSPECTION, THE CUSTOMER NOTICED FOREIGN MATERIAL INSIDE THE PACKAGE. 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.IT WAS SUBSEQUENTLY CONFIRMED THAT THERE WAS NO IMPACT TO THE STERILITY OF THE PACKAGE FOLLOWING INSPECTION OF THE RETURNED DEVICE.

  Patient problems: No Patient Involvement

  MAUDE report 10178539 ↗